August 17, 2011 11-33
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Sano Very Berry Yogurt Parfait, 8.5 ounce packages. Recall # F-1581-2011;
2) Sano Triple Cherry Yogurt Parfait, 8.0 ounce packages. Recall # F-1582-2011;
3) Race Trac, Turkey Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-1583-2011;
4) Race Trac, Egg Salad, 4.95 ounce packages. Recall # F-1584-2011;
5) Race Trac, Chicken Salad, 4.95 ounce packages. Recall # F-1585-2011;
6) Race Trac, Chicken Quarter Pounder, 7.8 ounce packages. Recall # F-1586-2011;
7) Race Trac, Turkey Quarter Pounder, 7.38 ounce packages. Recall # F-1587-2011;
8) Race Trac, Chicken Quarter Pounder with Tomatoes, 8 ounce packages. Recall # F-1588-2011;
9) Race Trac, Jumbo BBQ Pork Sandwich, 8.4 ounce packages. Recall # F-1589-2011;
10) Race Trac, Ham Quarter Pounder, 7.38 ounce packages. Recall # F-1590-2011;
11) Race Trac, Ham Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-1591-2011;
12) Race Trac, American Sub, 10.17 ounce packages. Recall # F-1592-2011;
13) Race Trac, Tuna Salad 5.57 oz. packages. Recall # F-1593-2011;
14) Starbucks, Egg Salad Sandwich, 6.6 ounce packages. Recall # F-1594-2011;
15) Starbucks, Chicken Chipotle, 5.9 ounce package. Recall # F-1595-2011;
16) Starbucks, Tarragon Chicken Salad Sandwich, 7.5 ounce package. Recall # F-1596-2011;
17) Starbucks, Roma Tomato & Mozzarella, 5.0 ounce package. Recall # F-1597-2011;
18) Starbucks, Turkey and Swiss Sandwich, 6.4 ounce package. Recall # F-1598-2011;
19) Starbucks, Ham and Swiss, 5.5 ounce package. Recall # F-1599-2011;
20) Starbucks, Strawberry and Blueberry Yogurt Parfait, 8.1 ounce package. Recall # F-1600-2011;
21) Starbucks, Dark Cherry Yogurt Parfait, 8.1 ounce package. Recall # F-1601-2011;
22) Starbucks, Greek Yogurt & Honey Parfait, 6.1 ounce package. Recall # F-1602-2011;
23) Starbucks, Sesame Noodles Bistro Box, 8.3 ounce package. Recall # F-1603-2011;
24) Starbucks, Cheese & Fruit Bistro Box, 5.3 ounce package. Recall # F-1604-2011;
25) Starbucks, Protein Bistro Box, 6.8 ounce package. Recall # F-1605-2011;
26) Starbucks, Tuna Salad Plate Bistro Box, 5.9 ounce package. Recall # F-1606-2011;
27) Starbucks, Hot Panini Roasted Tomato & Mozzarella, 5.1 ounce. Recall # F-1607-2011;
28) Starbucks, Hot Panini Roasted Vegetable, 6.1 ounce package. Recall # F-1608-2011;
29) Starbucks, Hot Panini Chicken Santa Fe, 6.1 ounce package. Recall # F-1609-2011;
30) Starbucks, Hot Panini Ham & Swiss, 5.2 ounce package. Recall # F-1610-2011
CODE
1) and 2) Enjoy By dates of 7/23 - 8/3;
3), thru 13), Sell Thru dates of 7/17 -7/28;
14) thru 20) Enjoy By dates 7/15-7/26;
21), 22) Enjoy By dates 7/16-7/27;
23) thru 30) Enjoy By dates 7/15-7/26
RECALLING FIRM/MANUFACTURER
Flying Food Group, LLC, Lawrenceville, GA, by telephone and email on July 25, 2011, a press release was issued on July 27, 2011 and by follow up letter on July 28, 2011. Georgia initiated recall is ongoing.
REASON
Products were found to be contaminated with Listeria monocytogenes
VOLUME OF PRODUCT IN COMMERCE
38, 027 lbs
DISTRIBUTION
AL, FL GA
___________________________________
PRODUCT
Salted Smoked Split Herring; 18 lb. wooden box; Product of Canada. Recall # F-1611-2011
CODE
Lot #: 274 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Porky Products Inc., Carteret, NJ, by press release dated May 2, 2011 and by letter on May 3, 2011.
Manufacturer: Les Fumoirs Gaspe Cured Inc., Cap-D'Espoir, Canada. New York initiated recall is ongoing.
REASON
NYSDAM sampling revealed that Salted Smoked Split Herring (bloaters) may have the potential to be contaminated with Clostridium Botulinum since they are uneviscerated.
VOLUME OF PRODUCT IN COMMERCE
44 cases (18 lbs per case with approx 50 fish per case)
DISTRIBUTION
NY, NJ, MD, PA, NC, CT
___________________________________
PRODUCT
Cantaloupe for sale in bulk, in brown cardboard cartons each with the Kandy logo in white with the word 9 printed on the side of the carton. Each melon bears a Kandy sticker with the words 'Cantaloupe USA.' Sold between June 2 and June 17, 2011. UPC 098843040505. Recall # F-1612-2011
CODE
Lot No. PLF00310
RECALLING FIRM/MANUFACTURER
Maritori Farms, Scottsdale, AZ, by press release on June 24, 2011. FDA initiated recall is ongoing.
REASON
Cantaloupes has the potential to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,760 cartons, each containing 9 melons
DISTRIBUTION
NY, PA
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PRODUCT
f&e Organic Baby Spinach 5 oz.(142g) Plastic Bag; UPC/Barcode: 20001162. Recall # F-1615-2011
CODE
Lot Number or ID: S4 07:46, Code: By AUG 01 ONLY
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh And Easy, El Segundo, CA, by email and press release on August 5, 2011.
Manufacturer: Fresh & Easy Produce Campus, Riverside, CA. FDA initiated recall is ongoing.
REASON
The recall was initiated because Fresh & Easy Neighborhood Market Inc. has confirmed the fresh Organic Baby Spinach to be positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
6,848 units
DISTRIBUTION
CA. NV, AZ
___________________________________
PRODUCT
1) Incorrect Product Labeling for Winn-Dixie Lemon Bar Cake, UPC 0209983 105997; Bar Cake Lemon***Ingredients: High Fructose Corn Syrup, Partially Hydrogenated Palm Kernel Oil, Water, Contains Less Than 2% of the Following: Sodium Caseinate [A Milk Derivative], Natural and Artificial Flavor, Soy Protein Concentrate, Polysorbate 60, Sugar, Carbohydrategum, Salt Polyglycerol Esters of Fatty Acids, Soy Lecithin, to Preserve Freshness [Potassium Sorbate] Xanthangum, Artificial Color [Yellow 5, Red 40] Contains Milk, Soy - Not a Source of Lactose. Product is packaged in rectangular plastic clam shells. Note: Quantity of product manufactured and quantity distributed is unknown as each retail location produces product as needed. Recall #F-1618-2011;
2) Incorrect labeling for Winn Dixie Chocolate Cherry Bar Cake: Ingredients: Water, Vegetable Oil [Partially Hydrogenated Palm Kernel], Sugar, Dextrose, Fructose, Corn Syrup, Cocoa [Processed with Alkali], Sodiumcasenate [Milk], Potassium Sorbate [Preservative], Cellulose Gum, Polysorbate 60, Salt, Natural and Artificial Flavor, Polyglycerol Esters of Fatty Acids, Soy Leithin, Xanthangum, Sorbic Acid [Preservative]. Product is packaged in rectangular plastic clam shells. Note: Quantity manufactured and quantity distributed is unknown as each store produces the product as needed; UPC 0209831 105995. Recall # F-1619-2011
3) Incorrect labeling for Winn-Dixie Iced Cinnamon Roll, 6 Ct.: "Winn Dixie bakery Cinnamon Roll***Ingredients: Bleached Enriched Flour (Flour, Barley Malt Flour, Niacin, Iron, Thiamine Mononitrate, Riboflavin, Folic acid), Water, High Fructose Corn Syrup, Soybean Oil, Sugar, Yeast, Whey, Salt, Partially Hydrogenated Vegetable Oil (soybean and/or Cottonseed), Cinnamon, Vital Wheat Gluten, Datum, Corn Starch, Corn Flour, Mono & Diglycerides, Natural & Artificial Flavory, Cocoa Processed W/Alkali, Artificial Color, Ascorbic Acid, L-Cysteine Hydrochloride, Soylecithin, Propionic Acid (Preservative), Phosphoric Acid. Icing: Sugar, Water, Corn Syrup, Agar, Artificial Color, Potassium Sorbate (Preservative), Citric Acid, Natural & Artificial Flavor, Locust Bean Gum, Mono & Diglycerides. May contain Pecans, Walnuts, and Raisins. Sugar, Vegetable Oil, Water, High Fructose Corn Syrup, Corn Syrup, Whey (Milk) AltificiaL Color Including Red 40, Natural & Artificial Flavor, Mono and Diglycerides, Polysorbate 60, Salt, Soylecithin, Potassium Sorbate (Preservative) Citric Acid. Cream Cheese (Pasteurized Milk & Cream Cheese culture, Salt, Carob Bean Gum), Water, Sugar, Food Starch-Modified, Corn syrup, Potassium Sorbate and Benzoic acid and Sodium Propionate (as Preservatives), Salt, Lactic Acid, Titanium Dioxide (as Color), Gluconodelta Lactone, Propylene Glycol, Natural and Artificial Flavor, Polysorbate 80, Sodium Citrate, Gellangum, Glycerin, Yellow 5, Yellow 6, Caramel Color. Allergen (Milk). Net wt. 0lb 14oz (397g), UPC 0209806 602993 Iced Cinnamon Roll, 6 Ct product is packaged in either brown paper board boxes with a plastic window lid or in square aluminum pans with clear plastic lids. Note: Quantities manufactured and distributed are unknown as each store produces product on an as needed basis. Recall # F-1620-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Winn Dixie Stores, Inc., Jacksonville, FL, by email and visit on August 4, 2011 and by press release on August 5, 2011. FDA initiated recall is ongoing.
REASON
The products may be mislabeled. The mislabeled products may contain undeclared egg and/or wheat.
VOLUME OF PRODUCT IN COMMERCE
3,321 products
DISTRIBUTION
FL, GA, AL, TN, and MS
___________________________________
PRODUCT
1) Island Medley: 1) Garden Highway Fresh Fruit NO PRESERVATIVES PERISHABLE KEEP REFRIGERATED Island Medley Net Wt. 10 oz (284g); 2) 1 lb (454g) Island Medley PERISHABLE KEEP REFRIGERATED Ingredients: Pineapple, Mango, Papaya Packed in its own juice; 3) Island Medley 5 oz (142g) Ingredients: Pineapple, Mango, Papaya Packed in its own juice; UPC 8 26766 20900 2. Recall # F-1621-2011;
2) 16 oz (1 lb) Papaya Spears PERISHABLE KEEP REFRIGERATED Ingredients: Papaya. Packed in its own juice. UPC: 8 26766 26209 0. Recall # F-1622-2011;
3) 16 oz (1 lb) Tropical Medley, PERISHABLE KEEP REFRIGERATED. Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC: 8 26766 26114 7. Recall # F-1623-2011;
4) 11 oz (312g) Tropical Salsa PERISHABLE KEEP REFRIGERATED Ingredients: Mango, Papaya, Pineapple, Red Bell Pepper, Lime Juice, Red Onion, Cilantro, Jalapeno; UPC: 8 26766 26218 2. Recall # F-1624-2011
CODE
All codes with Best if sold by date of 07/30/11 or sooner.
RECALLING FIRM/MANUFACTURER
GH Foods Southwest LLC, Houston, TX, by telephone on July 25, 2011 and press release on July 27, 2011. Firm initiated recall is ongoing.
REASON
The products have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,021 cases
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
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PRODUCT
Organic Sunshine Patty - Falafel 2.67 oz Organic Falafel Vegetarian Patty Frozen product. Recall # F-1613-2011
CODE
Use by dates DEC 13 2011 to JUN 2 2012
RECALLING FIRM/MANUFACTURER
Sunshine Burger Corp., Bridgeville, DE, by email and letter on June 15, 2011. Firm initiated recall is ongoing.
REASON
Product contains organic split peas which were not listed in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
27,666 lbs
DISTRIBUTION
CA, CO, IL, MA, and NJ
___________________________________
PRODUCT
Golden Age Complete Liquid Formula, High Potency, Multivitamin, Multimineral, 8 fl oz (237mL), Rx Choice label, NDC 50383-786-08 (Barcode 3-50383-786-08-5). The product is also sold under the Rugby label as Advanced Formula Cerovite Liquid Multiple Vitamin/Mineral Liquid Supplement, 8 fl oz (237 mL), Barcode 0-0536-2790-59-0. Recall # F-1614-2011
CODE
Lot # 606547, exp. 07/2012
RECALLING FIRM/MANUFACTURER
Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone and letters dated March 9, 2011. Firm initiated recall is ongoing.
REASON
Presence of precipitate which was identified as undissolved biotin, a raw material present in the finished product formulation
VOLUME OF PRODUCT IN COMMERCE
45,864 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Cardboard carton containing four individually wrapped one-quarter pound sticks of butter and labeled in part: "rBGH-FREE Rose Valley***Unsalted Sweet Cream Butter Net Wt 1 lb (453g)*** AA Grade Unsalted***Keep Refrigerated***Ingredients: Pasteurized rBGH-free sweet cream; Contains Milk. Recall # F-1616-2011;
2) Cardboard carton containing four one-quarter pound sticks of butter and labeled in part: and Cardboard carton containing one 1-lb stick of butter "Rose Valley***Unsalted Sweet Cream Butter Organic Net Wt 1 lb (453g)***AA Grade Unsalted***Keep Refrigerated; Ingredients: Pasteurized organic sweet cream; Contains Milk. Recall # F-1617-2011
CODE
1) Lot number on carton: "41-25 CH 060-11 EXP 7/29/2011" Case code: "CH 060 BOX #### EXP 7/29/2011 41-25" Code Breakdown: 41-25 = plant number CH 060-11 = churn number (production date-julian date 3/1/2011;
2) Lot number on carton: "41-25 CH 119-11 EXP 9/26/2011" Case code: "CH 119 BOX #### EXP 9/26/2011 41-25". Code Breakdown: 41-25 = plant number CH 119-11 = churn number (production date-julian date 4/29/2011)
RECALLING FIRM/MANUFACTURER
Farmers Cooperative Creamery, McMinnville, OR, by e-mail and telephone on June 30, 2011. Oregon initiated recall is ongoing.
REASON
Product is adulterated; it contains mold.
VOLUME OF PRODUCT IN COMMERCE
5,000-5,010 lbs total (2,505 lbs & 2,315-2,325 lbs of the quarters & 180 lbs of the 1 lb blocks)
DISTRIBUTION
OR
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report7, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
PRODUCT
Polymyxin B for Injection USP, 500,000 Units per vial, NDC #55390-139-10
Vecuronium Bromide for Injection, 10 mg per vial, NDC #55390-037-10.
CODE
Lot #0977-00-1942980, Lot #0977-00-1895027, Lot #0905-04-1865067, Lot #0905-05-1865069
RECALLING FIRM/MANUFACTURING FIRM
Ben Venue Laboratories Inc, Bedford, Ohio
REASON FOR RECALL
Presence of Particulate Matter
PRODUCT
Esterified Estrogens and Methyltestosterone Tablets, USP, 1.25mg/2.5mg, NDC 53746-078-01
CODE
HB08111, HB26511
RECALLING FIRM/MANUFACTURING FIRM
Amneal Pharmaceuticals of New York, LLC, Hauppauge, NY
REASON FOR RECALL
Labeling: missing lot numbers and expiration dates
PRODUCT
Glipizide Tablets USP, 5 mg, Rx only, 1) 100 count bottle, NDC 0172-3649-60 2) Glipizide Tablets USP, 10 mg, Rx only 500 count bottle NDC # 0172-3650-70
CODE
BFA16A, BFA97A, BFA17A, BFH64A
RECALLING FIRM/MANUFACTURING FIRM
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA
Manufacturing Firm: Teva Pharmaceuticals Limited, Waterford, Ireland
REASON FOR RECALL
Impurities/Degradation Products, Out of specification impurity result
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) Jantoven (warfarin sodium), 3 mg, 100-count bottle, Rx only, NDC 0832-1214-00. Recall # D-800-2011;
2) Jantoven (warfarin sodium), 1 mg, 100-count bottle, Rx only, NDC 0832-1211-00. Recall # D-801-2011;
3) Jantoven (warfarin sodium), USP, 2 mg, 100-count bottle, Rx only, NDC 0832-1212-00. Recall # D-802-2011;
4) Jantoven (warfarin sodium), USP, 2.5 mg, 100-count bottle, Rx only, NDC 0832-1213-00. Recall # D-803-2011;
5) Jantoven (warfarin sodium), 4 mg, 100-count bottle, Rx only, NDC 0832-1215-00. Recall # D-804-2011;
6) Jantoven (warfarin sodium), 7.5 mg, 100-count bottle, Rx only, NDC 0832-1218-00. Recall # D-805-2011;
7) Jantoven (warfarin sodium), 5 mg, 100-count bottle, Rx only, NDC 0832-1216-00. Recall # D-806-2011;
8) Jantoven (warfarin sodium), 6 mg, 100-count bottle, Rx only, NDC 0832-1217-00. Recall # D-807-2011;
9) Jantoven (warfarin sodium), 10 mg, 100-count bottle, Rx only, NDC 0832-1219-00. Recall # D-808-2011;
10) Oxybutynin Chloride Tablets, 5 mg, 100-count bottle, Rx only, NDC 0832-0038-00. Recall # D-809-2011;
11) Bethanechol Chloride Tablets, 5 mg, 100-count bottle, Rx only, NDC 0832-0510-00. Recall # D-810-2011;
12) Bethanechol Chloride Tablets, 10 mg, 100-count bottle, Rx only, NDC 0832-0511-00. Recall # D-811-2011;
13) Bethanechol Chloride Tablets, 25 mg, 100-count bottle, Rx only, NDC 0832-0512-00. Recall # D-812-2011;
14) Baclofen Tablets, 10 mg, a) 90-count bottle (NDC 0832-1024-09), b) 100-count bottle (NDC 0832-1024-00), Rx only. Recall # D-813-2011;
15) Androxy (fluoxymesterone) Tablets, 10 mg, 100-count bottle, Rx only, NDC 0832-0086-00. Recall # D-814-2011;
16) Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, NDC 0832-0111-00. Recall # D-815-2011;
17) Amlodipine Besylate Tablets, 5 mg, 90-count bottle, Rx only, NDC 0832-0043-09. Recall # D-816-2011
CODE
1) Lot # 280612, Exp 06/12; 284081, Exp 09/12;
2) Lot # 280617, Exp 03/12; 282872, Exp 07/12;
3) Lot # 280598, Exp 06/12;
4) Lot # 281667, Exp 07/12;
5) Lot # 283334, Exp 07/12;
6) Lot # 280614, Exp 08/12;
7) Lot # 280581, 283455, Exp 06/12; 283340, Exp 07/12; 283459, Exp 09/12;
8) Lot # 282277, Exp 06/12; 284079, Exp 09/12;
9) Lot # 282917, Exp 02/12; 283342, Exp 08/12;
10) Lot # 283368, Exp 07/13;
11) Lot # 282255, Exp 08/12;
12) Lot # 280569, Exp 06/12;
13) Lot # 280567, Exp 06/12;
14) a) Lot # 284651, Exp 09/12; 282346, Exp 08/12; b) Lot # 281664, Exp 08/12;
15) Lot # 283336, Exp 09/12;
16) Lot # 280603, 283797, Exp 07/12; 284166, Exp 08/12;
17) Lot # 280564, Exp 05/12; 282661, Exp 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Upsher Smith Laboratories, Inc., Maple Grove, MN, by telephone on February 11, 2011, letters on February 15, 2011 and February 24, 2011 and by press release on February 16, 2011 and February 18, 2011.
Manufacturer: Upsher Smith Laboratories, Inc., Denver, CO. Firm initiated recall is ongoing.
REASON
Report of a bottle labeled as Jantoven (warfarin sodium) 3 mg tablets, Rx only, anticoagulant, actually contained Jantoven (warfarin sodium) 10 mg tablets. Recall expanded on 2/18/2011 to include additional products that were packaged on the same packaging line.
VOLUME OF PRODUCT IN COMMERCE
373,573 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Citalopram tablets, USP, 10 mg, 100-count bottles, Rx Only, Made in India, NDC 59762-4800-1. Recall # D-817-2011
CODE
Lot # FI0510058-A Exp 09/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., Peapack, NJ, by press release on March 26, 2011 and by letter on March 28, 2011.
Manufacturer: Aurobindo Pharma L, Andhra Pradesh, India. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-Up; Bottles of finasteride 5 mg tablets (90-count) have been found to be incorrectly labeled as citalopram 10 mg (100-count) tablets. The lot number, FI0510058-A, appears on both the citalopram 10 mg labels and the finasteride 5 mg labels.
VOLUME OF PRODUCT IN COMMERCE
720 bottles
DISTRIBUTION
TN, MI
___________________________________
PRODUCT
1) RockHard Weekend, Sexual Performance Enhancer for Men, sold 1 capsule per blister pack, UPC Number 094922147257; 3 count bottles, UPC Number 094922208705; and 8 count bottles, UPC Number 094922147240. Recall # D-818-2011;
2) Pandora, Sexual Enhancer for Women, 1 capsule per blister pack, UPC Number 094922014948. Recall # D-819-2011
CODE
1) Lot Number: 100159, Exp Date: 01/12 and Lot Number: 100260, Exp. Date: 03/12;
2) Lot Number: 100378, Exp Date: 03/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rock Hard Laboratories, LLC, Roswell, GA, by press release and letters on December 22, 2010.
Manufacturer: Protech Nutraceuticals Inc., Clearwater, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Laboratory analysis identified an analogue of Sildenafil, an ingredient in a FDA approved drug to treat Erectile Dysfunction in the products. That makes the products unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
1,600,000 capsules both types
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 5 mL single dose vial, Rx only, Made in India; Product 109305, NDC 63323-193-05, UPC 3 63323-193-05 8. Recall # D-820-2011
CODE
Lot 870DE00301, Exp 06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: App Pharmaceuticals LLC, Schaumburg, IL, by letters dated February 24, 2011 and March 25, 2011.
Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.
REASON
Non-sterility (fungus) Penicillin Citreonigrum.
VOLUME OF PRODUCT IN COMMERCE
81,432 - 5 mL vials
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Svelte 30 Capsules, 30 count bottles, UPC 04-3000 - 04-5999. Recall # D-823-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Svelte 30, Kissimmee, FL, by a press release dated February 9, 2011.
Manufacturer: Hainan Resurgence Natural Healthy F, Guangzhou City, China. FDA initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA; product found to contain sibutramine.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Extenze Nutritional Supplement Tablets packaged in 4 count blister cards and 2x15 count blister cards. Recall # D-826-2011
CODE
Lot Numbers: 0709241 and 0509075
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biotab Nutraceuticals Inc., Monrovia, CA, by press release on February 22, 2011 and letters beginning February 23, 2011.
Manufacturer: Biotab Nutraceuticals, Inc., Chatsworth, CA. FDA initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA: some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared tadalafil, sildenafil and sibutramine
VOLUME OF PRODUCT IN COMMERCE
26,511retail units (10,257 x 4 ct & 16,254 x 30 ct)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Thyro-Tab (levothyroxine sodium, USP) tablets, 0.175 mg, bulk drums intended for repackaging, Rx only. Recall # D-775-2011;
2) Levothroid (levothyroxine sodium, USP) tablets, 175 mcg, 100-count bottles, Rx only; NDC 0456-1326-01; UPC 3 04561 32601 3. Recall # D-776-2011
CODE
1) Lot HA31409, Exp 05/11;
2) Lot 1071287, Exp 05/11
RECALLING FIRM/MANUFACTURER
Lloyd Inc Of Iowa, Shenandoah, IA, by letters dated October 25, 2010 and November 12, 2010. Firm initiated recall is complete.
REASON
Subpotent (Single Ingredient) Drug: The product had low assay testing at the 9-month stability time point.
VOLUME OF PRODUCT IN COMMERCE
Thyro-Tab - 1,922,036 bulk tablets; Levothroid - 19,142 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Levoxyl (levothyroxine sodium, USP) tablets, 75 mcg, 100-count bottle, Rx only; NDC 60793-852-01; UPC 3 60793-852-01 0. Recall # D-778-2011
CODE
Lot #: 74476, Exp 03/12
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN, by e-mail and telephone on July 14, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: The firm repacked Levoxyl Tablets, USP, 75 mcg Lot #60809 which has been recalled by King Pharmaceuticals. King Pharmaceuticals received a complaint of a single 200 mcg Levoxyl Tablet co-mingled in a 1000-count bottle of Levoxyl Tablets, USP 75 mcg.
VOLUME OF PRODUCT IN COMMERCE
1,009 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ONCASPAR (pegaspargase) (PEG-L-asparaginase) injection, 750 I.U. per mL, 5 mL single-dose vial, Rx only, NDC 57665-002-02; UPC 3 57665-00202 4; Product Code V-002-21-US-C. Recall # D-779-2011
CODE
Lot 0090A, Exp 08/28/11
RECALLING FIRM/MANUFACTURER
Sigma-Tau Pharmasource, Inc., Indianapolis, IN, by letters on July 29, 2011. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient) Drug: Review of the stability data indicates results of 906 IU/rnL for potency (activity) (specification 600-900 IU/mL), prior to the indicated expiration date.
VOLUME OF PRODUCT IN COMMERCE
2,190 vials
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT
1) GUNA biotherapeutics/GUNA(R)-COLLAGEN Homeopathic medicine. Recall # D-780-201;
2) GUNA biotherapeutics/GUNA(R)-HANDFOOT Homeopathic medicine. Recall # D-781-2011;
3) GUNA biotherapeutics/GUNA(R)-HIP Homeopathic medicine. Recall # D-782-2011;
4) GUNA biotherapeutics/GUNA(R)-ISCHIAL Homeopathic medicine. Recall # D-783-2011;
5) GUNA biotherapeutics/GUNA(R)-LUMBAR Homeopathic medicine. Recall # D-784-2011;
6) GUNA biotherapeutics/GUNA(R)-MUSCLE Homeopathic medicine. Recall # D-785-2011;
7) GUNA biotherapeutics/GUNA(R)-NECK Homeopathic medicine. Recall # D-786-2011;
8) GUNA biotherapeutics/GUNA(R)-NEURAL Homeopathic medicine. Recall # D-787-2011;
9) GUNA biotherapeutics/GUNA(R)-POLYARTHRITIS Homeopathic medicine. Recall # D-788-2011;
10) GUNA biotherapeutics/GUNA(R)-SHOULDER Homeopathic medicine. Recall # D-789-2011;
11) GUNA biotherapeutics/GUNA(R)-THORACIC Homeopathic medicine. Recall # D-790-2011;
12) GUNA biotherapeutics/GUNA(R)-MADE Homeopathic medicine. Recall # D-791-2011;
13) GUNA biotherapeutics/OMEOFORMULA Homeopathic medicine/1 ADIPOSITY. Recall # D-792-2011;
14) GUNA biotherapeutics/OMEOFORMULA Homeopathic medicine/2 CELLULITE. Recall # D-793-2011;
15) GUNA biotherapeutics/OMEOFORMULA Homeopathic medicine/3 TISSUE TONE. Recall # D-794-2011;
16) GUNA biotherapeutics/OMEOFORMULA Homeopathic medicine/4 BREAST. Recall # D-795-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guna S.p.A., Milano, Italy, by email, telephone and letters beginning November 15, 2010.
Manufacturer: Jenahexal Pharm Gmbh, Jena, Germany. Firm initiated recall is ongoing.
REASON
CGMP Deviations: FDA inspection at manufacturer revealed cGMP deviations.
VOLUME OF PRODUCT IN COMMERCE
1,059,260 amplules
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Calcium Gluconate Injection, USP, 10%, 46.5 mEq/100 mL Calcium, 100 mL 100 mL Pharmacy Bulk Package Not For Direct Infusion, Rx Only, For Intravenous Use, NDC 0517-3900-25. Recall # D-796-2011
CODE
Lot 1006, exp. 1/2013
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc. Shirley, NY, by press release on July 18, 2011. Firm initiated recall is ongoing.
REASON
Presence of particulate matter; Visual particulate matter was observed in retain sample and vials.
VOLUME OF PRODUCT IN COMMERCE
34,550 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Vasopressin Injection, USP, Synthetic, 20 Units/mL (200 Units/10 mL), 10 X 10 mL Multiple Dose Vials, For IM or SC Use Only, Rx Only, NDC 0517-0410-10. Recall # D-797-2011;
2) Vasopressin Injection, USP, Synthetic, 10 Units/0.5 mL, 25 X 0.5 mL Multiple Dose Vials, For IM or SC Use Only, Rx Only, NDC 0517-0510-25. Recall # D-798-2011;
3) Vasopressin Injection, USP, Synthetic, 20 Units/1 mL, 25 X 1 mL Multiple Dose Vials, For IM or SC Use Only, Rx Only, NDC 0517-1020-25. Recall # D-799-2011
CODE
1) Lot #: a) 9677, 0294, Exp 10/11; 0442, Exp 12/11; 0052, Exp 01/12; 0663, Exp 4/12;
2) Lot #: 0103, Exp 02/12;
3) Lot #: 9532, Exp 08/11; 9618, Exp 09/11; 9707, 0273, Exp 10/11; 0346, Exp 11/11; 0400, 0437, Exp 12/11; 0104, 0124, Exp 02/12; 0618, Exp 03/12; 0758, Exp 05/12
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letters dated August 2, 2011 and press release on August 3, 2011. Firm initiated recall is ongoing.
REASON
Sub-Potent (Single Drug Ingredient): Out of Specification results for assays.
VOLUME OF PRODUCT IN COMMERCE
2,584,990 Multiple Dose Vials
DISTRIBUTION
Nationwide, Puerto Rico, Guam, Colombia, Saudi Arabia, and Abu Dhabi (United Arab Emirates)
___________________________________
PRODUCT
1) Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 5 mL single dose vial, Rx only, Made in India; Product 109305, NDC 63323-193-05, UPC 3 63323-193-05 8. Recall # D-821-2011;
2) Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 2 mL single dose vial, Rx only, Made in India; Product 109302, NDC 63323-193-02, UPC 3 63323-193-02 8. Recall # D-822-2011
CODE
1) Lot 870DE00101, Exp 06/2012; Lot 870DE00201, Exp 06/2012, Lot 870DE00401, Exp 06/2012;
2) Lot 870DE00101, Exp 06/2012; Lot 870DE00201, Exp 06/2012, Lot 870DE00401, Exp 06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: App Pharmaceuticals LLC, Schaumburg, IL, by letters dated February 24, 2011 and March 25, 2011.
Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
81,432 - 5 mL vials, 192 - 2mL vials
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Metoprolol Tartrate Tablets, USP, 100 mg, Rx Only, a) 100-count bottle, NDC 0904-6034-60, 1000-count bottle, NDC 0904-6034-80. Recall # D-824-2011;
2) Metoprolol Tartrate Tablets, USP, 50 mg, Rx Only, a) 100-count bottle, NDC 0904-6033-60, 1000-count bottle, NDC 0904-6033-80. Recall # D-825-2011
CODE
1) Lots L-1980 (100-ct.) and L-1980A (1,000-ct.), Exp 06/12;
2) Lots L-1979 (100-ct.) and L-1979A (1,000-ct.), Exp 06/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legacy Pharmaceutical Packaging LLC, Earth City, MO, by letter dated January 5, 2011.
Manufacturers: Sandoz, Inc., Broomfield, CO;
Legacy Pharmaceutical Packaging LLC, Earth City, MO. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements: Individual tablets may be outside of specification for content uniformity.
VOLUME OF PRODUCT IN COMMERCE
1) 3,524 bottles; 2) 4920 bottles
DISTRIBUTION
MI
___________________________________
PRODUCT
Procardia XL (Nifedipine) Extended Release Tablets 30 mg, Rx only, a) 100 count, NDC 0069-2650-66 and b) 300 count bottles, NDC 0069-2650-72. Recall # D-827-2011
CODE
a) Lot # V110327 Exp date: August 2015; b) Lot # V110314 Exp date: August 2015
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on April 28, 2011.
Manufacturer: Pfizer Pharmaceuticals LLC, Vega Baja, PR. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification.
VOLUME OF PRODUCT IN COMMERCE
a) 409 bottles; b) 354 bottles
DISTRIBUTION
AL, AZ, CA, FL, GA, IL, KY, MO, NC, NJ, NY, OH, PA, TN, and TX
___________________________________
PRODUCT
Advil Congestion Relief Tablets, 200 mg Ibuprofen/10 mg Phenylephrine Hydrochloride USP, packaged 10 tablets on 1 blister card (NDC : 0573-0195-10), packaged in 50 tablet Pouch Dispenser, 1 tablet/pouch (NDC: 0573-0195-01). Recall # D-830-2011
CODE
E80793, exp 02/13; E80796, exp 02/13; E80805, exp 02/13; E97790, exp 02/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division Of Wyeth LLC, A Subsidiary Of Pfizer Inc., Richmond, VA, by letter on February 16, 2011.
Manufacturers: Richmond Division Of Wyeth LLC, A Subsidiary Of Pfizer Inc., Richmond, VA;
Pfizer Pharmaceuticals LLC, Vega Baja, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: OTC product failed to meet dissolution specifications for ibuprofen and phenylephrine hydrochloride.
VOLUME OF PRODUCT IN COMMERCE
316,056 units, 912 dispensers (50 pouches, 1 tablet/pouch)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Aquafresh Fluoride Toothpaste Triple Protection, 2 Tubes-Net Wt 8.2 oz (232.4g) each; (L)0K0; Case UPC 00053100333523; SKU Number: 33352A; Retail UPC 053100333493. Recall # D-777-2011
CODE
Shipping Lot #'s: 0K08C15 and 0K08D15; Shipping Case Exp Date: November 2012; Twin Pack Lot #: 0K08; Twin Pack Expiration Date: 11-2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Consumer Healthcare LP, Parsippany, NJ, by letter on April 11, 2011.
Manufacturer: GlaxoSmithKline Consumer Healthcare, LP, Clifton, NJ. Firm initiated recall is ongoing.
REASON
Incorrect product formulation; OTC toothpaste contain bubble gum flavoring instead of mint flavoring.
VOLUME OF PRODUCT IN COMMERCE
5,751 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1599-11;
2) Recovered Plasma. Recall # B-1600-11
CODE
1) and 2) Units: W117008107872, 5332010
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by facsimile and telephone on October 1, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1601-11
CODE
Unit: FM77068 (2 units)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 26, 2006. Firm initiated recall is complete.
REASON
Blood products, for which the documentation of irradiation was discrepant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1603-11
CODE
Units: 0100560978, 0100557044, 0100556780, 0100556471, 0100556316, 0100556056, 0100555888, 0100555542, 0100555414, 0100555114, 0100554930, 0100554657, 0100554147, 0100553762, 0100553560, 0100552601, 0100552146, 0100551532, 0100551366, 0100550926, 0100550457, 0100549831, 0100560537, 0100560126, 0100559903, 0100559753, 0100559246, 0100559070, 0100557523
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc., Chattanooga, TN, by facsimile on July 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
NC, Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1714-11
CODE
Unit: W128709120297
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and follow-up letter on June 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1757-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1758-11;
CODE
Unit: 017FE47962; 017FE47978; 017FE47978; 017FE47985; 017FE47985; 017FE47985; 017FE47993; 017FE47993; 017FE47997; 017FE48001; 017FE48001; 017FE48007; 017FE48007; 017FE48011; 017FE48011; 017FE48016; 017FE48016; 017FE48016; 017FE48027; 017FE48027; 017FE48030; 017FE48047; 017FE48047; 017FE48052; 017FE48052; 017FE48061; 017FE48061; 017FE48061; 017FE48076; 017FE48076; 017FE48091; 017FE48091; 017FE48091; 017FE48100; 017FE48100; 017FE48111; 017FE48111; 017FE48139; 017FE48139; 017FE48139; 017FE48182; 017FE48182; 017FE48208; 017FE48223; 017FE48223; 017FE48231; 017FE48312; 017FE48394; 017FE48394; 017FE48394; 017FE48407; 017FE48407; 017FE48407; 017FE48412; 017FE48412; 017FE48412; 017FE48421; 017FE48425; 017FE48425; 017FE48425; 017FE48434; 017FE48464; 017FE48464; 017FE48464; 017FE48475; 017FE48485; 017FE48485; 017FE48492; 017FE48531; 017FE48531; 017FE48540; 017FE48540; 017FE48437; 017FE48440; 017FE48440; 017FE48471; 017FE48471; 017FE48487; 017FE48528; 017FE48528; 017FE48537; 017FE48537;
2) Units; 017FE47958; 017FE48396; 017FE47946; 017FE47962; 017FE47974; 017FE47978; 017FE48007; 017FE48056; 017FE48056; 017FE48159 017FE48159; 017FE48159; 017FE48195; 017FE48195; 017FE48237; 017FE48312; 017FE48312; 017FE48421; 017FE48434; 017FE48450; 017FE48510; 017FE48540; 017FE48437; 017FE48447; 017FE48447; 017FE48460; 017FE48460; 017FE48460; 017FE48487; 017FE48487; 017FE48495; 017FE48495; 017FE48495; 017FE48496; 017FE48508; 017FE48528; 017FE48527
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on September 23, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the QC requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
MN, IL, WI, PA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1829-11;
2) Red Blood Cells. Recall # B-1830-11;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1831-11;
4) Plasma Frozen Within 24 Hours After Phlebotomy (FP24). Recall # B-1833-11
CODE
1) Units: 13FK76090; 13FR07915; 13GP53723; 13GP58583; 13GS73783; 13GW89327; 13KV16558;
2) Units: 13E12366; 13E19533; 13E20521;
3) Units: 13FK76090; 13FR07915; 13GP53723; 13GP58583; 13GS73783; 13KV16558;
4) Unit: 13GW89327
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Detroit, MI, by fax and letter on December 10, 2010 and follow up letter on January 10, 2011.
Manufacturer: American Red Cross, Southeastern Michigan Region, Detroit, MI. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1850-11
CODE
Unit: 6101522
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center,inc-cellular Therapy Laboratory, New York, NY, by letter on November 1, 2006.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-1851-11
CODE
Units: 4070037358, 4070036589, 4070036359, 4070035853, 4070035571, 4070035109, 4070034807, 4070034237, 4070033981
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc., Chattanooga, TN, by facsimile on April 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1863-11
CODE
Units: 7010383807; 7010383550; 7010374959; 7010374633; 7010373876; 7010373679;
7010385736
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Abilene, TX, by fax on October 2, 2007.
Manufacturer: Csl Plasma, Inc., Abilene, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
IN, NC
___________________________________
PRODUCT
Platelets. Recall # B-1864-11
CODE
Unit: W035208108704D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on October 16, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Platelets. Recall # B-1865-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1866-11
CODE
1) Units: W044608403940; W044608519013; W044608576292; W044608417186; W044608594852; W044608599626;
7) Unit: W044608588369
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on November 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors who had taken Aspirin within 48 hours of donation but not labeled as containing Aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1867-11
CODE
Unit: 9078065
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on August 20, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
eQue Software: An e-Interview (electronic donor health questionnaire) for the Standalone Blood Bank System. Recall # B-1868-11
CODE
Software versions: 1.3.0, 1.3.1, 1.3.2
RECALLING FIRM/MANUFACTURER
5D Information Management, Alberta, Canada by letter dated July 11, 2011. Firm initiated recall is ongoing.
REASON
Software, which may incorrectly present donors with an abbreviated donor screening questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA, FL, NJ, NC
___________________________________
PRODUCT
Human Cornea Tissue. Recall # B-1869-11
CODE
Units: 080162100, 080162200
RECALLING FIRM/MANUFACTURER
The Lions Eye Bank of Wisconsin, Inc., Madison, WI, by letter dated May 12, 2008. Firm initiated recall is complete.
REASON
Human Corneas for transplant, recovered from a donor with risk factors for communicable disease transmission (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1870-11
CODE
Unit: 016GE10480 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by facsimile on April 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Blood Bank Computer Service (BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M. The device is a software application used by blood banking firms to track donor information at remote sites to eventually link up with the Primary Application that is linked to the interactive database. Each customer has received three CDs due to software updates, and each CD containing different Serial number. The software CD is labeled in parts: "Blood Bank Control System (Primary Application) Release 5.3.8. Recall # B-1872-11
CODE
Serial Numbers: BBCS50M0113, BBCS50M0102, 0000905, 0001150, BBCS50M0126, BBCS50M0119, BBCS50M0110, BBCS50M0129, BBCS50M0127, BBCS50M0123, BBCS50M0104, BBCS50M0121, BBCS50M0118, BBCS50M0109, BBCS50M0107, BBCS50M0116, BBCS50M0125, BBCS50M0117, BBCS50M0128 , BBCS50M0120, 0000611, BBCS50M0103, BBCS50M0112, BBCS50M0101, BBCS50M0111, BBCS50M0105, BBCS50M0114, BBCS50M0108, BBCS50M0115, BBCS50M0106, 0000906, 0000516, BBCS50M0124, BBCS50M0122, 0000674, 0000675, 0000885, 0001151, 0000697, 0000676, 0000677, 0000698, 0000699, 0000700, 0000678, 0000679, 0000680, 0000681, 0000682, 0000683, 0000701, 0000684, 0000702, 0000685, 0000843, 0000687, 0000688, 0000689, 0000690, 0000691, 0000692, 0000693, 0000694, 0000695, 0000886, 0000822, 0000703, 0000696, 0001385, 0001386, 0001387, 0001389, 0001390, 0001391, 0001392, 0001393, 0001394, 0001395, 0001396, 0001397, 0001398, 0001399, 0001400, 0001401, 0001402, 0001403, 0001404, 0001405, 0001406, 0001407, 0001408, 0001409, 0001410, 0001411, 0001412, 0001413, 0001414, 0001415, 0001416, 0001388, 0001417, 0001418
RECALLING FIRM/MANUFACTURER
Blood Bank Computer Systems, Inc., Auburn, WA, by e-mail dated September 13, 2010. Firm initiated recall is ongoing.
REASON
(BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M, with a software glitch or defect, were distributed.
VOLUME OF PRODUCT IN COMMERCE
102 CDs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1874-11;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1876-11
CODE
1) Unit: W04251005217400U;
2) Units: W04251006680500F; W04251006680500F; W04251005216700S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone or electronic notification on October 27 and 29, 2010.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
SD, ND and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1877-11
CODE
Units: W117008123902, W117008103259
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by letter on October 22, 2008.
Manufacturer: Marin Center, San Rafael, CA. Firm initiated recall is complete.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1882-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1883-11
CODE
1) and 2) Unit: 017GW48783
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone and fax on March 31, 2011. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air during collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, MN
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-1884-11
CODE
Unit: 35S85443
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by letter on May 6, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1891-11
CODE
Unit: W270110529819
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by facsimile on May 25, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1598-11;
CODE
Units: W117008130328, W117008130333
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and facsimile on September 12, 2008 and September 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected using expired blood collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1832-11
CODE
Units: 13FK76090; 13FR07915; 13GP53723; 13GP58583; 13GS73783; 13KV16558
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Detroit, MI, by fax and letter on December 10, 2010 and follow up letter on January 10, 2011.
Manufacturer: American Red Cross, Southeastern Michigan Region, Detroit, MI. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1871-11
CODE
Unit: W036211235646
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 14, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was documented incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Six bone allografts from donors 084791 and 084538. Fresh Aseptic, Part Codes: 32147001, 32147002, 32247001, 32647001, 34647002. Recall # B-1873-11
CODE
Units: 084791003, 084791004, 084538001, 084538003, 084538004, 084538006
RECALLING FIRM/MANUFACTURER
Allosource, Centennial, CO, by letter on May 13, 2010. Firm initiated recall is complete.
REASON
Human tissue allografts, recovered from a donor whose serological testing was performed with expired reagents using Hepatitis B Virus Core Antigen (Recombinant) EIA assay, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 allografts
DISTRIBUTION
CA, CO, NJ, PA, WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1875-11
CODE
Units: W04251006682100F; W042510066819003; W042510066818005; W04251006681500B; W04251006681300F; W04251006681000L; W042510066809007; W04251006680600D; W04251006664009; W04251006666300B; W04251006666000H; W04251006665100J; W0425100666500F; W042510066649007; W04251006664700B; W04251006663800D; W04251006662600L; W04251006662300R; W04251005219500K; W04251005219400M; W04251005219300O; W04251005217400U; W04251005217200Y; W04251005217100*; W042510016800Q; W04251005216600U; W04251005218200U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone or electronic notification on October 27 and 29, 2010.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
SD, ND and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1878-11
CODE
Units: LR09294, GG34574, LM17920, LR03891
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone and facsimile on December 18 and 19, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1881-11
CODE
Unit: 36FW18354
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by electronic mail on May 6, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT). Recall # Z-2609-2011
CODE
Serial: 001YF024 004YF005 004YF019 004YF05C 004YF058 004YF081 004YF082 004YF084 005YF068 006YF075 008YF057 013YF04E 016YF02A 016YF049 016YF055 016YF058 017YF014 018YF00C 018YF01F 021YF03B 021YF031 021YF048 022YF01B 022YF02F 022YF03B 022YF031 022YF037 022YF043 022YF05A 022YF058 022YF067 023YF0B1 023YF016 023YF03F 023YF04C 023YF045 023YF089 023YF104 023YF12A 023YF129 023YF162 023YF173 024YF005 024YF034 025YF0B0 025YF0B4 025YF0C1 025YF0F2 025YF0F8 025YF06B 025YF07E 025YF08E 025YF094 025YF096 025YF117 026YF0BD 026YF0B0 026YF0E4 026YF02F 026YF028 026YF033 026YF06D 026YF068 026YF08F 028YF007 028YF01A 028YF01F 029YF001 029YF016 029YF03E 029YF05C 029YF1B5 029YF1DF 029YF11E 029YF15D 029YF204 030YF0E9 030YF004 030YF03F 030YF030 030YF061 030YF073 030YF1C2 030YF131 030YF139 030YF145 030YF152 030YF155 030YF16F 031YF039 032YF005 034YF011 034YF014 034YF016 034YF018 034YF024 037YF085 038YF065 041YF057 904YF033 932YF013 935YF010 936YF076 945YF024 003YG06D 004YG00D 004YG003 004YG012 004YG017 004YG03E 004YG031 004YG04F 004YG042 004YG043 004YG05A 004YG05D 004YG053 004YG056 004YG06F 004YG063 004YG064 004YG07E 004YG075 005YG00A 005YG048 005YG06B 005YG070 005YG074 005YG08F 006YG089 008YG03F 014YG03E 014YG092 015YG07B 016YG023 016YG026 016YG029 016YG04A 016YG04C 016YG05C 017YG00F 017YG03A 017YG050 018YG00F 018YG059 019YG032 020YG00D 020YG00F 020YG001 020YG01B 020YG017 020YG020 020YG026 020YG027 020YG03A 020YG035 021YG01E 021YG04C 021YG041 022YG026 022YG044 022YG069 023YG0B2 023YG0B3 023YG0C0 023YG01A 023YG086 023YG094 023YG101 023YG108 023YG137 023YG14D 023YG148 023YG16A 023YG16B 023YG160 023YG17A 024YG025 024YG044 024YG064 024YG07A 024YG08E 024YG08F 025YG0A3 025YG0A6 025YG05C 025YG064 025YG080 025YG095 025YG113 025YG119 026YG0A5 026YG0A9 026YG0B2 026YG0D1 026YG03C 026YG035 026YG036 026YG037 026YG038 026YG071 026YG08C 026YG090 026YG096 026YG098 026YG112 028YG037 029YG0C7 029YG0DA 029YG02A 029YG079 029YG08D 029YG1AD 029YG12A 029YG12C 029YG169 029YG178 029YG19A 030YG0AB 030YG0A0 030YG0BD 030YG0B7 030YG0EB 030YG0E2 030YG0E8 030YG0F0 030YG0F6 030YG039 030YG063 030YG1AC 030YG11F 030YG13C 030YG134 030YG14A 030YG14F 030YG141 030YG144 030YG149 030YG160 030YG17A 030YG195 031YG01C 031YG01D 031YG02D 031YG055 032YG0C9 032YG001 032YG003 032YG017 032YG029 032YG033 032YG035 032YG036 032YG054 032YG058 032YG067 032YG081 034YG00A 034YG00D 034YG03D 034YG041 034YG046 034YG051 037YG0B7 037YG0CC 037YG0D0 037YG067 041YG05D 835YG073 923YG037 925YG006 933YG0B9 944YG005 945YG005 947YG005
RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical Llc, Plymouth, MN, by telephone on April 27, 2011 and letter dated May 2, 2011.
Manufacturer: Sorin C.R.M., srl, Saluggia, VC, Italy. Firm initiated recall is ongoing.
REASON
The devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error.
VOLUME OF PRODUCT IN COMMERCE
275 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) PERPOS PLS SYSTEM, Catalog No. 9045-01 A sterile, medical device kit. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided and other labeling, including instructions for use. Recall # Z-2718-2011;
2) PERPOS PLS SYSTEM, Catalog No. 9045-02 A sterile, medical device kit. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided and other labeling, including instructions for use. Recall # Z-2719-2011
CODE
1) Lot #'s: 040309-A, 041409-A;
2) Lot #'s: 040209-B, 041309-B
RECALLING FIRM/MANUFACTURER
Interventional Spine Inc., Irvine, CA, by letter dated March 23, 2011. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw implant.
VOLUME OF PRODUCT IN COMMERCE
864 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO STERILE; Model numbers: a) 508-00-000 and b) 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles is necessary to use the device. Recall # Z-2739-2011
CODE
a) Lot #s: 848C1078, 848C1079, 848C1080, 848C1081, 848C1082, 848C1083, 848C1084, 848C1085, 848C1086, 848C1087; b) lot #'s: 854C1016
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letter dated April 18, 2011. Firm initiated recall is ongoing.
REASON
The device has the potential to not appropriately mate with the humeral stem.
VOLUME OF PRODUCT IN COMMERCE
81 units
DISTRIBUTION
Nationwide and Germany, Italy, and United Kingdom
___________________________________
PRODUCT
VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting. Recall # Z-2854-2011
CODE
Lot #s: 0XK, 0YK, 09K
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone on June 10, 2010. Firm initiated recall is complete.
REASON
Teumo's investigation identified issues with the devices’ capability to maintain pressure within the tunnel.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. Catalog/Model/Reorder Number: LGB. Recall # Z-2856-2011
CODE
Lot # 10-405
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pall Corp., Port Washington, NY, by letter dated May 26, 2011.
Manufacturer: Pall Newquay Ltd., Cornwall, United Kingdom. Firm initiated recall is ongoing.
REASON
Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA). Recall # Z-2858-2011
CODE
Lot 101028, exp 2013 - 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Medical Corp., Elkton, MD, by letter dated June 3, 2011.
Manufacturer: Ashitaka Factory of Terumo Corp., Fujinomiya City, Shizouka, Japan. Firm initiated recall is complete.
REASON
Baloon catheter guidewires may become uncoiled during angioplasty procedures.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. Recall # Z-2859-2011
CODE
Lot number: 0253304
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Cincinnati, OH, by letter dated May 20, 2011. Firm initiated recall is ongoing.
REASON
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
VOLUME OF PRODUCT IN COMMERCE
220 cases/50 units
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT
MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures. Recall # Z-2866-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Medrad Inc., Indianola, PA, by letter on June 2, 2011. Firm initiated recall is ongoing.
REASON
Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embolism risks. Firm has initiated Field Corrections to upgrade existing systems.
VOLUME OF PRODUCT IN COMMERCE
842 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Aplio Artida Ultrasound Diagnostic System SSH-880CV. A diagnostic ultrasound system. Recall # Z-2897-2011
CODE
Last 4 of Serial number: 2342, 2480, 2073, 2120, 2219, 2270, 2271, 2268, 2389, 2390, 2297, 2206, 2033, 2107, 2087, 2311, 2281, 2273, 2340, 2341, 2313, 2272, 2070, 2335, 2347, 2348, 2360, 2361, 2048, 2280, 2031, 2088, 2076, 2077, 2105, 2334, 2220, 2260, 2205, 2072, 2074, 2079, 2218, 2103, 2262, 2069, 2106, 2119, 2124, 2204, 2405, 2104, 2032, 2075, 2080, 2108, 2261, 2312, 2078, 2071, 2123, 2296, 2282, 2049, and 2056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated December 21, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
The panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, etc).
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. Recall # Z-2928-2011;
2) remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. Recall # Z-2929-2011
CODE
1) Lot 014360, Exp. 2011.04.18; Lot 020424, Exp. 2011.04.26; and Lot 025985, Exp. 2011.05.09;
2) Lot 017075, Exp. 2011.04.18; lot 018116, Exp. 2011.04.21; Lot 020358, Exp. 2011.04.27; lot 023750, Exp. 2011.05.04; and lot 023851, Exp. 2011.05.05
RECALLING FIRM/MANUFACTURER
Remel Inc, Lenexa, KS, by letters dated April 20, 2011 and April 25, 2011. Firm initiated recall is ongoing.
REASON
Organism strains may fail to consistently produce confluent growth.
VOLUME OF PRODUCT IN COMMERCE
761/10-pack boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 40 mm, 30 degree angle probe product number: GM11006140. Recall # Z-2995-2011
2) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 60 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 60 mm, 30 degree angle probe product number: GM11006160. Recall # Z-2996-2011;
3) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 80 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 80 mm, 30 degree angle probe product number: GM11006180. Recall # Z-2997-2011
4) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 30 mm, 30 degree angle probe product number: GM11006130. Recall # Z-2998-2011;
5) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 50 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 50 mm, 30 degree angle probe product number: GM11006150. Recall # Z-2999-2011
6) Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. To treat cancer of the uterus, cervix, endometrium and vagina. Product number applicator Set: GM11006200; 70 mm, 30 degree angle probe product number: GM11006170. Recall # Z-3000-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated July 13, 2011. Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.
REASON
Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
VOLUME OF PRODUCT IN COMMERCE
437 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate. The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the Officemate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: "Officemate has one small monitor” FSIII has two larger monitors” FSIIIc is an international version of the FSIII (power kit). Recall # Z-3015-2011
CODE
Serial Numbers: Office Mate: 02089805 02109804 02109903 02089810 02079802 09971484 05039816 05119832 02-0103-03 02080007 02129812 06971402 02119912 05039824 05129914 05079811 02079901 02059910 02129905 02069932 10971491 02-0104-01 02039805 02049920 02-0103-01 02-1202-03 02109806 09971460 11971502 02-0204-01 02-0304-01 02-0903-01 02059814 03-0602-04 06-0301-01 02109809 12971511 02-1103-01 02119814 02049809 02049803 02-1103-02 06971416 02040004 02-0803-01 02099817 02-0698-01 02070007 02069902 02090002 02039820 02069808 10971496 02-0603-04 02030123 02110014 07971423 12971509 09971463 02019806 09971465 02120201 05010003 05039833 05039834 05079805 05079808 05079809 05079816 05129916 05129917 05129918 05129921 05129922 05129923 05129924 05129930 05129931 05129932 07971435 08971437 08971442 08971444 08971445 08971446 06971401 05079814 09971471 02059914 02110003 09971485 07971419 05010111 05-0101-11 02039925 05079813 02039922 02040009 02109807 05129813 02040106 02039803 02089804 09971462 05129919 07971421 02109812 04971800 02030013 05079807 02109821 02049816 02-0303-02 02100018 02020008 02089913 02019913 05079806 02010218 02039813 09971474 02100008 10971495 05039832 02-0403-01 06971415 02-0404-01 02-0505-01 07971424 05079817 02069810 02119810 02-1202-01 08-9714-38 05039826 05039827 05039830 05039831 05079804 08971441 08971443 02019903 02100005 02129803 02-0603-03 02079815 02079820 02099806 02-1203-01 02050003 02109805 02129904 10971492 02-0603-01 02010007 02-0602-01 02039902 02119801 02040129 02109813 02089807 FSIII: 01129911 12961374 01069909 03971541 06961191 01039907 06961194 03971430 10961328 05961183 01049819 05971828 10961347 07961212 09961318 04971564 01069804 01079818 09971466 02961097 01039819 01109822 10961337 09961322 12961373 05971830 01971409 01961088 06961187 12971518 04961152 03961122 01089814 05961181 12961377 01029801 02961090 05961164 01060013 01099803 10961348 08971452 05109816 01099805 01971388 01971410 12951076 08971455 09971483 04971798 01039812 06961192 01100001 10961339 03961136 08961286 01129811 07971434 06971411 12971515 08961304 08961303 07961211 01971393 11961350 02961109 03961129 01109811 09961321 01089812 01089817 02961108 10961327 09971461 01059810 01029805 01971397 05971823 03971540 01069803 10961349 09961310 07961220 01049810 01029806 01059807 01059806 09971459 12971512 01099802 11951048 02961115 07971429 02961093 08961306 01019810 06971407 08961297 02961099 01961080 11971506 09961325 01059803 01089816 09961319 06971406 01059812 12952941 08961277 12971517 12961372 01049815 12951070 06961166 06961198 02961096 03961141 06961200 09971468 04971543 11971504 07971433 09961312 06961199 01059802 01971399 03971418 03961121 02961104 08961294 08961302 11961348 06971412 01069807 12961371 01069922 09961311 10961334 10961343 02961089 04961163 10961331 01961087 10961338 12961378 03961127 08961279 01029804 01069811 06961184 01971386 01039810 01039811 01059805 06971409 11961359 05971825 01109814 10961329 01089813 08961300 02961112 01059815 01029803 01079819 01119823 01971385 2100014 02961107 02961116 03961132 03961134 3961140 03961144 04971567 05961171 05961176 05961410 05971829 06961204 07961210 08971454 08971457 09961313 11951046 11961355 12951072 12961380 05971826 08961291 05971820 08961290 05961166 01129830 03971539 01109817 10961341 01971382 07971427 01059804 05971821 03961142 01069935 02961101 08971447 02961117 02961103 06961202 03961139 01039806 08961280 08961283 03971419 01060001 01089801 10971489 12951064 04961149 05961168 01049804 05971824 11971503 11951049 03971537 04971797 04971818 08971453 01971387 06961190 01069812 12951073 11971500 12951069 01029807 12971521 10961345 01019807 09961317 06961185 03971428 02971417 03961146 02961091 08961296 01109802 01059813 05971822 05961173 02961114 09971470 04961148 01971411 11961352 11961367 03971429 01039801 08961295 07961221 06961203 04961161 01109808 08961284 03971427 01049808 08971450 12961381 03961118 10961340 05961167 01069802 09971487 06961195 09971486 10961332 10971490 01089803 12951052 04961160 08961299 03961135 05961178 09961314 02961111 12951077 01019804 05961179 02060204 11961358 03971431 01971413 08961293 02971415 12951071 03971422 07961222 06971403 07961209 01039814 04961150 05961180 01039808 01971394 128A4418 2B8A4B5 31CA4C3 03961131 08961287 07971428 01039823 06961186 12971514 03971420 06971404 08961305 01971383 01019801 01049807 01049916 01059811 01069914 01089907 01129802 06961197 01961082 09971479 04961157 03971421 12975752 09961323 09971481 11961353 04961158 01059808 02961094 04971801 03961123 08961278 06971408 01039809 10961335 04971793 01089809 01039836 02961105 03971432 01019803 11971508 01119828 10971498 04961159 08952566 10971494 02961113 04961153 07971430 01049814 11961360 06971410 03961137 01079903 01029802 08961288 03971426 FSIIIC (International): 03020101 03070004 03-0603-05 03079908 03010016 03-0103-01 02030218 03069931 03119901 03079912 03049805 02080201 03030018 03079902 03080015 03070011
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford, MA, by letter dated July 25, 2011. Firm initiated recall is ongoing.
REASON
The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down.
VOLUME OF PRODUCT IN COMMERCE
540 units
DISTRIBUTION
Nationwide and Argentina, Spain, and Viet Nam
___________________________________
PRODUCT
AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing. Recall # Z-3016-2011
CODE
Serial number logic of TXXXXX or SXXXXX
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 207, Inc., Palm Springs, CA, by letter dated July 15, 2011.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
REASON
the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks being emitted from the device. In the presence of oxygen enriched environments and a fuel source, this failure represents a potential risk of flame. CareFusion is voluntarily recalling the affected devices.
VOLUME OF PRODUCT IN COMMERCE
22,670 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Animas 2020 Insulin Infusion Pump. Recall # Z-3017-2011
CODE
Serial numbers 00-89133-12, 00-89207-12, 14-88703-12, 14-88710-12, 15-88704-12, 15-89190-12, 16-89096-12, 16-89191-12, 17-88720-12, 17-89097-12, 17-89185-12, 17-89611-12, 18-88721-12, 18-89612-12, 19-88715, 18-89099-12, 19-89187-12, 19-89194-12, 19-89620-12, 20-88716-12, 20-89188-12, 20-89621-12, 21-88717-12, 21-88731-12, 21-89196-12, 21-89615-12, 22-88732-12, 22-89616-12, 23-88733-12, 24-88734-12, 25-88728-12, 25-88735-12, 27-88737-12, 28-88738-12, 33-89824-12, 35-89819-12, 36-89827-12, 88-89100-12, 91-89110-12, 92-89111-12, 93-89112-12, 94-89106-12, 94-89120-12, 95-89107-12, 95-89114-12, 95-89121-12, 96-89115-12, 21-88386-12, 21-88393-12, 22-88387-12, 96-89122-12, 96-89210-12, 97-89116-12, 97-89123-12, 97-89130-12, 01-89215-12, 02-89216-12, 02-89223-12, 02-89230-12, 03-89217-12, 03-89224-12, 03-89400-12, 04-89218-12, 04-89225-12, 04-89232-12, 04-89401-12, 05-89219-12, 05-89226-12, 06-89227-12, 06-89234-12, 06-89241-12, 06-89410-12, 07-89235-12, 07-89242-12, 07-89404-12, 07-89411-12, 08-89236-12, 08-89412-12, 09-89237-12, 09-89406-12, 09-89413-12, 10-89238-12, 10-89414-12, 11-89239-12, 11-89408-12, 11-89415-12, 12-89409-12, 13-89417-12, 14-89418-12, 14-89520-12, 15-89521-12, 17-89509-12, 17-89516-12, 18-89517-12, 18-98524-12, 18-89531-12, 19-89525-12, 29-88672-12, 32-88668-12, 32-88682-12, 20-89533-12, 20-89540-12, 21-88643-12, 21-89541-12, 22-89528-12, 22-89535-12, 22-89542-12, 23-88638-12, 23-88740-12, 24-88741-12, 24-89544-12, 25-88647-12, 26-88655-12, 26-89553-12, 27-88751-12, 27-89385-12, 27-89554-12, 27-89561-12, 28-88745-12, 28-89555-12, 29-88760-12, 29-89556-12, 29-89563-12, 30-88747-12, 30-88754-12, 30-88761-12, 30-89395-12, 31-88755-12, 31-88762-12, 31-89558-12, 32-88756-12, 32-89397-12, 33-88757-12, 33-88771-12, 34-88758-12, 34-88772-12, 35-88759-12, 35-88766-12, 36-88774-12, 37-88768-12, 39-88777-12, 39-88939-12, 41-88948-12, 42-88787-12, 51-88979-12, 03-88414-12, 10-89245-12, 33-88690-12, 40-88697-12, 98-89131-12, 14-89256-12, 15-89257-12, 16-89258-12, 17-89273-12, 18-89267-12, 19-89444-12, 20-89269-12, 21-89460-12, 22-88901-12, 22-89461-12, 24-89463-12, 26-88905-12, 27-89466-12, 33-88852-12, 34-88853-12, 35-88854-12, 36-88855-12, 37-88856-12, 39-88872-12, 41-88874-12, 43-88869-12, 47-88887-12, 99-88403-12, 00-88404-12, 00-88411-12, 01-88412-12, 02-88406-12, 02-88413-12, 03-88407-12, 04-88408-12, 04-88415-12, 12-88370-12, 13-88371-12, 14-88372-12, 15-88373-12, 16-88367-12, 16-88381-12, 17-88375-12, 18-88376-12, 18-88383-12, 18-88390-12, 19-88377-12, 19-88384-12, 19-88391-12, 20-88378-12, 20-88385-12, 20-88392-12, 44-88789-12, 00-89140-12, 01-89141-12, 64-83146-12, 00-89221-12, 05-89240-12, 17-89266-12, 22-88394-12, 23-88388-12, 23-88395-12, 24-88389-12, 24-88396-12, 25-88397-12, 26-88398-12, 27-88399-12, 96-88400-12, 99-88410-12, 38-88695-12, 41-88698-12, 09-88603-12, 10-88604-12, 12-88606-12, 12-88613-12, 13-88614-12, 15-88616-12, 22-88637-12, 20-88642-12, 22-88644-12, 23-88645-12, 24-88646-12, 12-89180-12, 08-88602-12, 11-88605-12, 11-88612-12, 19-88627-12, 21-88629-12, 33-88588-12, 51-88993-12, 54-88989-12, 54-88996-12, 86-89003-12, 89-89013-12, 90-89007-12, 92-89016-12, 97-89028-12, 98-89029-12, 19-88641-12, 27-88656-12, 27-88663-12, 27-88670-12, 29-88658-12, 35-88678-12, 35-88685-12, 36-88679-12, 36-88686-12, 36-88950-12, 37-88951-12, 38-88952-12, 39-88953-12, 40-88947-12, 40-88954-12, 41-88955-12, 42-88949-12, 42-88963-12, 27-88920-12, 30-88923-12, 32-88932-12, 33-88933-12, 34-88927-12, 35-88928-12, 35-88935-12, 18-88802-12, 21-88805-12, 23-88807-12, 33-88838-12, 02-89135-12, 03-89136-12, 04-89144-12, 06-89160-12, 08-89148-12, 11-89077-12, 11-89158-12, 12-89159-12, 12-89173-12, 13-89167-12, 18-89179-12, 23-89293-12, 24-89294-12, 25-89295-12, 00-89126-12, 02-89128-12, 03-89129-12, 13-88702-12, 16-88705-12, 17-88706-12, 99-89125-12, 25-88742-12, 26-88743-12, 27-88744-12, 28-88752-12, 29-88739-12, 29-88746-12, 31-88748-12, 32-88749-12, 32-88763-12, 32-88770-12, 34-88765-12, 35-88773-12, 35-88780-12, 38-88769-12, 38-88776-12, 40-88778-12, 15-88380-12, 16-88374-12, 17-88368-12, 17-88382-12, 18-88369-12, 21-88379-12, 32-88851-12, 42-88868-12, 07-89330-12, 11-89334-12, 19-88803-12, 19-88810-12, 21-88812-12, 22-88820-12, 24-88808-12, 25-88809-12, 25-88816-12, 25-88830-12, 26-88831-12, 27-88818-12, 27-88832-12, 29-88827-12, 29-88834-12, 30-88828-12, 31-88829-12, 31-88836-12, 32-88837-12, 01-89303-12, 02-89142-12, 03-89150-12, 04-89151-12, 05-89138-12, 05-89145-12, 06-89139-12, 07-89161-12, 08-89155-12, 09-89149-12, 09-89156-12, 10-89083-12, 10-89090-12, 10-89157-12, 10-89171-12, 11-89165-12, 13-89174-12, 13-89181-12, 14-89094-12, 14-89168-12, 14-89175-12, 15-89176-12, 20-89276-12, 20-89290-12, 21-89277-12, 21-89291-12, 22-89278-12, 22-89292-12, 25-89288-12, 26-89289-12, 26-89296-12, 27-89297-12, 29-89299-12, 30-88930-12, 12-88701-12, 05-89233-12, 26-88750-12, 37-88775-12, 10-89164-12, 36-88693-12, 39-88696-12, 32-88675-12, 33-88676-12, and 30-88835-12
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter dated July, 29 20011. Firm initiated recall is ongoing.
REASON
Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.
VOLUME OF PRODUCT IN COMMERCE
380 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified. Recall # Z-2902-2011
CODE
Serial Numbers: 1518-000003, 1518-000008, 1518-000013, 1518-000014, 1518-000016, 1518-000024, 1518-000029, 1518-000036, 1518-000040, 1518-000044, 1518-000226, 1518-000228, 1518-000231, 1518-000233, 1518-000243, 1518-000349, 1518-000354, 1518-000355, 1518-000389, 1518-000399, 1518-000457, 1518-000752, 1518-000819, 1518-000825, 1518-000846, 1518-000948, 1518-000991, 1518-001341, 1518-001393, 1518-001394, 1518-001395, 1518-001522, 1518-001536, 1518-001654, 1518-001655, 1518-001708, 1518-001734, 1518-001736, 1518-001853, 1518-001972, 1518-002065, 1518-002089, 1518-002097, 1518-002114, 1518-002116, 1518-002117, 1518-002118, 1518-002119, 1518-002120, 1518-002121, 1518-002122, 1518-002123, 1518-002124, 1518-002125, 1518-002126, 1518-002127, 1518-002128, 1518-002129, 1518-002130, 1518-002131, 1518-002132, 1518-002133, 1518-002134, 1518-002135, 1518-002136, 1518-002137, 1518-002138, 1518-002139, 1518-002140, 1518-002141, 1518-002142, 1518-002143, 1518-002144, 1518-002145, 1518-002146, 1518-002147, 1518-002148, 1518-002149, 1518-002150, 1518-002151, 1518-002152, 1518-002153, 1518-002154, 1518-002155, 1518-002156, 1518-002157, 1518-002161, 1518-002162, 1518-002163, 1518-002164, 1518-002166, 1518-002167, 1518-002168, 1518-002169, 1518-002170, 1518-002171, 1518-002172, 1518-002173, 1518-002174, 1518-002175, 1518-002176, 1518-002177, 1518-002178, 1518-002179, 1518-002180, 1518-002181, 1518-002182, 1518-002183, 1518-002184, 1518-002185, 1518-002186, 1518-002187, 1518-002188, 1518-002190, 1518-002191, 1518-002192, 1518-002205, 1518-002206, 1518-002207, 1518-002208, 1518-002209, 1518-002210, 1518-002211, 1518-002212, 1518-002213, 1518-002214, 1518-002215, 1518-002216, 1518-002217, 1518-002218, 1518-002219, 1518-002220, 1518-002221, 1518-002222, 1518-002223, 1518-002224, 1518-002225, 1518-002226, 1518-002227, 1518-002228, 1518-002229, 1518-002230, 1518-002231, 1518-002232, 1518-002233, 1518-002234, 1518-002235, 1518-002236, 1518-002237, 1518-002238, 1518-002239, 1518-002240, 1518-002241, 1518-002242, 1518-002243, 1518-002244, 1518-002245, 1518-002246, 1518-002247, 1518-002248, 1518-002249, 1518-002250, 1518-002251, 1518-002252, 1518-002253, 1518-002254, 1518-002255, 1518-002256, 1518-002257, 1518-002258, 1518-002259, 1518-002260, 1518-002261, 1518-002262, 1518-002263, 1518-002264, 1518-002265, 1518-002266, 1518-002267, 1518-002268, 1518-002276, 1518-002277, 1518-002278, 1518-002279, 1518-002280, 1518-002281, 1518-002282, 1518-002283, 1518-002284, 1518-002285, 1518-002286, 1518-002287, 1518-002288, 1518-002289, 1518-002290, 1518-002291, 1518-002292, 1518-002293, 1518-002294, 1518-002295, 1518-002296, 1518-002297, 1518-002298, 1518-002299, 1518-002300, 1518-002301, 1518-002302, 1518-002303, 1518-002304, 1518-002305, 1518-002306, 1518-002307, 1518-002308, 1518-002309, 1518-002310, 1518-002311, 1518-002312, 1518-002313, 1518-002314, 1518-002315, 1518-002316, 1518-002317, 1518-002318, 1518-002319, 1518-002320, 1518-002321, 1518-002322, 1518-002323, 1518-002325, 1518-002326, 1518-002327, 1518-002328, 1518-002329, 1518-002330, 1518-002331, 1518-002332, 1518-002333, 1518-002334, 1518-002335, 1518-002336, 1518-002337, 1518-002338, 1518-002339, 1518-002340, 1518-002341, 1518-002342, 1518-002343, 1518-002344, 1518-002345, 1518-002346, 1518-002347, 1518-002348, 1518-002349, 1518-002350, 1518-002351, 1518-002352, 1518-002353, 1518-002354, 1518-002355, 1518-002356, 1518-002357, 1518-002358, 1518-002359, 1518-002360, 1518-002361, 1518-002362, 1518-002363, 1518-002364, 1518-002365, 1518-002366, 1518-002367, 1518-002368, 1518-002369, 1518-002370, 1518-002371, 1518-002372, 1518-002373, 1518-002374, 1518-002375, 1518-002376, 1518-002377, 1518-002378, 1518-002379, 1518-002380, 1518-002381, 1518-002382, 1518-002383, 1518-002384, 1518-002385, 1518-002386, 1518-002387, 1518-002388, 1518-002389, 1518-002390, 1518-002391, 1518-002392, 1518-002393, 1518-002394, 1518-002395, 1518-002396, 1518-002397, 1518-002398, 1518-002399, 1518-002400, 1518-002401, 1518-002402, 1518-002403, 1518-002404, 1518-002405, 1518-002406, 1518-002407, 1518-002408, 1518-002409, 1518-002410, 1518-002411, 1518-002412, 1518-002413, 1518-002414, 1518-002415, 1518-002416, 1518-002417, 1518-002418, 1518-002419, 1518-002420, 1518-002421, 1518-002422, 1518-002423, 1518-002424, 1518-002425, 1518-002426, 1518-002427, 1518-002428, 1518-002429, 1518-002430, 1518-002431, 1518-002432, 1518-002433, 1518-002434, 1518-002435, 1518-002436, 1518-002437, 1518-002438, 1518-002439, 1518-002440, 1518-002441, 1518-002442, 1518-002443, 1518-002444, 1518-002445, 1518-002446, 1518-002447, 1518-002448, 1518-002451, 1518-002452, 1518-002453, 1518-002454, 1518-002456, 1518-002457, 1518-002458, 1518-002459, 1518-002460, 1518-002461, 1518-002462, 1518-002463, 1518-002464, 1518-002465, 1518-002466, 1518-002467, 1518-002468, 1518-002469, 1518-002470, 1518-002471, 1518-002472, 1518-002476, 1518-002477, 1518-002478, 1518-002479, 1518-002480, 1518-002481, 1518-002482, 1518-002483, 1518-002484, 1518-002485, 1518-002486, 1518-002487, 1518-002488, 1518-002489, 1518-002490, 1518-002491, 1518-002493, 1518-002494, 1518-002495, 1518-002496, 1518-002497, 1518-002498, 1518-002499, 1518-002500, 1518-002501, 1518-002502, 1518-002507, 1518-002508, 1518-002510, 1518-002511, 1518-002513, 1518-002514, 1518-002517, 1518-002518, 1518-002519, 1518-002520, 1518-002521, 1518-002522, 1518-002523, 1518-002524, 1518-002525, 1518-002526, 1518-002527, 1518-002528, 1518-002529, 1518-002530, 1518-002531, 1518-002532, 1518-002533, 1518-002534, 1518-002535, 1518-002536, 1518-002537, 1518-002538, 1518-002539, 1518-002540, 1518-002541, 1518-002542, 1518-002543, 1518-002545, 1518-002549, 1518-002556, 1518-002557, 1518-002558, 1518-002559, 1518-002560, 1518-002561, 1518-002562, 1518-002563, 1518-002564, 1518-002565, 1518-002566, 1518-002567, 1518-002568, 1518-002569, 1518-002570, 1518-002571, 1518-002572, 1518-002573, 1518-002574, 1518-002575, 1518-002576, 1518-002577, 1518-002578, 1518-002579, 1518-002580, 1518-002581, 1518-002582, 1518-002583, 1518-002584, 1518-002585, 1518-002586, 1518-002587, 1518-002588, 1518-002589, 1518-002590, 1518-002591, 1518-002595, 1518-002606, 1518-002607, 1518-002608, 1518-002609, 1518-002610, 1518-002611, 1518-002612, 1518-002613, 1518-002614, and 1518-005744
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Llc, Issaquah, WA, by letter dated June 20, 2011. Firm initiated recall is ongoing.
REASON
Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
VOLUME OF PRODUCT IN COMMERCE
481 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2959-2011;
2) Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2960-2011;
3) Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. Recall # Z-2961-2011;
4) Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant as cites. Recall # Z-2962-2011
CODE
1) Lot #’s: REUB0097, REUC0050, REUC0344, REUD0610, REUF0562, REUF0720, REUG1336, REUG1398, REUH1217, REUI0188, REUI0189, REUI1235, REUJ0357, REUJ0828, REUJ 0949, REUJ1275, REUK0657, REUK1351, REUL0589, REVA0241, REVA0884, REVB0093, REVB0619, REVC0073, REVC0419;
2) Lot #’s: REUB0097, REUC0050, REUC0344, REUD0610, REUF0562, REUF0720, REUG1336, REUG1398, REUH1217, REUI0188, REUI0189, REUI1235, REUJ0357, REUJ0828, REUJ 0949, REUJ1275, REUK0657, REUK1351, REUL0589, REVA0241, REVA0884, REVB0093, REVB0619, REVC0073, REVC0419;
3) Lot #’s: REUB0099, REUC0051, REUD1012, REUI0191, REUI1181, REUK0310, REVA0246, REVB0890;
4) Lot #’s: REUB0972, REUC0358, REUD0029, REUD0942, REVD0073
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 12, 2011.
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Tamaulipas, Mexico. Firm initiated recall is ongoing.
REASON
Labeling for drainage kit contained incomplete information.
VOLUME OF PRODUCT IN COMMERCE
69,960 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Primal Pet Foods Feline Chicken & Salmon Formula: 4 lb package, frozen, UPC 8 95135-00025-0. Recall # V-374-2011
CODE
Best By date: 043112-17
RECALLING FIRM/MANUFACTURER
Recalling Firm: Primal Pet Foods, San Mateo, CA, by telephone on May 26, 2011 and press release on May 28, 2011.
Manufacturer: Morasch's Meats, Portland, OR. Firm initiated recall is complete.
REASON
Washington State Department of Agriculture collected a sample of Primal Pet Foods Raw Cat Food that resulted in a positive finding for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
72 cases
DISTRIBUTION
CA, WA, AZ, RI, PA, FL, MN, IL, GA, NC, MD
___________________________________
PRODUCT
Bulk boxes labeled as Grandpa Louie's, Dog Treats, consisting of pig ears packaged in cases of 100 pieces or 40 pieces. The product is contained loose in a bulk box and placed in bulk bins for sale at the retail stores. The cases of 100 pieces are the original cases shipped to the recalling firm by the supplier with the Grandpa Louie's label attached. The cases containing 40 pieces are generic cases used by the recalling firm with the Grandpa Louie's label attached. Recall # V-375-2011
CODE
No codes are on the boxes. The recalled product was distributed between 11/19/2010 and 3/18/2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Todd's BBI, Des Moines, IA, by telephone on May 5, 2011 and by letter on May 17, 2011.
Manufacturers: Todd's BBI, Des Moines, IA; Keys Manufacturing Company, Inc., Paris, IL. Firm initiated recall is ongoing.
REASON
The product is potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
16/100-ct. cases and 4/40-ct. cases
DISTRIBUTION
NY, MA, CT, CO, WA, IL, CA, and NV
___________________________________
PRODUCT
Bravo! Bonus Bites Pig Ears Chews (50 count box), Product Code: 75-121. Recall # V-376-2011
CODE
Lot # 12-06-10
RECALLING FIRM/MANUFACTURER
BRAVO! LLC, Vernon, CT, by letter dated May 31, 2011 and by press release on June 3, 2011. Firm initiated recall is ongoing.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
85 boxes (50 count)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pig Ears for Pet Treats, All Natural; 100 count boxes; The boxes have very brief labeling. On two sides of the box are "PET PRODUCTS *** 100 PCS. SMOKED *** 100 PCS. REGULAR" with a box before the 100 to be checked to indicate if they are smoke flavor or plain. On the other two sides of the box is the statement "PET TREATS NOT FOR HUMAN CONSUMPTION". On the bottom of the box are "100 COUNT" and "PIG EARS". Some of the boxes may have a bar code sticker that reads "7 61094 15000 1" "100 Count Natural Pig Ears" One customer had the pig ears individually wrapped and labeled "Petniks Smoked Pig Ears *** Made in USA *** 0 30243 89340 4 *** 98646" then placed in the 100 count box which was labeled "Petniks PORKNIKS SMOKED PORK HIDE CHIPS *** Ingredients: Pork ears *** Product of U.S.A. or Canada Net Wt. 10 LBS *** 8934". Recall # V-377-2011
CODE
Lot number K1010 - date codes SEP 27 2010 through OCT 06 2010; lot number K1011 - date codes NOV 01 2010 through NOV 29 2010; and lot number K1013 - date codes JAN 03 2011 through JAN 25 2011. Please note that these lot numbers do not appear on the 100 count boxes. There is a packaging date on the inside bottom of the box.
RECALLING FIRM/MANUFACTURERi
Keys Manufacturing Co., Inc., Paris, IL, by telephone on April 29, 2011 and letters on April 29, and May 3, 2011 and press release on May 3, 2011. Missouri initiated recall is ongoing.
REASON
The Pig Ears for Pet Treats are being recalled due to possible contamination with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,381 cases
DISTRIBUTION
AR, FL, IL, IN, IA, KS, KY, LA, MI, MN, MO, OH, PA, TX and VA
___________________________________
PRODUCT
Land O Lakes Steakmaker Stress Care 2X B30 AU70, containing 70 g/T chlortetracycline and 30 g/T lasalocid, packaged in 50-lb. bags. Recall # V-378-2011
CODE
Lot # 1JAN28LNC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O Lakes Purina LLC, Shoreview MN, by telephone on April 20&21, 2011.
Manufacturer: Land O'Lakes Purina Feed LLC, Lincoln, NE. Firm initiated recall is complete.
REASON
Elevated urea levels.
VOLUME OF PRODUCT IN COMMERCE
120/50-lb. bags
DISTRIBUTION
NE
___________________________________
PRODUCT
1) Wellness Canned Cat Food Turkey & Salmon Formula, 3.0 oz, 5.5 oz, 12.5 oz. Recall # V379-2011;
2) Wellness Canned Cat Food Beef & Chicken Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-380-2011;
3) Wellness Canned Cat Food Chicken Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-381-2011;
4) Wellness Canned Cat Food Turkey Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-382-2011;
5) Wellness Canned Cat Food Sardine/Shrimp/Crab Formula 3 oz, 5.5 oz,12.5 oz. Recall # V-383-2011;
6) Wellness Canned Cat Food Chicken & Lobster Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-384-2011;
7) Wellness Canned Cat Food Salmon & Trout Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-385-2011;
8) Wellness Canned Cat Food Beef & Salmon Formula 3 oz, 5.5 oz, 12.5 oz. Recall # V-386-2011;
9) Wellness Canned Cat Food CORE Chicken, Turkey & Chicken Liver, 5.5 oz. Recall # V-387-2011;
10) Wellness Canned Cat Food CORE Salmon, Whitefish & Herring, 5.5 oz. Recall # V-388-2011;
11) Wellness Canned Cat Food Kitten Formula 3 oz. Recall # V-389-2011;
12) Wellness Canned Cat Food Chicken & Herring Formula 3 oz, 5.5 oz, 12.5 oz. Recall #V-390-2011
CODE
1) thru 10) Best by dates from 14APR 13 through 30SEP13;
11) Best by dates from 10NOV13 through 30SEP13;
12) Best by dates from 10NOV13 and 17NOV13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wellpet Llc, Tewksbury, MA, by press release on February 28, 2011.
Manufacturers: Simmons Pet Food, Inc., Siloam Springs, AR;
American Nutrition Inc., Ogden, UT. FDA initiated recall is ongoing.
REASON
Cat food subpotent for thiamine (B1).
VOLUME OF PRODUCT IN COMMERCE
21,606,827 cans
DISTRIBUTION
Nationwide, Hong Kong, Singapore
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
Plum A+ Single Channel Infusion Pump for Veterinary Use Only; List number 60529. Recall # V-373-2011
CODE
Serial numbers: 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315025, 14315026, 14315027, 14315028, 14315030, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315318, 14315319, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters on April 21, 2011 and May 26, 2011.
Manufacturer: Hospira Inc., Morgan Hill, CA. FDA initiated recall is ongoing.
REASON
Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.
VOLUME OF PRODUCT IN COMMERCE
450 pumps
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR AUGUST 17, 2011
