Okay, here we go! This, my dear friends, is the mother of all FDA reports. It is published weekly, and you will never believe how long it is--or for that matter what is on it.
Do you think that if you listen to the nightly news you will hear about all of the government issued recalls? You are so wrong.
The list begins mundanely enough with "Class I Foods" and a breakfast cereal. But read on! Everything from neonatal pumps and "reclaimed" blood products to whole blood, surgical instruments and reptile feed pelets are on this list!
The list begins mundanely enough with "Class I Foods" and a breakfast cereal. But read on! Everything from neonatal pumps and "reclaimed" blood products to whole blood, surgical instruments and reptile feed pelets are on this list!
If you or a loved one is having surgery, PLEASE take a scroll through this list. You may even want to print it out and make sure your doctor and his surgical team is aware of what's potentally an unknown danger.
Enforcement Report for July 20, 2011
July 20, 2011 11-29
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Taitan Mixed Cereal, 32GX20, 12 units/carton, UPC 47 10311 92500 3. Recall # F-1534-2011;
2) Taitan Oatmeal with Seafood, 30GX12, 12 units/cartons, UPC 47 10311 98926 5. Recall # F-1535-2011;
3) UCC 3-in-1 Original Blend Mix, 15GX30, 20units/carton, UPC 47 10090 05059 0. Recall # F-1536-2011;
4) UCC Sumiyaki 3-in-1 Coffee Mix, 17Gx10, 24 units/carton, UPC 47 10090 05021 7. Recall # F-1537-2011;
5) UCC Mandheling 3-in-1 Coffee Mix, 17 Gx10, 24 units/carton. UPC 47 10090 05027 9. Recall # F-1538-2011;
6) UCC Special Blend 3-in-1 Coffee Mix, 17GX10, 24 units/carton. UPC 47 10090 05026 2. Recall # F-1539-2011
CODE
Not available.
RECALLING FIRM/MANUFACTURER
Recalling Firm: FJ F C International Inc., Los Angeles, CA, by letter on June 22, 2011 and by press release on June 24, 2011.
Manufacturers: Taiwan Sugar Corp., Tainan City, Taiwan;
Locovo Foods Co., Ltd., Shen Keng Haiang, Taiwan. Firm initiated recall is ongoing.
REASON
The milk protein, Casein Sodium and/or Caseinate were sub-ingredients of an ingredient of the products labeled as "Non-Dairy Creamer."
VOLUME OF PRODUCT IN COMMERCE
1,623 units
DISTRIBUTION
CA, ID, WA, OR, NV, UT, AZ, NY, CT, NJ, MA, TX, AR, MO, WI, IL, MI, MS, FL, TN
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
"P&J Cakes***Bizcocho Vanilla***Mojadito***2.5 lb***Cakes & More Delight's". Recall # F-1513-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Cakes & More Delight's, Inc., Trujillo Alto, PR, by telephone on June 9, 2011. FDA initiated recall is complete.
REASON
Undeclared Yellow #5
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
PR
___________________________________
PRODUCT
Green Planet Vapor Distilled Water + Essential Minerals; bottled in a) 350 mL, UPC 8 94624 00210 2; b) 500 mL (24 bottles per case), UPC 8 94624 00220 1; and c) 1 L (12 bottles per case), UPC 8 94624 00230 0. 100% plant-based plastic bottles. Recall # F-1514-2011
CODE
Produced by" date prior to 05/09/11 or a "CBC best by" date prior to 05/09/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Green Plan et Bottling, LLC, Northbrook, IL, by telephone and letter on June 7, 2011.
Manufacturer: California Bottling Co., Roseville, CA. Firm initiated recall is ongoing.
REASON
The bottled water contains bromate levels in excess of the 0.010 mg L FDA standard of quality limit.
VOLUME OF PRODUCT IN COMMERCE
a) 12,594 cases; b) 103,687 cases; c) 6,496 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Foremost 2% Reduced Fat Milk, 2% Milkfat Vitamin A & D, Half Pint (236mL), Grade A Pasteurized Homogenized. Recall # F-1515-2011
CODE
6/15/11 22-3091 10:38
RECALLING FIRM/MANUFACTURER
Southern Foods Group, LLC d/b/a Foremost Dairy, Shreveport, LA, by visit between June 8 and June10, 2011. Firm initiated recall is complete.
REASON
Diluted food-grade sanitizing water solution was not cleared from a filling line prior to initializing filling operations, resulting in some milk cartons containing the dilution solution.
VOLUME OF PRODUCT IN COMMERC
51,388 1/2 pint units
DISTRIBUTION
TX, LA, MS
___________________________________
PRODUCT
Queso Fresco Fresh Cheese, Net Wt. 5 lb. (80 oz,), UPC 8 58415 0011205, Plant # 36-9845. The recalled fresh Mexican-style cheese is sold in 5-pound foil tray packages. Recall # F-1516-2011
CODE
Lot code: 05/31/11
RECALLING FIRM/MANUFACTURER
Quesos Centroamerica, Corp., Freeport, NY, by visit beginning week of June 13, 2011 and by letter on June 15, 2011. New York initiated recall is complete.
REASON
Product contaminated with Staphylococcus aureus based on sampling and analysis by New York State Department of Agriculture & Markets' Division of Milk Control and Dairy Services.
VOLUME OF PRODUCT IN COMMERCE
Approximately 315 lbs
DISTRIBUTION
NY
___________________________________
PRODUCT
Bacalaitos Criollos***NITA***Codfish Frying Mix***Net wt 9 oz". Recall # F-1519-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Avole, San Sebastian, PR, by visits beginning June 20, 2011. FDA initiated recall is ongoing.
REASON
Undeclared allergen (Yellow# 5)
VOLUME OF PRODUCT IN COMMERCE
3, 456 units
DISTRIBUTION
PR
___________________________________
PRODUCT
Macat brand Dried Apricot Kernels, Net wt: 5 oz (142g) -- UPC 6 908723 382011 -- Product of China -- Nutrition Facts Information: Serving Size: 35.5g, Servings: about 4. Recall # F-1532-2011
CODE
Lot #s: 2992500, 2992600
RECALLING FIRM/MANUFACTURER
Recalling Firm: Strong America Limited, Long Island City, NY, by letters dated July 11, 2011.
Manufacturer: Win Merry Ltd., Kowloon, China.FDA initiated recall is ongoing.
REASON
The dried apricot kernels product contains undeclared sulfites based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
52 cartons (50 x 5 oz. bags per carton)
DISTRIBUTION
NY, MA, NC, VA
___________________________________
PRODUCT
Xphedrine Maximum Strength, Fast Acting Maximum Strength, 12 Tablets, OTC, Dietary Supplement, UPC 6 5899292379 3, Product # 92379. Xphedrine Tablets are contained in a blister card containing 12 tablets per card and are packaged/labeled in a red/white folding carton/box. Recall # F-1533-2011
CODE
Lot # 1101381, Exp 02/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmalife, Inc., Melville, NY, by letter dated June 20, 2011.
Manufacturers: Bactolac Pharmaceutical, Inc., Hauppauge, NY;
Brand Packaging Group, Inc., Farmingdale, NY:
Madcar Company Inc., Ronkonkoma, NY. FDA initiated recall is ongoing.
REASON
Misbranding; dietary supplement labeling makes unapproved claims.
VOLUME OF PRODUCT IN COMMERCE
32,480 units
DISTRIBUTION
AL
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Paroxetine Tablets USP, 20 mg, 90-count bottle, Rx only; NDC# 0093-7115-98. Recall # D-700-2011
CODE
Lot #: 07Y085
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on February 23, 2010.
Manufacturer: Teva Pharmaceutical Industries, Har Hozvim. Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
14,484 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Levoxyl (levothyroxine sodium) Tablets, USP, 75 mcg, 1000-count bottle, Rx only; NDC 60793-852-10; UPC 3 60793 85210 2. Recall # D-704-2011
CODE
Lot #: 60809, Exp 03/31/12
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN, by letter on July 7, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: The firm 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
2,555 bottles (2,555,000 tablets)
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Cyclobenzaprine Hydrochloride 10 mg Tablets USP, 1000-count bottle, Rx only; NDC 50111-563-03; UPC 3 50111-563-03 2. Recall # D-706-2011
CODE
Lot #: 703327, Exp 01/12; 315316, Exp 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2011 and on April 22, 2011.
Manufacturer:Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Some tablets may not conform to weight specifications.
VOLUME OF PRODUCT IN COMMERCE
10,071 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Dexamethasone Sodium Phosphate Injection, USP, 4mg/mL (1 mL SDV) packaged as 25 small bags containing one vial each encased in a larger bag, Rx only, NDC #0517-4901-25. Recall # D-707-2011;
2) Dexamethasone Sodium Phosphate Injection, USP, 4mg/mL (5 mL MDV) packaged as 25 small bags containing one vial each encased in a larger bag, Rx only, NDC #0517-4905-25 5mL MDV. Recall # D-708-2011
CODE
1) Lot Numbers 102307, 092679 and 093761;
2) Lot #092115
RECALLING FIRM/MANUFACTURER
Recalling Firm :American Health Packaging, Columbus, OH, by letter on March 18, 2011.
Manufacturer: Luitpold Pharmaceuticals, Inc., Shirley, NY. Firm initiated recall is ongoing.
REASON
Presence of particulate matter - some vials of the referenced lot codes either contain particulates, or have the potential to form particulates prior to their respective expiration dates.
VOLUME OF PRODUCT IN COMMERCE
1,509 units of 25 vials each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Risperidone Tablets 2 mg, 60 count bottles, Rx only, NDC 50458-593-60. Recall # D-709-2011;
2) Risperdal Tablets (Risperidone), 3 mg, 60 count bottles, Rx only, NDC 50458-330-06. Recall # D-710-2011
CODE
1) Lot # 0LG175, EXP 08-12;
2) Lot # 0GG904, Exp 05-12
RECALLING FIRM/MANUFACTURER
Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by letters on June 16, 2011 and press release on June 17, 2011. Firm initiated recall is ongoing.
REASON
Chemical contamination; TBA
VOLUME OF PRODUCT IN COMMERCE
40, 416 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Lofibra, Fenofibrate Capsules (Micronized), 200 mg, 30 UD, Rx only. NDC 0115-0533-01. Recall # D-701-2011
CODE
Lot #104122, and the Expiration Date: 05/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letter on March 18, 2011.
Manufacturer: Impax Laboratories, Hayward, CA. Firm initiated recall is ongoing.
Manufacturer: Impax Laboratories, Hayward, CA. Firm initiated recall is ongoing.
REASON
Short fill; low-fill weight capsule.
VOLUME OF PRODUCT IN COMMERCE
2,173 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Colace (docusate sodium) Stool Softener Capsules 100 mg, 30 count bottle, OTC, NDC 67618-101-30. Recall # D-702-2011
CODE
Lot #: 0J8151, Exp 06/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purdue Products L.P., Stamford CT, by letters dated April 27, 2011.
Manufacturer: Catalent Pharma Solutions, LLC, Saint Petersburg, FL. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug): Colace (docusate sodium) stool softener 100 mg capsules are being recalled due to an out of specification result for the active ingredient.
VOLUME OF PRODUCT IN COMMERCE
125,112 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, Net wt. 60 g, Rx only, NDC 99207-300-60. Recall # D-703-2011
CODE
Lot #; 143C10A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medicis Pharmaceutical Corp., Scottsdale, AZ, by letters dated May 9, 2011.
Manufacturer: Contract Pharmaceuticals Limited Niagara, Buffalo, NY. Firm initiated recall is ongoing.
REASON
Superpotent: Out-of-specification results for Clindamycin Phosphate, Tretinoin, Methylparaben, and Propylparaben, were obtained during testing of Ziana.
VOLUME OF PRODUCT IN COMMERCE
31,512 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fluor-A-Day Chewable Tablets (Sodium Fluoride, USP & Xylitol), 1.0mg F, 236.79 mg Xylitol NF, 120 tablets per bottle, Rx only, NDC 24338-622-16. Recall # D-705-2011
CODE
Lot number 451910
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arbor Pharmaceuticals Inc., Raleigh, NC, by letter on/about April 20, 2011.
Manufacturer: Pharmascience Inc., Montreal, Canada. Firm initiated recall is ongoing.
REASON
Labeling; Label Error on Declared Strength; label incorrectly states that the tablets are quarter strength and (1.1mg sodium fluoride) but should correctly state the tablets are full strength and 2.2mg (sodium fluoride).
VOLUME OF PRODUCT IN COMMERCE
2,594 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bi Mart Tussin DM, Cough Suppressant/Expectorant, 8 fl oz (237 ml), Relieves Coughs and Chest Congestion; Drug Facts***Active ingredients Dextromethorphan HBr, USP 10 mg***Guaifenesin USP 100 mg. UPC code: 0 71357 00190 3, Product label # G920l-008-ll-2. Same lot from supplier packaged under a different lot numbers. Recall # D-712-2011
CODE
Lot codes: 338495 and 338531, Exp date 08/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Magno Humphries Inc., Tigard, OR, by telephone on February 24, 2009.
Manufacturer: Aaron Industries Inc., Lynwood, CA. Firm initiated recall is ongoing.
REASON
Presence of Precipitate: Tussin DM was observed with fibrous crystalline substance or floating material.
VOLUME OF PRODUCT IN COMMERCE
4397/8 fl. oz bottles
DISTRIBUTION
OR
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Whole Blood CPDA-1. Recall # B-1454-11
CODE
Unit: W115908051288
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno CA, by e-mail on July 31, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Whole Blood CPDA-1. Recall # B-1455-11
CODE
Unit: W115908021558
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on September 5, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1577-11
CODE
Unit: W04231001664800
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings MT, by letter dated May 10, 2011. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1587-11
CODE
Unit: W128708016331
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by fax on December 7, 2009 and follow up letter dated December 30, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1588-11
CODE
Unit: W128709122049
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and fax on September 14, 2009 and follow up letter dated October 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1671-11
CODE
Unit: W090708002012
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by fax on November 7, 2008. Firm initiated recall is complete.
REASON
Blood product, processed from a unit of Whole Blood that had not been tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1672-11
CODE
Unit: K31103
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and fax on June 18, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1673-11
CODE
Unit: F31923
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter dated July 31, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1675-11
CODE
Unit: W0128708102563
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by fax on December 7, 2009 and follow up letter dated January 29, 2010. Firm initiated recall is complete.
REASON
Blood product collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1676-11;
2) Platelets Leukocytes Reduced, Recall # B-1677-11
CODE
1) and 2) Unit: 17KZ79989
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on September 5, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported living in a malarial endemic country for more than 5 years, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, MN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1678-11;
2) Recovered Plasma, Recall # B-1679-11
CODE
1) and 2) W128709140663
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by e-mail on December 3, 2009 and follow up letter dated January 29, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1681-11;
2) Platelets Leukocytes Reduced. Recall # B-1682-11
CODE
1) and 2) Unit: 17KM79253
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on September 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1683-11
CODE
Units: 084FT13722; 084FT13863; 084W95467
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated February 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall #B-1684-11
CODE
Unit: G57596
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated August 22, 2008. Firm initiated recall is complete.
REASON
Blood product collected from a donor taking the drug finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1686-11
CODE
Units: Y07870, Y07873
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on November 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using expired arm scrub reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1703-11
CODE
Unit: W037711500361
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on March 14, 2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1704-11;
2) Platelets. Recall # B-1705-11
CODE
1) and 2) Unit: 53FQ37998
RECALLING FIRM/MANUFACTURER
The American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on March 27, 2011 and by letter on March 30, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Source Plasma. Recall # B-1706-11
CODE
Units: 0100623882, 0100623452, 0100622612, 0100621673, 0100621256, 0100620795, 0100619787, 0100619348, 0100619000, 0100618460, 0100617710
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc., Chattanooga, TN, by fax on April 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose schedule annual physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1707-11
CODE
Units: 0100671512, 0100670920, 0100670204, 0100669540, 0100669010, 0100668172, 0100667936, 0100666884, 0100666293, 0100664942, 0100664698, 0100663801, 0100663585, 0100662747, 0100662394, 0100661739, 0100661249, 0100660635, 0100660373, 0100659624, 0100659257, 0100658486, 0100658234
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc., Chattanooga, TN, by fax on August 28, 2008. 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
23 units
DISTRIBUTION
NC, Switzerland, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1708-11
CODE
Units: 4070202855, 4070202205, 4070201049, 4070200412, 4070199392, 4070198662, 4070197398, 4070181931, 4070174016, 4070173329, 4070172758, 4070171305, 4070170165, 4070169417, 4070168582, 4070167759, 4070165735, 4070164359, 4070163057, 4070162281, 4070161604, 4070159979, 4070159261, 4070158486, 4070157678, 4070155875, 4070155452, 4070154365, 4070152730, 4070151478, 4070150853, 4070149634, 4070148044, 4070147527, 4070146475, 4070144761, 4070144497
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc., Chattanooga, TN, by electronic mail on March 3, 2009. 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
37 units
DISTRIBUTION
IL, Switzerland, Germany
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1710-11;
2) Fresh Frozen Plasma. Recall # B-1711-11
CODE
1) and 2) Unit: G55471
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated March 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1715-11
CODE
Unit: 021LL83937
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone and the LOGIC system on March 12, 2011 and by letters dated March 12, 2011 and March 13, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1717-11
CODE
Unit: KR95835
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile on May 15, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1718-11
CODE
Unit: 1113058
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by telephone on August 29, 2006. Firm initiated recall is complete.
REASON
Blood product, for which the Cytomegalovirus (CMV) testing was not correctly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Hawaii
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1721-11;
2) Recovered Plasma. Recall # B-1722-11
CODE
1) and 2) Unit: W090708004213
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile on September 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1723-11
CODE
Unit: 8518064
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on April 26, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1724-11
CODE
Unit: 1657940
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated July 22, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Hawaii
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1725-11
CODE
Unit: 1660416
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter on September 8, 2008. 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
HI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1730-11
CODE
Unit: W128708140646
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile dated December 7, 2009 and by letter dated January 29, 2010. 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, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1732-11
CODE
Unit: W128708403792
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on January 29, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1735-11
CODE
Unit: 11MTNA5065
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1736-11
CODE
Unit: 22LC81025
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter on April 22, 2011 and April 25, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, PA
___________________________________
PRODUCT
Red Blood Cells Leu8kocytes Reduced. Recall # B-1738-11
CODE
Units: 22FR31863; 22FR32077; 22GZ52069; 22LC82010; 22LC82019
RECALLING FIRM/MANUFACTURER
Amrican National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and letter on April 22, 2011. Firm initiated recall is complete.
REASON
Blood products, positive for the E-antigen but labeled as E-antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1739-11
CODE
Units: 22FS46558 Part 1; 22FS46558 Part 2
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on April 12, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1762-11;
2) Recovered Plasma. Recall # B-1763-11;
3) Cryoprecipitated AHF, Pooled. Recall # B-1764-11
CODE
1), 2) and 3) Unit: W044111101193
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Sioux City, IA, by e-mail on April 4, 2011 and letter dated April 19, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, IA, Austria
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1674-11
CODE
Unit: W0128708102563
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by fax on December 7, 2009 and follow up letter dated January 29, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Recovered Plasma. B-1680-11
CODE
Unit: 17KM79253
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on September 21, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1685-11
CODE
Unit: G57596
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated August 22, 2008. Firm initiated recall is complete.
REASON
Blood product collected from a donor taking the drug finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1716-11
CODE
Unit: 021LL83937
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone and the LOGIC system on March 12, 2011 and by letters dated March 12, 2011 and March 13, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1731-11
CODE
Unit: W128708140646
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile dated December 7, 2009 and by letter dated January 29, 2010. 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, Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1737-11
CODE
Unit: 22LC81025
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter on April 22, 2011 and April 25, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, PA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1740-11
CODE
Unit: 35KC80104
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by letter and electronic mail dated May 5, 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
Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Brand names: 1) Allegiance, Cat. LJT2. Net Wt. 2 oz, Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; 2) Select medical products, Reorder #137, 3 g/packet, Reorder #136, 4 oz; 3) Novaplus, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz, Cat. No. V10-8917, Net Wt. 2 oz; 4) Triad Group, Inc., Cat. No. 10-8917, Net Wt. 2 oz, Cat. No. 10-8946, Net Wt. 5 g, Triad Plus Cat. No. 11-8344, 3 g, Cat. No. 11-8472, 5 grams, Cat. No. 10-8919, Net Wt. 4 oz, Cat. No. 10-8500, Net Wt. 4 oz; 5) IMCO, Reorder No. 8919-IMC Net Wt. 4 oz; 6) McKesson Medi-Pak Performance, Reorder No. 66-8919, Net Wt. 4 oz; 7) Henry Schein, Net Wt. 4 fl. oz. Recall # Z-0934-2011
CODE
All Lot numbers beginning with the digits 7, 8, 9, or 0
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc. dba Triad Group, Hartland, WI, letter dated December 22, 2010. FDA initiated recall is ongoing.
REASON
Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products.
VOLUME OF PRODUCT IN COMMERCE
453,757 cases
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures. Recall # Z-2383-2011
CODE
Lot Number: 252410KC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus Acmi, Inc., Southborough, MA, by letter dated April 15, 2011.
Manufacturer: Gyrus Medical, Inc., Osseo, MN. Firm initiated recall is ongoing.
REASON
As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed. Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accessory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides). Recall # Z-2411-2011
CODE
Serial Numbers: 20100043034 to 20100043045
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linet Americas Inc., Charlotte, NC, by telephone on May 5, 2011 and letter dated May 11, 2011.
Manufacturer:Linet Spol Sr.O, Slany, Czech Republic. Firm initiated recall is ongoing.
Manufacturer:Linet Spol Sr.O, Slany, Czech Republic. Firm initiated recall is ongoing.
REASON
Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.
VOLUME OF PRODUCT IN COMMERCE
1,601 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2579-2011
CODE
XiO Release 4.30. and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by notice dated September 14, 2010. Firm initiated recall is ongoing.
REASON
XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port shape.
VOLUME OF PRODUCT IN COMMERCE
1,208 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 Units***STERILE OE***Latex-Free. To control intravascular infusion of medication. Recall # Z-2601-2011
CODE
Lot numbers: 101444L and 101494L
RECALLING FIRM/MANUFACTURER
Leventon S. A. U., Barcelona, Spain, by letter dated March 11, 2011. Firm initiated recall is ongoing.
REASON
Product has potential to leak.
VOLUME OF PRODUCT IN COMMERCE
1,000 cases (50,000 units)
DISTRIBUTION
FL
___________________________________
PRODUCT
BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing. Recall # Z-2608-2011
CODE
Lot number: 1034119 Exp. 2011/05/03
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., D Diagnostic Systems, Sparks, MD, by letter dated April 2011.
Manufacturer: Becton-Dickinson Diagnostics, Inc., Madison, WI. Firm initiated recall is ongoing.
REASON
Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.
VOLUME OF PRODUCT IN COMMERCE
5,440 plates
DISTRIBUTION
Nationwide, Canada, Columbia, Jamaica, South Korea, and Taiwan
___________________________________
PRODUCT
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "Pro Trainers' Choice' Company, Inc.***. The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***". Recall # Z-2659-2011
CODE
Serial numbers range from 100116 to 100452.
RECALLING FIRM/MANUFACTURER
Pro Trainers' Choice Co., Kingston, WA, by letters on April 18, 2011 and April 20, 2011. Firm initiated recall is ongoing.
REASON
The control panel of the Precision Ice One Patient Use Control Unit and Wrap System has a overheating issue. The control panel printed circuit boards were missing a jumper connection across resistors R28 A, B, C, and D.
VOLUME OF PRODUCT IN COMMERCE
336 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2664-2011;
2) HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2665-2011;
3) LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2666-2011;
4) LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. Recall # Z-2667-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter, dated May 24, 2011. Firm initiated recall is ongoing.
REASON
20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
VOLUME OF PRODUCT IN COMMERCE
1,531 units
DISTRIBUTION
Nationwide, Belgium, Japan, and Singapore
___________________________________
PRODUCT
1) RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Catalog number: 121610 and 858510. Recall # Z-2695-2011;
2) RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Catalog number: 121502. Recall # Z-2696-2011;
3) RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway. Catalog number: 121556. Recall # Z-2697-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by notice dated January 4, 2011
Manufacturer: Teleflex Medical Sdn Bhd, Kamunting Perak, Malaysia. Firm initiated recall is ongoing.
REASON
Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
VOLUME OF PRODUCT IN COMMERCE
328,727 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test. Recall # Z-2740-2011
CODE
Lot numbers: 10042001, 9081001, 9112403, 9030902 and 9030901
RECALLING FIRM/MANUFACTURER
Recalling Firm : bioMerieux, Inc., Durham, NC, by letter on/about May 10, 2011.
Manufacturer: Biomerieux Vitek Inc., Lyon, France. Firm initiated recall is ongoing.
REASON
The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.
VOLUME OF PRODUCT IN COMMERCE
42 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck; Part number 5290-744-100. Recall # Z-2794-2011
CODE
Lot number: 10265CG2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter on June 13, 2011.
Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.
REASON
Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.
VOLUME OF PRODUCT IN COMMERCE
95 units
DISTRIBUTION
Nationwide and Australia, Duisburg, Newbury and Hong Kong
___________________________________
PRODUCT
XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex during perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018. Recall # Z-2795-2011
CODE
Addex THAM 50, lot number 2570350. Relabeled and distributed as THAM, REF 99019, lots 502518, 502590, 502663, 502664, 502688, 502709, 502735, 502774, 502809, 502822, 502834. Perfadex with THAM kit, 8 x 1000mL REF 19017, 502522 (502518) 502591 (502590) 502662 (502664) 502689 (502688) 502734 (502735) 502807 (502809) 502835 (502834). (Number in parenthesis is THAM LOT number used in kit) Perfadex with THAM kit 2 x 2800mL REF 19018: 502521 (502518) 502663 (502664) 502708 (502709) 502743 (502774) 502808 (502809) 502823 (502822) 502826 (502822). (Number in parenthesis is THAM LOT number used in kit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vitrolife, Inc., Englewood, CO, by letter on May 13, 2011.
Manufacturer: Vitrolife Sweden Ab, Goteborg, Sweden. Firm initiated recall is ongoing.
REASON
Precipitation observed in some bottles of electrolyte used for perfusion of donor lungs.
VOLUME OF PRODUCT IN COMMERCE
1,442 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Product Codes: a) 2 M8153 and b) 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Recall # Z-2796-2011
CODE
a) Serial numbers: 9070872CT and 12120279CT; b) Serial numbers: 14082199TC, 14090543TC, 13120195TC, 13120172TC, 13100660TC, 15041195TC, 11120467TC, 14082067TC, 12010398TC and 12010355TC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone beginning May 4, 2011.
Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Firm initiated recall is ongoing.
REASON
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
VOLUME OF PRODUCT IN COMMERCE
12 pumps
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. Recall # Z-2837-2011
CODE
Lot number: UR09H05029, expiration date 8/25/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated July 6, 2011.
Manufacturer: Baxter Healthcare of Puerto Rico S.A., Aibonito, PR, Firm initiated recall is ongoing.
REASON
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
9,800 sets
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Frozen Reptile Feed (mice, rats and chicks), packed in clear plastic bags. Recall # V-370-2011
CODE
M-SP100, M-P100, M-PF100, M-F100, M-H100, M-W50, M-A50, M-JA25, R-P100, R-F50, R-PUP50, R-W50, R-S50, R-M20, R-L10,R-J5, R-C5, R-M3 followed by E9, F9, G9, H9, I9, J9, K9, L9 or A10, B10, C10, D10, E10, F10, G10 and whole frozen chicks in 25 count.
RECALLING FIRM/MANUFACTURER
Biggers & Callaham, Inc., Cleveland, GA, by press release on July 27, 2010, by e-mail on July 30, 2010 and by e-mail and letter on February 7, 2011. FDA initiated recall is ongoing.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,000 bags/100 units per bag
DISTRIBUTION
Nationwide, PR, Canada, Great Britain, Scotland and Thailand
END OF ENFORCEMENT REPORT FOR JULY 20, 2011
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