Stinky News...

Good-morning. 

It’s a very busy time at the FDA this week.  Yesterday, FDA  issued its Field Enforcement Report for recalled foods, drugs and medical devices—29 pages worth!  It was so long and tedious to read through that I have divided it up into four separate posts.  (You can find the links in the side bar on the right of this page.)  This way, if you’re interested in recalled foods you can go straight to that.  If you’re interested in products your pet might use, it will be under Veterinary, and so on.

An interesting situation that keeps recurring lately is that psychotropic drugs are being implicated in more and more serious and diverse reactions, interactions and the initiation of new disease processes.  I cannot emphasize strongly enough that before you or a loved-one embarks upon taking any of these drugs, you should do diligent research into what their side-effects are!  All these new drugs are nothing more than a money-making mass experiment on the general population which results in 100’s of thousands of deaths each year.  See: clipped from Google - 7/2011

Deadly risk found mixing Pfizer's Zyvox with certain drugs   Jul 28, 2011- 8 hours ago

Another trend I’ve noticed is that Tylenol® and Rolaids® products are forever in the news because of some mysterious stench associated with the medication.

The industry keeps citing that their products were stacked on stinky pallets, and similar explanations.  …excuse  me?  Something about that doesn’t wash with me.  I’ve been around a lot of dirty pallets—some so decrepit that they were being tossed out, and I simply cannot imagine a *usable* pallet that would smell so offensively as to permeate the palletizing wrap, the PVC plastic and foil medication safety packaging and saturate its contents to such alarming levels!  Hamlet was right…”Something is rotten…” Anyway, “forewarned is fore armed,” as they say.  So “heads up” and keep an eye open for more on this!

Related links:

Don't Blame Us: Pallet industry tells tainted Tylenol maker - Jan ...

Tylenol Problems Affected Extra Strength And Rolaids - ABC News

VETERINARY - CLASS I (FDA Recalls and Field Corrections)

Fallout from recent pet food recall.: An article from: Nutraceuticals World

PRODUCT

Bongards' creameries Perham Whey Proteins, Pc-Protein, Net Weight:  19.95806 KG / 44 lbs. Product Guarantee: Crude Protein.....55.0% Min. Crude Fat.....10% Min. Crude Fiber.....0.0% Max., Carbohydrate.....35.0% Max. whey Protein Concentrate (a milk derivative). Recall # V-371-2011

CODE

Lot numbers: 110110, 110210, 110510, 111110, 111210, 111510, 111710, 111810, 112110, 112210, 112610, 112710, 120110, 120210, 120710, 120810, 121510, 122310, 122410, 010311, 010411, 010911, 011011, 011511, 011611

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bongards' Creameries, Norwood Young America, MN, by letterdated May 1, 2011.

Manufacturer: Bongards' Creameries, Perham, MN. Firm initiated recall is ongoing.

REASON

Bongards' Creameries is recalling a limited quantity of Pc-Protein powder because it has the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

567,468 lbs

DISTRIBUTION

MN, MT

The homemade diet: in light of the major pet food recall, is it safest to make your cat's meals yourself? Experts discuss the pros and cons.(Noteworthy): An article from: Cat Watch

DEVICES - CLASS II (FDA Recalls and Field Corrections)

PRODUCT

Condyle Kit with Hexalobular, REF 114700 Discovery Elbow System, Humeral Condyle Set - Hexalobular, CO-CR-MO YI-GAL-4V Alloy, If Used For Revision Surgery, Instruments 414926 & 414923 May be Required Lot 183300, 1 Set, Expiry Date: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications. Recall # Z-2660-2011

CODE

Lot # 183300

RECALLING FIRM/MANUFACTURER

Biomet, Inc., Warsaw, IN, by letter dated May 25, 2011. Firm initiated recall is ongoing.

REASON

The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.

VOLUME OF PRODUCT IN COMMERCE

10 kits

DISTRIBUTION

Nationwide and Japan

___________________________________

PRODUCT

Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings. Recall # Z-2662-2011

CODE

MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs

RECALLING FIRM/MANUFACTURER

Impac Medical Systems Inc., Sunnyvale, CA, by letter on March10, 2011. Firm initiated recall is ongoing.

REASON

There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.

VOLUME OF PRODUCT IN COMMERCE

840 units

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

Sequoia final driver closure top retention, non-sterile, REF 3384-2. The device is used to apply final torque to closure tops of the implant. The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal. Recall # Z-2705-2011

CODE

Units: 60LJ, 60LK, 60LL, 61HZ, 61RS, 64DC, 64DC

RECALLING FIRM/MANUFACTURER

Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated April 4, 2011.

Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.

REASON

A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.

VOLUME OF PRODUCT IN COMMERCE

505 units

DISTRIBUTION

Nationwide, Czech Republic, Denmark, France, Singapore, Spain, Switzerland, and United Kingdom

___________________________________

PRODUCT

SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports). Recall # Z-2714-2011

CODE

Versions 1.1.6.x and 1.1.7.x.

RECALLING FIRM/MANUFACTURER

SCC Soft Computer, Clearwater, FL, by letter dated June 9, 2010. Firm initiated recall is ongoing.

REASON

Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.

VOLUME OF PRODUCT IN COMMERCE

49 units

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System, part number 07-008, catalog number REF 8002. Recall # Z-2742-2011

CODE

Lot numbers HMO196 and HMO197, expiration date July 2011

RECALLING FIRM/MANUFACTURER

Haemoscope Division of Haemonetics Corp., Niles, IL, by letter dated March 2, 2011. Firm initiated recall is ongoing.

REASON

Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).

VOLUME OF PRODUCT IN COMMERCE

568 kits

DISTRIBUTION

Nationwide, Canada, Czech Republic and the Philippines

___________________________________

PRODUCT

Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, Sterile. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter. Recall # Z-2746-2011

CODE

Lot #s: 10306012, 10323012, 10340022, 11007012 and 11047012

RECALLING FIRM/MANUFACTURER

Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated May 27, 2011. Firm initiated recall is ongoing.

REASON

The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.

VOLUME OF PRODUCT IN COMMERCE

87 Boxes/435 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560. Recall # Z-2747-2011

CODE

All lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by letter dated May 19, 2011.

Manufacturer: Covidien LP, Mansfield, MA. Firm initiated recall is ongoing.

REASON

A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis.

VOLUME OF PRODUCT IN COMMERCE

13,942 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. It has a System Part Number: 989605392501, 989605396032, 989605395201. Tool Connection Unit Part Number: 453561426002, 453561443201 The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another. Recall # Z-2769-2011

CODE

System Code Serial Numbers are: 03B8QR, B00DQ2, B00HZR, B00J3F, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, and B00PPP. The Tool Connection Units with the following serial numbers are: B00J0G, B00J0H, B00J0M, B00J0N, B00J0Q, B00J0R, B00J0X, B00J0Y, B00J10, and B00J20

RECALLING FIRM/MANUFACTURER

Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, byletter dated May 27, 2011.

Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.

REASON

PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.

VOLUME OF PRODUCT IN COMMERCE

10 units

DISTRIBUTION

Nationwide, Australia, India, Netherlands, and South Korea  

_________________________________

PRODUCT

Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands, H14, H19, H27, H29, Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-2778-2011

CODE

Serial Numbers: H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068

RECALLING FIRM/MANUFACTURER

Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 13, 2011. Firm initiated recall is ongoing.

REASON

Some drive stand bolts may fail to meet mechanical specifications.

VOLUME OF PRODUCT IN COMMERCE

36 units

DISTRIBUTION

Nationwide, Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom

___________________________________

PRODUCT

Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-2782-2011

CODE

Serial numbers: DYUJA023, DYUJA024, DYUJA025, DYUJA026, DYUJA027, DYUJA028, DYUJA029, DYUJA030, DYUJA031, DYUJA032, DYUJA034, DYUJA036, DYUJA037, DYUJA038, DYUJA039, DYUJA040, DYUKA001, DYUKA002, DYUKA003, DYUKA004, DYUKA005, DYUKA006, DYUKA007, DYUKA008, DYUKA009, DYUKA010, DYUKA011, DYUKA012, DYUKA013, DYUKA014, DYUKA015, DYUKA015, DYUKA017, DYUKA018, DYUKA019, DYUKA020, DYVAA001, DYVAA002, DYVAA003, DYVAA004, DYVAA005, DYVAA006, DYVAA007, DYVAA012, DYVAA013, DYVAA014, DYVAA015, DYVAA016, DYVAA017, DYVAA018, DYVAA019, DYVAA020, DYVAA021, DYVAA022, DYVAA023, DYVAA024, DYVAA025, DYVAA026, DYVAA027, DYVAA028, DYVAA029, DYVAA030, DYVAA031, DYVAA032, DYVAA033, DYVAA036, DYVAA037, DYVAA038, DYVAA039, DYVAA040, DYVBA002, DYVBA003, DYVBA004, DYVBA005, DYVBA006, DYVBA007, DYVBA008, DYVBA009, DYVBA010, DYVBA011, DYVBA012, DYVBA013, DYVBA014, DYVBA015, DYVBA018, DYVBA019, DYVBA020

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated June 2011.

Manufacturer: Dymax Corp., Warrendale, PA. Firm initiated recall is ongoing.

REASON

Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.

VOLUME OF PRODUCT IN COMMERCE

86 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection. a) Catalog number: A1300VA, b) Catalog number: A1300. Recall # Z-2831-2011

CODE

a) Lot number: 02E1002552; b) Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302

RECALLING FIRM/MANUFACTURER

Teleflex Medical, Durham, NC, by letter dated June 27, 2011. Firm initiated recall is ongoing.

REASON

The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.

VOLUME OF PRODUCT IN COMMERCE

6,880 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: "Marus Dental". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures. Recall # Z-2834-2011

CODE

None

RECALLING FIRM/MANUFACTURER

Dental Equipment LLC, Newberg, OR, by letter on June 24, 2011. Firm initiated recall is ongoing.

REASON

Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.

VOLUME OF PRODUCT IN COMMERCE

13,258 units

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT

OneTouch Delica Lancing Device; Testing of Blood Glucose Levels. Model Number 022-137-01. Recall # Z-2835-2011

CODE

None

RECALLING FIRM/MANUFACTURER

Recalling Firm: Lifescan Inc., Milpitas, CA, by letter dated May 27, 2011.

Manufacturer: Facet Technologies LLC, Kennesaw, GA. Firm initiated recall is ongoing.

REASON

Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.

VOLUME OF PRODUCT IN COMMERCE

1,032,515

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit. Product code: CLXUSA. Recall # Z-2839-2011

CODE

Lot: Y302

RECALLING FIRM/MANUFACTURER

Therakos Inc., Raritan, NJ, by letter dated December 2, 2010. Firm initiated recall is ongoing.

REASON

Cellex Procedural kits may have minor tears in their Tyvek covers.

VOLUME OF PRODUCT IN COMMERCE

110 units

DISTRIBUTION

Nationwide

BIOLOGICS - CLASS II (FDA Recalls and Field Corrections)

PRODUCT

Recovered Plasma. Recall # B-1381-11

CODE

Units: R23959, J06578

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on July 24, 2009. Firm initiated recall is complete.

REASON

Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

Austria

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1545-11

CODE

Unit: # G19011

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on October 27, 2008 and by letter dated February 27, 2009. 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

CA

___________________________________

PRODUCT

1) Fresh Frozen Plasma. Recall # B-1612-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1613-11

CODE

1) and 2) Unit: W128708013998

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and facsimile on December 31, 2008 or January 2, 2009. Firm initiated recall is complete.

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA

___________________________________

PRODUCT

1) Red Blood Cells. Recall # B-1616-11;

2) Fresh Frozen Plasma. Recall # B-1617-11;

3) Red Blood Cells Leukocytes Reduced. Recall # B-1618-11;

4) Recovered Plasma. Recall # B-1619-11

CODE

1) Unit: 1269827;

2) Unit: 8225976;

3) Units: 8208190; 8506204; 8225976; 8247892; 8008477; 8700662;

4) Units: 1269827; 8208190; 8506204; 8247892; 8008477; 8700662

RECALLING FIRM/MANUFACTURER

Houchin Blood Services, Bakersfield, CA, by facsimile on December 16, 2005. Firm initiated recall is complete.

REASON

Blood products, collected from previously deferred donors, were distributed.

VOLUME OF PRODUCT IN COMMERCE

14 units

DISTRIBUTION

CA, NJ and Switzerland

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1621-11

CODE

Unit: W128708016088

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on December 1, 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 and Austria

___________________________________

PRODUCT

Platelets Pooled Leukocytes Reduced. Recall # B-1629-11

CODE

Unit: W0352110312665

RECALLING FIRM/MANUFACTURER

Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated May 25, 2011. Firm initiated recall is complete.

REASON

Blood product, which was not tested for pH, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1693-11

CODE

Unit: W038510385512

RECALLING FIRM/MANUFACTURER

Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 7 and February 19, 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

TN

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1697-11

CODE

Units: 017FR94348; 017LG20632

RECALLING FIRM/MANUFACTURER

The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 19, 2011. Firm initiated recall is complete.

REASON

Blood products, phenotyped positive for the Jk(a)antigen but labeled as Jk(a) antigen negative, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

MN

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1729-11

CODE

Units: W128710061831(part 1); W128710061831(part 2)

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated April 2, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

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-1738-11

CODE

Units: 22FR31863; 22FR32077; 22GZ52069; 22LC82010; 22LC82019

RECALLING FIRM/MANUFACTURER

American 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

Red Blood Cells Leukocytes Reduced. Recall # B-1746-11

CODE

Units: 017GV92560, 017GV92738

RECALLING FIRM/MANUFACTURER

The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 23, 2011 and by letters dated April 1, 2011 and April 25, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

MN

___________________________________

PRODUCT

Source Plasma. Recall # B-1748-11

CODE

Units: I75119280; I75118994; I75118564; I75118312; I75117828; I75117163; I75116852; I75116422; I75116167; 391005022; 391003441; 391002655; 391002120; 391001831; 391001295; 391001051; 391000502; I75120250; I75110668; I75110249; I75109946; I75108482; I75108176; I75107695; I75107407; I75106729; I75106172; I75103172; I75103608; I75103905; I75104802; I75105119; I75109076; I75109393; I75105845; I75100317; I75100614; I75100950; I75101451; I75101732; I75102150; I75102431; I75102850; I75092752; I75093016; I75098206; I75098471; I75098881; I75099316; I75089934; I75090674; I75091017; I75091262; I75091600; I75091825; I75092150; I75092391; I75087714; I75088249; I75088474; I75088767; I75088987; I75089329; I75089589; I75085850; I75086073; I75086333; I75086502; I75086909; I75081458; I75082015; I75082569; I75082969; I75085319; I75085574; I75075395; I75076447; I75077055; I75078586; I75079108; I75079691; I75080274; I75080850; I75067608; I75068176; I75071039; I75071733; I75072210; I75072733; I75073725; I75074266; I75061344; I75063924; I75064520; I75065090; I75065572; I75066064; I75066583; I75067068; I75057187; I75057693; I75058235; I75058716; I75059215; I75059719; I75060247; I75060768; I75052150; I75052720; I75053249; I75053738; I75054095; I75054620; I75055621; I75056635; I75049283; I75044242; I75045309; I75047471; I75047978; I75048487; I75049982; I75050522; I75048701; I75043121; I75042528; I75041954; I75041394; I75040837; I75036345; I75036308; I75086731; I75087403; I75087192; I75087928

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., North Las Vegas, NV, by telephone and facsimile on June 9, 2007. Firm initiated recall is complete.

REASON

Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

135 units

DISTRIBUTION

CA, KY, NC, NV and Austria

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1749-11

CODE

Unit: W045011024680

RECALLING FIRM/MANUFACTURER

Community Blood Center of Greater Kansas City, Kansas City, MO, by fax on June 11, 2011. 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

MO

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1750-11

CODE

Units: 7206271; 7206271

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 12, 2011. 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

2 units

DISTRIBUTION

TX

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1751-11

CODE

Unit: W142810357308

RECALLING FIRM/MANUFACTURER

Tri-counties Blood Bank, San Luis Obispo, CA, by letter dated June 13, 2011. 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-1754-11

CODE

Unit: 70200728640

RECALLING FIRM/MANUFACTURER

Csl Plasma, Inc., Aurora, CO, electronically on May 4, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who received an accidental needlestick within 3 months of donating, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Switzerland

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1766-11;

2) Cryoprecipitated AHF. Recall # B-1767-11

CODE

1) and 2) W035210002179Q

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

Austria, TX, NC

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1774-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1775-11;

3) Cryoprecipitated AHF. Recall # B-1776-11

CODE

1) Unit: W053310603542;

2) Units: W053309607211; W053309605013; W053309603116; W053308605365; W053310608876; W053310606359;

3) Unit: W053310606359

RECALLING FIRM/MANUFACTURER

Community Blood Center, Inc., Appleton WI, by telephone and follow-up letter on May 4, 2011. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

8 units

DISTRIBUTION

Switzerland, MA, NY, MO, MS, WI

___________________________________

PRODUCT

1) Recovered Plasma. Recall # B-1777-11;

2) Cryoprecipitated AHF. Recall # B-1778-11;

3) Cryoprecipitated AHF, Pooled. Recall # B-1779-11

CODE

1) Unit: W036510044604;

2) Units: W036510044604; W036510153556;

3) Unit: W036510153556

RECALLING FIRM/MANUFACTURER

LifeShare Blood Centers, Shreveport LA, by facsimile on May 20, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

Switzerland and LA

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1780-11;

2) Cryoprecipitated AHF, Pooled. Recall # B-1782-11

CODE

1) Unit: 16KJ72174;

2) Unit: 16N43286

RECALLING FIRM/MANUFACTURER

American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

OH, NJ, CA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced Irradiated Washed. Recall # B-1783-11

CODE

Unit: W066510602196

RECALLING FIRM/MANUFACTURER

Blood Bank of Alaska, Inc., Anchorage, AK, by telephone on May 24, 2011 and facsimile on June 7, 2011. Firm initiated recall is complete.

REASON

Blood product, mislabeled as to antigen phenotype, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AK

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1784-11

CODE

Unit: W041011033640* (2 units)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems, Inc., Albuquerque, New Mexico, by telephone on March 29, 2011.

Manufacturer: Blood Systems, Inc dba United Blood Services, Scottsdale, AZ. Firm initiated recall is complete.

REASON

Blood products, which were incorrectly labeled as negative for the Kell antigen, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

New Mexico

____________________________________

PRODUCT

Source Plasma Recall # B-1786-11

CODE

Unit: 5030111748

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., Atlantic Beach, FL, by facsimile on May 11, 2011. Firm initiated recall is complete.

REASON

Blood product, for which the sample for viral marker testing may have been diluted, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT

Platelets. Recall # B-1787-11

CODE

Unit: W087211004273

RECALLING FIRM/MANUFACTURER

Central Blood Bank, Pittsburgh, PA, by telephone and facsimile on April 25, 2011. Firm initiated recall is complete.

REASON

Blood product, associated with a red cell unit that may have been contaminated, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

PA

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1788-11

CODE

Unit: F24440

RECALLING FIRM/MANUFACTURER

Michigan Blood, Grand Rapids, MI, by electronic notification on May 20, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Switzerland

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1789-11

CODE

Unit # 53GG50054

RECALLING FIRM/MANUFACTURER

American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 5, 2011. Firm initiated recall is complete.

REASON

Blood product, for which the quality control testing was not performed, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MD

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1790-11

CODE

Unit: W158011600314

RECALLING FIRM/MANUFACTURER

Arup Laboratories, Inc., Sandy, UT, by e-mail on May 20, 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

UT

___________________________________

PRODUCT

1) Cryoprecipitated AHF, Pooled. Recall # B-1791-11;

2) Recovered Plasma. Recall # B-1792-11;

3) Red Blood Cells.  Recall # B-1793-11;

4) Fresh Frozen Plasma. Recall # B-1794-11

CODE

1) Unit: W035410057932;

2) Unit: W035410068461;

3) Units: W035410068461, W035410033438;

4) Unit: W035410033438

RECALLING FIRM/MANUFACTURER

Community Blood Center, Dayton, OH, by telephone on May 12, 2011 and by facsimile on May 13 and 17, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION

Austria, OH

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1797-11

CODE

Unit: 7203222

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on May 12, 2011. Firm initiated recall is complete.

REASON

Blood product, which did not meet acceptable product specifications, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT

1) Fresh Frozen Plasma. Recall # B-1799-11;

2) Platelets. Recall # B-1800-11;

3) Red Blood Cells Leukocytes Reduced. Recall # B-1802-11

CODE

1) Units: W0352092626557; 9569604; W035209132071U;

2) Units: 9569604; W035209132071U;

3) Units: 9569604; W035209132071U; W0352092626557

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 24, 2011. 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

8 units

DISTRIBUTION

TN, TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________

PRODUCT

Recovered Plasma. Recall # B-1620-11

CODE

Unit: W128708016088

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on December 1, 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 and Austria

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1709-11

CODE

Units: W128709060865, W128709010584

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated March 6, 2009. Firm initiated recall is complete.

REASON

Blood product, was labeled with incorrect anticoagulant and product volumes, was distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1712-11;

2) Red Blood Cells. Recall # B-1713-11

CODE

1) Unit: P78322;

2) Units: T30644, P44737

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile dated March 16, 2009 and letter dated June 26, 2009. Firm initiated recall is complete.

REASON

Blood products, collected from a donor taking Doxycycline, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

CA and Austria

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1733-11;

2) Fresh Frozen Plasma. Recall # B-1734-11

CODE

1) and 2) Unit: 2076869

RECALLING FIRM/MANUFACTURER

Hemacare Corp., Van Nuys, CA, by telephone on March 23, 2011 and by letter on March 31, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who previously tested HIV positive, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

NY, CA

___________________________________

PRODUCT

Source Plasma. Recall # B-1747-11

CODE

Unit: LT109376

RECALLING FIRM/MANUFACTURER

Pyramid Biological Corp. Las Vegas, NV, by facsimile on September 15, 2005. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Austria

___________________________________

PRODUCT

Recovered Plasma, Recall # B-1768-11

CODE

Unit: W035210002179Q

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Austria, TX, NC

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1781-11

CODE

Unit: 16KJ72174

RECALLING FIRM/MANUFACTURER

American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

OH, NJ, CA

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1785-11

CODE

Unit: W038111046791 (2 units)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by letter dated May 19, 2011.

Manufacturer: Florida's Blood Centers - Lake Worth, Palm Springs, FL. Firm initiataed recall is complete.

REASON

Blood products, which were stored at an unacceptable temperature, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

FL

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1798-11

CODE

Unit: W089211024609

RECALLING FIRM/MANUFACTURER

Sanford Medical Center (Blood Bank), Sioux Falls, SD, by facsimile on June 7, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

KY

___________________________________

PRODUCT

Source Leukocytes. Recall # B-1801-11

CODE

Unit: W035209132071U

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 24, 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

TN, TX