2010-07-31 | Welcome
Posted by Dave Cavenaugh   12-18-2007 WASHINGTON UPDATE
FDA Recalls Report Follows
COTT / NHF / HFA Open Letter on Safety

November 29, 2007


An Open Letter to the Manufacturers of Clotting Factor Products and the Government Agencies who Regulate Them:


Individuals affected by bleeding disorders depend on the availability of safe and efficacious clotting factor concentrates for their very lives. In the 1980s, the community was ravaged by the proliferation of HIV/AIDS and HCV tainted plasma derivatives. Many lessons were learned during that period about the importance of vigilance, and today we are fortunate to have an adequate supply of safe products, both recombinant and plasma-derived. However, recent events have created the perception that vigilance has started to wane.

The record of progress in addressing safety issues in recent years must not result in reduced vigilance as known and unknown pathogens continue to pose threats to the end users of clotting fuctor concentrates and our nation's blood supply. The need for vigilance never diminishes.

In the spirit of ongoing vigilance we are writing to express substantial community concern regarding recent issues that have potential implications for the safety of plasma derived clotting factor concentrates. Fortunately, the issues in question, which include but are not limited to cross-border plasma collection and regulatory violations at one collection center outlined in an FDA warning letter, did not result in tainted product or any other immediate danger to consumers. Nevertheless, there is genuine concern that these matters may not have initially been taken as seriously as they should have been. Furthermore, consumer organizations first learned of these issues from the media or other second-hand reports. We are appreciative of the recent efforts to provide us with answers to questions and other information addressing our concerns. However, our concerns do not end there, and neither should efforts to address them.

As organizations representing consumers with heightened sensitivities and, more importantly, critical vulnerability, we need a higher level of communication on an ongoing basis. In particular, we request the following:

1.       When an issue comes to light that may have implications for product safety on any level, we want to know about it - and by that we mean that we want direct, proactive communication.

 
2.       Communication should include an explanation of the problem itself, an analysis of its potential impact on product safety and patient health, and a description of the steps that are being taken to rectify it if necessary.

 
3.       Historically, issues of blood and blood product safety have been addressed on a site by site and/or event by event piecemeal basis. Although much progress has been made, what is ultimately needed is a national blood policy as exists in other countries. A national blood policy would provide an expanded regulatory framework within which many of the questions and issues we are identifying could be addressed in a more comprehensive and timely manner.

By working together to improve our vigilance and our communications around blood and product safety issues, we can all help ensure that safe, effective treatments will remain available for all who need them.


Sincerely,
Corey S. Dubin President, COTT
Carl Weixler President, HFA
Raymond W. Stanhope Chair of the Board, NHF
Mark W.Skinner President, WFH

 ==================================================

VIGILANCE

While recent reports on blood collection centers in three parts of the country have stirred the community to action, in the form of this joint letter, it is imperative that we as a community take monitoring of such things to a new level.  The following biologics-only sections of FDA Enforcement Reports (available weekly from www.fda.gov/opacom/7alerts.html ) illustrate why.  The first item listed contains by far the largest recall needed; most of the rest are for very few units – but scan down for REASONS and you may be startled to see that practice does not always equal standards.  These are just two weeks' worth of reports on known events.

Recent FDA CBER Biologics Enforcement Reports

December 12, 2007

PRODUCT
a) Baxter Closed System Apheresis Kit with PL 3014 Plastic Platelet Storage Containers;
    an Rx disposable sterile fluid pathway for platelet and plasma collection; catalog
    number 4R2180T, Recall # B-0152-08;
b) Baxter Fenwal Open System Apheresis Kit; an Rx disposable sterile fluid pathway
    for blood component collection; catalog number 4R2210T, Recall # B-0153-08;
c) Baxter Fenwal Closed System Apheresis Kit with restrictor tubing; an Rx disposable
    sterile fluid pathway for platelet and plasma collection; catalog number R4R2230T
    (multi-language label), Recall # B-0154-08;
d) Baxter Fenwal Open System Apheresis Kit with restrictor tubing; an Rx disposable
    sterile fluid pathway for blood component collection; catalog number R4R2210T,
    Recall # B-0155-08
CODE
a) Lot numbers N06D17034, N06D24022, N06D26027, N06E16025, N06E22023,
    N06F12022, N06F15017, N06H17027, N06H29022, N06I01029, N06I05020,
    N06I11028, N06I14014, N016I25028, N06J05011, N06J09021, N06J18022,
    N06J24012, N06J30019, N06K02024, N06K20026, N06K27039, N06L01024,
    N06L13029, N06L20016, N07A22013, N07A24027, N07B07020, N07B13028,
    N07C07028, N07C09016, N07C23025, N07D18015 *** N06A26023 ***;
b) Lot numbers N0521023, N05C01031, N05C06020, N05D12028, N05D15021,
    N05D20021N05E23022, N05E26025, N05F06017, N05F08021, N05F10027,
    N05G12021, N05G15024, N05J27024, N06A11025, N06A13021, N06A18020,
    N06B02022, N06B06023, N06B08029, N06B16022, N06C01022, N06C06021,
    N06C20022, N06C23026, N06C27027, N06D10021, N06E04021, N06E08022,
    N06F05018, N06G22029, N06G27028, N06G28034, N07A09010, N07B22011,
    N07C19023, N07C30020, N07D26018, N07D30010, N07E03014, N07E07023,
    N07E10027, N07E14037;
c) Lot numbers: N06A30017, N06C29023, N06F21023, N06G19025, N06H03027,
    N06H09024, N06J03024, N06K08021, N07B15015, N07B19025, N07D11010;
d) Lot numbers: N05F22022, N06I21027, N06K13039, N07B21013, N07D13016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Round Lake, IL, by telephone on June 20, 2007, and July 25, 2007 and by letters dated June 21, 2007 and July 10, 2007 and July 25, 2007.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, San German, PR. Firm initiated recall is ongoing.
REASON
Some of the CS3000 apheresis kits may have the ACD (anticoagulant) and saline lines misassembled. The reversed bag connections may not be visually apparent and could result in excessive ACD infusion and severe injury, including death, to the donor.
VOLUME OF PRODUCT IN COMMERCE: 92,761 kits
DISTRIBUTION: Nationwide and Internationally
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0090-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0091-08;
c) Blood and Blood Products for Reprocessing, Recall # B-0092-08
CODE
a) Unit: 4056551;
b) Units: 0237016; 4030291;
c) Units: 4056551; 0237016; 4030291
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by letter dated June 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE: 6 units
DISTRIBUTION: FL, NC, SC, and AL
___________________________________
PRODUCT
a) Platelets, Recall # B-0189-08;
b) Fresh Frozen Plasma, Recall # B-0190-08
CODE
a) and b) Units: LR70489
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by letter dated April 24, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information regarding multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0250-08
CODE
Unit: 71X453577
RECALLING FIRM/MANUFACTURER
Lifesouth Community Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on August 22, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0279-08
CODE: Unit: 71X391743
RECALLING FIRM/MANUFACTURER
Lifesouth Community Centers, Wiregrass Region, Dothan, AL, by facsimile on October 12, 2006. 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: AL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0280-08
CODE: Unit: 003LJ38759
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by facsimile on October 23, 2006. 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: GA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0361-08;
b) Platelets, Leukocytes Reduced, Recall # B-0362-08
CODE: a) and b) Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on May 10, 2007 and by letters dated May 14, 2007 and June 14, 2007. 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: OH, NC, and CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0363-08
CODE: Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on May 10, 2007 and by letters dated May 14, 2007 and June 14, 2007. 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: OH, NC, and CA


December 19, 2007


PRODUCT
Red Blood Cells, Recall # B-0246-08
CODE: Unit: 039E08083
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by letter dated July 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose sexual partner was positive for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: WV
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0348-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0349-08
CODE: a) and b) Units: 22KC93265
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on May 11, 2007 and by letter dated May 22, 2007. 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: PA
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0350-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0351-08;
c) Platelets Leukocytes Reduced, Recall # B-0352-08
CODE
a) Unit: 22KF66401;
b) Unit: 22KF66401, 22GL34395;
c) Unit: 22GL34395
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on May 9, 2007 and May 22, 2007, by facsimile or by letter dated May 23, 2007 and follow- up letters dated June 22, 2007. 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: 4 Units
DISTRIBUTION: CA, NJ, PA, and PR
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0354-08;
b) Platelets, Leukocytes Reduced, Recall # B-0355-08
CODE: a) and b) Unit: 22KT88518
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated April 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the Human Immunodeficiency Virus (HIV), but were collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: PA, NC
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0357-08;
b) Platelets, Leukocytes Reduced, Recall # B-0358-08
CODE: a) and b) Unit: 22LW89838
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on March 20, 22007 and by letter dated March 22, 2007. 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: PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0376-08
CODE: Unit: 71X391398
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by facsimile on September 15, 2006. 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: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0377-08
CODE: Unit: 71X447896
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on September 1, 2006
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: AL
___________________________________
PRODUCT
Source Plasma, Recall # B-0378-08
CODE
Units: 4120052997, 4120041309, 4120050379, 4120049362, 4120048885, 4120047943, 4120046261, 4120045848, 4120042317, 4120041954, 4120034592 and 4120033517
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Indianapolis, IN, by facsimile on May 9, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 12 units
DISTRIBUTION: IL, Germany and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0379-08
CODE
Unit: 2752585
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 12, 2006. 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: TX
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0380-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0381-08
CODE
a) Unit: 9408666;
b) Unit: 9410736
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: CO, NJ
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0382-08
CODE: it: 2090219
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 28, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: CO
___________________________________
PRODUCT
Platelets, Recall # B-0383-08
CODE: Unit: 2737912
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 14, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX
___________________________________
PRODUCT
Red Blood Cells, Apheresis Leukocytes Reduced, Recall # B-0406-08
CODE
Units: 22FM11946, 22GH37802
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated May 3, 2007. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: PA
___________________________________
PRODUCT
Plasma,, Frozen, Recall # B-0408-08
CODE: Unit: 2807831
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Terre Haute, IN, by telephone on March 24, 2007 and by letter dated April 26, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red blood cell unit that was found to contain clots during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: IN
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0415-08
CODE: Unit: 71X422908
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on July 17, 2006. Firm initiated recall was complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0416-08
CODE: Unit: 71X392715
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on July 10, 2006. 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: AL
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0417-08
b) Recovered Plasma, Recall # B-0418-08
CODE: a) and b) 02FV12222
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by telephone on March 15, 2006, by letter dated March 21, 2006, or by facsimile on March 17, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received a tattoo within 12 months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: TX, KY
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0432-08
CODE: Unit: 5996701
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 16, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0433-08
CODE: Unit: 2660665
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated April 25, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0434-08
CODE
Unit: 1620483
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated June 7, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: OH
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0435-08
CODE: Unit: 1653674
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated June 30, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: OH
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0436-08;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0437-08
CODE
a) Unit: 1956079;
b) Unit: 1956079 (split unit)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 26, 2006 and by letter dated July 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 3 units
DISTRIBUTION: TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0447-08
CODE: Unit: LP77077
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: WI
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0448-08
CODE: Unit: 2201594
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 26, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: KY
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0449-08
CODE
Units: 2084395 and 2122752
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letters dated August 12, 2005 and November 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: KY
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0450-08
CODE: Unit: 2136288
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated November 1, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: KY
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0451-08
CODE: Unit: 2620567
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated December 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0452-08
CODE: Unit: 71X199362
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on November 28, 2005. 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: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0453-08
CODE: Unit: 71X298468
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on December 28, 2005. 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: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0454-08
CODE: Unit: 71X299557 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on December 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
a) Platelets Pooled, Irradiated, Recall # B-0455-08;
b) Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0456-08;
c) Platelets Pheresis, Leukocytes Reduced, Recall # B-0457-08
CODE
a) LC70068 and FQ85764;
b) LJ34952;
c) LJ35065, KF07689, and GW12136
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date or time, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 6 units
DISTRIBUTION: WI
___________________________________
PRODUCT
Platelets, Recall # B-0458-08
CODE: Unit: 2641333
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on August 7, 2005. 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
a) Red Blood Cells, Recall # B-0459-08;
b) Fresh Frozen Plasma, Recall # B-0460-08;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-0461-08
CODE
a) Unit: LJ34298;
b) Unit: LJ34298, LC69203;
c) Unit: LC69203
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 22, 2005. 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: 4 units
DISTRIBUTION: WI, VA
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0462-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0463-08
CODE
a) Units: KL08388 and KL08286;
b) Unit: GR67720
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been stored under unacceptable storage conditions, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 3 units
DISTRIBUTION: WI
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0464-08
CODE: Unit: FQ84669
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on July 19, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been stored under unacceptable storage conditions, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: WI
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0473-08
CODE: Unit: M20693
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on June 27, 2007.
Manufacturer: Michigan Community Blood Centers, Bay City, MI. 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: MI
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0474-08
CODE: Unit: 3838744
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Terre Haute, IN, by telephone on July 10, 2007 and by letter on July 19, 2007. 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: IN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0475-08
CODE: Unit: Q06478
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on May 16, 2007.
Manufacturer: Michigan Community Blood Centers, Bay City, MI. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MI
___________________________________
PRODUCT
Platelets, Recall # B-0476-08
CODE: Unit: N59944
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on March 13, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MI
___________________________________
PRODUCT
Platelets, Recall # B-0477-08
CODE: Unit: N92515
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on June 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MI
___________________________________
PRODUCT
Platelets, Recall # B-0478-08
CODE: Unit: E24509
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on March 13, 2007.
Manufacturer: Michigan Community Blood Centers, Saint Joseph, MI. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood
component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MI
___________________________________
PRODUCT
Platelets, Leukocytes Reduced Irradiated, Recall # B-0480-08
CODE: Unit: W89836
RECALLING FIRM/MANUFACTURER
Costal Bend Blood Center, Corpus Christi, TX, by facsimile on February 13, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX
__________________________________
PRODUCT
Recovered Plasma, Recall # B-0353-08
CODE
Unit: 22KF66401, 22GL34395
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on May 9, 2007 and May 22, 2007, by facsimile or by letter dated May 23, 2007 and follow- up letters dated June 22, 2007. 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, NJ, PA, and PR
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0356-08
CODE
Units: 71R82459X and 71R827308
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 17, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance with the manufacturers instructions, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0360-08
CODE
Unit: 004KE55956 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by letter dated April 18, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a shingles vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: MA
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0384-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0385-08
CODE
a) Units: 2754393, 2751665 (1), and 2751665 (2);
b) Units: 2760187, 1760683, 2766956, 760182, 2767003, 2766990, 2753370,
    1728091, 2760188, 2754283, 2750680, 2761509, 2758530, 2767097, 2766987
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 29, 2006 and by letter dated January 4, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 18 units
DISTRIBUTION: TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0386-08
CODE: Unit: 2081541
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on September 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from an autologous donor with a history of hepatitis but was not labeled with a Biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0409-08
CODE
Units: 22GQ06569, 22LY95697
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated May 18, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as negative for the anti-C Red Blood Cell antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: PA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0414-08
CODE
Units: 71R54116X and 71R82547X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 17, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0430-8;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0431-08
CODE
a) Unit: 4009694;
b) Units: 0227576; and 4014451
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by letters starting April 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 3 units 
DISTRIBUTION: AL, GA, SC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0439-08.
CODE
Units: 71S639774 (split unit); 71S624693 (split unit); 71S62408X (split unit) ;71S639590 (split unit); and 71S623623 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers – Montgomery Region, Montgomery, AL, by facsimile on June 6, June 7, and June 15, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 10 units
DISTRIBUTION: AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0440-08
CODE
Unit: 71S040073 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0441-08
CODE
Unit: 71S043929 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0442-08
CODE
Unit: 71S040374 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0465-08
CODE: Unit: LK24212
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on October 10, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0479-08
CODE: Unit: 2180949
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 26, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: KY
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0481-08
CODE: Unit: W89836
RECALLING FIRM/MANUFACTURER
Costal Bend Blood Center, Corpus Christi, TX, by facsimile on February 13, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: TX

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Washington Update is a bi-monthly primer on government related issues of importance to COTT's constituency. From health care legislation, to regulatory affairs to Administration policy for chronic diseases. A hands-on journal for grass roots health care advocacy in our Nation's capital.

COTT News A range of information, reportage and viewpoints regarding issues and events of importance to grass roots health care advocacy and support. In COTTÂ’s vision information is power and part of the empowered community equation. From Washington D.C. to State capitals to the HIH and the FDA, look to COTT for grass roots health care news.

COTT Canary tracks safety issues in our Nation's blood supply. It provides regular reporting, information and viewpoints from the grass roots end user communities. It is based on the historical practice of taking Canaries into the coalmines to gauge problems with breathable air. If the Canary passed out then it was time to evacuate the mine. Persons with hemophilia and other bleeding disorders are the canaries in the coalmine, the blood supply. If problems are present they will surface first in the hemophilia community.

Treatment Updates: News, information and analysis about living with HIV/AIDS, hepatitis C, and hemophilia and related problems associated with living with multiple life threatening diseases.