OCTOBER 2009
WEEK ENDING OCTOBER 31
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 206635460, 208469162, 208469294, 208472611
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Baton Rouge, LA
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION LA
PRODUCT Recovered Plasma.
CODE Unit: GI58827
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Olympia, WA.
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
1 unit
DISTRIBUTION Austria
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: 19LW54232
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN
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 TN
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated;
2) Platelets Pheresis Leukocytes Reduced. CODE
1) Unit: W038309048380 ( part 1 and 2);
2) Unit: W038309048380
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA,
REASON
Blood products, labeled leukoreduced without the assurance that it met the
criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION IA, IL
PRODUCT Platelets Pooled
Leukocytes Reduced.
CODE Unit: 72Z272279
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL,
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells
Leukocytes Reduced.
CODE
Units: W036508101075, W036508101076, W036508101078, W036508101079, W036508101080
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA,
REASON
Blood products, which were tested for hematocrit using a device that failed
daily quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION LA, AR
PRODUCT
1) Platelets Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced. CODE
1) and 2) Unit: 22KE64381
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
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 Source
Plasma.
CODE Units: 3900049585, 3900049380
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Petersburg, VA,
REASON
Blood products, collected from a donor who received a tattoo within 12 months of
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION Austria
PRODUCT Source Plasma.
CODE
Units: 3880050687, 3880056039
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Aurora, IL,
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION Austria
PRODUCT Source
Plasma.
CODE Unit: TQ045947
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN,
REASON
Blood product, collected from a donor who was previously deferred, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit
DISTRIBUTION NC
PRODUCT
1) Source Leukocytes.
2) Red Blood Cells Leukocytes Reduced. 3) Plasma Frozen within 24 hours (FP24).
4) Platelets.
CODE
1) W044608427914;
2), 3) and 4) W044608427914, W044608639232
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood products, collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION TX, CA, NJ
PRODUCT
1) Red Blood Cells Leukocytes Reduced. 2) Liquid Plasma.
CODE 1) and 2) Units: W044608623287, W044609213820
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood products, collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION TX, NJ
PRODUCT Red Blood Cells
Leukocytes Reduced.
CODE Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA
Manufacturer: ARC Manchester, NH, Manchester, NH.
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 MA
PRODUCT Red Blood Cells
Leukocytes Reduced.
CODE
Units: 003LS45894, 003LS45901, 003LS45905
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region,
Douglasville, GA.
REASON
Blood products, collected using a machine for which the monthly quality control
testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION GA
PRODUCT
1) Repliform, Tissue Regeneration Matrix; 5 x 10 cm, .9-1.6 (mm); Order number
820245.
2) GraftJacket, Regenerative Tissue Matrix; 5 x 10 cm, Non-Meshed, Standard, .89-1.40 (mm) Order number 702050.
3) GraftJacket Maxforce-Extreme, Regenerative Tissue Matrix; 4x7 cm, 1.80-2.51 (mm) Reorder number: 702029.
4) GraftJacket Regenerative Tissue Matrix
Maximum Force, 5 x 5, 1.40 - 1.91 (mm) Reorder number: 702029.
CODE
1) Lot number B27803, sublots 20 and 21;
2) Lot number B28250, sublot numbers: 17 and 18 Lot number B28520, sublot number 13;
3) Lot number B28520, sublot numbers: 9, 10 Lot number B28892, sublot number 28;
4) Lot number: B28750, sublots: 42, 43; Lot
number: B28892, sublot # 33
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeCell Corp., Somerville, NJ,
Manufacturer: New England Organ Bank, Newton, MA.
REASON
Human Skin, recovered from donors with incomplete donor eligibility assessments,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION MA, TN
PRODUCT Human
Corneas.
CODE Units: SA20080231, SA20080232
RECALLING FIRM/MANUFACTURER
San Antonio Eye Bank, San Antonio, TX,
REASON
Human corneas, recovered from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION TX, FL
PRODUCT Red Blood Cells (Apheresis)
Leukocytes Reduced.
CODE Unit: W035809081385
RECALLING FIRM/MANUFACTURER
BloodSource, Inc, Mather, CA,
REASON
Blood product, which did not meet the requirement for red cell recovery, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT Recovered Plasma.
CODE Unit: 22KE64381
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
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 CA, PA
PRODUCT Recovered
Plasma.
CODE Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA
Manufacturer: ARC Manchester, NH, Manchester, NH.
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 CA
PRODUCT Recovered
Plasma.
CODE Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA
Manufacturer: ARC Manchester, NH, Manchester, NH.
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 CA
WEEK ENDING OCTOBER 24
PRODUCT
1) Cryoprecipitated AHF, Pooled.
2) Red Blood Cells Leukocytes Reduced. CODE
1) Unit: 5806277;
2) Unit: 6693677
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL,
REASON
Blood products, collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION FL
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 6253477
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON
Blood product, collected from a donor taking the drug Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: J72100 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA,
REASON
Blood products, collected from a donor who reported travel to a malarial endemic
area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION VA
PRODUCT Fresh
Frozen Plasma.
CODE Unit: 5166877
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ,
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
1 unit
DISTRIBUTION NJ
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 003KC31742
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA
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 GA
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 03R51462
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA,
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 AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 5000503
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA
REASON
Blood product, which was inappropriately distributed in a single storage bag,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION GA
PRODUCT Source
Plasma.
CODE Unit: 08MMTE0619
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT,
REASON
Blood product, collected from a donor who did not receive a physical examination
prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
Austria
DISTRIBUTION 1 unit
PRODUCT Source
Plasma.
CODE Unit: 08FWIE9698
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fond Du Lac, WI,
REASON
Blood product, collected from a donor who did not receive a physical examination
prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced Irradiated.
3) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 4661542;
2) Unit: 4654007;
3) Units: 4661542, 4648622
RECALLING FIRM/MANUFACTURER
Community Blood Bank, Inc., Rancho Mirage, CA,
REASON
Blood products, collected from a donor with a history of high risk behavior,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION CA
PRODUCT Source
Plasma.
CODE Unit: 08SPAC7187
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, State College, PA,
REASON
Blood product, collected from a donor who did not receive a complete physical
examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen within 24 hours
(FP24). CODE
1) and 2) Unit: W044608563638
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood products, which tested negative for the hepatitis C virus (HCV), but were
collected from a donor who previously tested reactive for HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION TX
PRODUCT Osteocel
Plus Cellular Bone Matrix, 1cc Nuvasive.
CODE
Lots: 091327107, 091327108, 091327009, 091327110, 091327111, 091327112,
091327105, 091327106, 091327113, 091327114, 091327115, 091327116, 091327117,
091327118, 091327103, 091327104, 091327119, 091327120, 091327121, 091327122,
091327123, 091327124, 091327125, 091327126, 091327127, 091327128, 091327129,
091327130
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO,
REASON
Osteocel Plus Ceullular Bone Matrix, recovered from a donor with a positive
Hepatitis B core Antibody serology result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
28 lots
DISTRIBUTION CA
PRODUCT 3
Cartilage allografts, mislabeled as 1) Patella Bone with Attachments ID;
091426-001, 2) Femoral Hemi Condyle Lateral Right, ID: 091426-0902, 3) Talus,
ID: 091426-003. CODE Units: 091246001, 091246002, 091246003
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO,
REASON
Tissue allografts, quarantined due to positive cultures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION AZ, KY, TX
PRODUCT Red Blood
Cells (Apheresis) Leukocytes Reduced.
CODE Unit: W226909911123 Part 2
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc, Richmond, VA,
REASON
Blood product, which exhibited signs of hemolysis within its segments, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION VA
PRODUCT Platelets.
CODE Unit: 7220688
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR,
REASON
Blood product, which was collected from a donor who had taken aspirin prior to
the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION OR
PRODUCT Source
Plasma.
CODE
Units: 08MIND1526, 08MIND1873, 08MIND2896, 08MIND3025, 08MIND4220, 08MIND4905,
08MIND5479, 08MIND6364, 08MIND6718, 08MIND7560, 08MIND7976, 08MIND8624,
08MIND9321, 08MIND9911, 08MINE0503, 08MINE1116, 08MINE1658, 08MINE2290,
08MINE3005, 08MINE3372 and 08MINE4188
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN,
REASON
Blood products, which were collected from a donor with a history of high risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. 2) Cryoprecipitated AHF, Pooled.
CODE
1) and 2) Unit: 003GP85930
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA,
Manufacturer: The American National Red Cross - Southern Region,
Douglasville, GA.
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 GA
PRODUCT Red Blood
Cells Leukocytes Reduced Irradiated.
CODE Unit: 003FR76355
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA
REASON
Blood product, which was not quarantined subsequent to receiving information
regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION GA
PRODUCT
1) Platelets.
2) Fresh Frozen Plasma.
3) Red Blood Cells Leukocytes Reduced Irradiated.
CODE 1), 2), and 3) Unit: 6710750
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK,
REASON
Blood products, collected from a donor who did not speak English, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION Alaska
PRODUCT Red Blood
Cells.
CODE Unit: M173437
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA.
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 WA
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: W043209004676
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN,
REASON
Blood product, labeled as leukoreduced, but which did not meet the criteria for
leukoreduced products, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TN
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72J516151
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Mobile, AL,
REASON
Blood product, with platelet count below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Units: W038309040925, W038309040852 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA,
REASON
Blood products, labeled leukoreduced without the assurance that it met the
criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION NC, IA, IL
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: W044208327399
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA
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 CA
PRODUCT Recovered
Plasma.
CODE Unit: 03R51462
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA,
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
1) Red Blood Cells Leukocytes Reduced. 2) Red Blood Cells Leukocytes Reduced
Irradiated.
CODE
1) Units: 5002281, 5002282, 5002288, 5002290, 5501408;
2) Units: 5501409, 5501410, 5501411
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Buffalo, NY,
REASON
Blood products, collected using scales that did not have complete daily QC
documentation, were distributed
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION NY
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 003L03982
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA
REASON
Blood product, collected from a donor whose donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION GA
PRODUCT Recovered
Plasma Cryoprecipitate Reduced.
CODE Unit: 003GP85930
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA,
Manufacturer: The American National Red Cross - Southern Region,
Douglasville, GA.
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 Source
Plasma.
CODE Unit: AQ030670
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC,
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 NC
PRODUCT Platelets.
CODE
Units: 7422757, 7422758, 7422762, 7422763, 7422765, 7422767, 7121021, 7121022,
7121024, 7121026, and 7121034
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR,
REASON
Blood products, which may have been exposed to unacceptable temperatures during
processing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION OR
WEEK ENDING OCTOBER 17
PRODUCT Ortho
ProVue, Product Code MTS213784.
CODE Software Versions 2.16 and below
RECALLING FIRM/MANUFACTURER
Recalling Firm: Micro Typing Systems, Inc., Pompano Beach, FL,
Manufacturer: Diagnostic Grifols, Parets Del Valles, Spain.
REASON Software, with an anomaly (Versions 2.16 and below)
affecting transmission of results from the Ortho ProVue using a bi-directional
Laboratory Information System (LIS) interface, was distributed.
VOLUME OF PRODUCT IN COMMERCE
558 units
DISTRIBUTION Nationwide and Canada
PRODUCT
1) Red Blood Cells, Leukocytes Reduced. 2) Plasma Frozen Within 24 Hours After
Phlebotomy (FP24).
CODE 1) and 2) Unit: W037909133936
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA,.
REASON
Blood products, collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION PA, NB
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K090262
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, with platelet count below the specified
minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Cornea.
CODE Units: CM117326OS, FM117326OD
RECALLING FIRM/MANUFACTURER
Michigan Eye-Bank, Ann Arbor, MI,
REASON
Human Corneal tissues, recovered from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION IL, MI
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Platelets Pooled Leukocytes Reduced Irradiated.
CODE 1) and 2) Unit: W141608399836
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA,
REASON
Blood products, collected from a donor who traveled to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION WA
PRODUCT Red Blood
Cells (Apheresis) Leukocytes Reduced.
CODE Units: W038308015093 (2 units)
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA,
REASON
Blood products, collected from a donor who lived in an HIV Group O risk area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MO
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: W036909924335 (Part 1)
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE,
REASON
Blood product, which exceeded the acceptable limit for platelet yield, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION DE
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 12C47179
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: American Red Cross Carolinas Blood Services Region,
Charlotte, NC. .
REASON
Blood product, which was labeled as negative for the C red cell antigen, but was
collected from a donor who subsequently tested positive for C antigen, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NC
PRODUCT Red Blood
Cells (Apheresis) Leukocytes Reduced.
CODE Units: 12KW19332 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: Double Red Cell Collections-Mobiles-Carolinas Region,
Winston-Salem, Winston Salem, NC.
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 NC
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 12L05824
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: American Red Cross Carolinas Blood Services Region,
Charlotte, NC.
REASON
Blood product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NC
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 8411962
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ,
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NJ
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen.
CODE 1) and 2) Unit: 12LS09353
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region,
Asheville, Asheville, NC.
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 NC
PRODUCT
1) Platelets. ;
2) Red Blood Cells.
CODE
1) Unit: 1689661;
2) Units: 1689661 and 1670944
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii,
REASON
Blood products, collected from a donor who traveled to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION Hawaii
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: 55H16904
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock,
AR,
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 AR
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K773675
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K761652
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K693927
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K737283
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Mobile, AL,
Manufacturer: LifeSouth Community Blood Centers, Montgomery Region,
Montgomery, AL.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Red Blood
Cells (Apheresis) Leukocytes Reduced.
CODE
Units: W0352090949241, W0352090949242
RECALLING FIRM/MANUFACTURER
Baylor University Medical Center Transfusion Services, Dallas, TX,
REASON
Blood products, which tested positive for red cell antigens, but were labeled as
testing negative for red cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72K505564
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL
PRODUCT Recovered
Plasma.
CODE Unit: 55H16904
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, .
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 CA
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Units: W036509084120, W036509084123, W036509084125, W036509084126,
W036509084110, W036509084112, W036509084113, W036509084114, W036509084115,
W036509084116, W036509084118, W036509084119
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA,
REASON
Blood products, collected from donors whose vital signs were measured using an
instrument that did not have annual quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION LA, AR
WEEK ENDING OCTOBER 10
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W141608139761
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA,
REASON
Blood product, which was collected from a donor who traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W14160817536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA.
REASON
Blood product, which was collected from a donor who traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
1) Platelets Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 22GG37361
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
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
PA
PRODUCT
Source Plasma.
CODE
Units: GA1249461; GA1249858; GA1250732; GA1251137
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM,
REASON
Blood products, which were collected from a donor with a history of high risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
United Kingdom
PRODUCT
Source Plasma.
CODE
Units: 0200008011, 0200008116, 0200008414, 0200011782, 0200011931, 0200012546,
0200012713, 0200012914, 0200013077, 0200013300, 0200013462, 0200014077,
0200014214, 0200014579, 0200014821, 0200015065, 0200015305, 0200015737,
0200016634, 0200016734, 0200016986, 0200017195, 0200017420, 0200017664,
0200017929, 0200018150, 0200018409, 0200018734, 0200019204, 0200019305,
0200019731. 0200020245, 0200020344, 0200020696, 0200021104, 0200021560,
0200021928, 0200022294, 0200022482, 0200022715, 0200022924, 0200023174,
0200023710, 0200024030, 0200024325, 0200024658
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Los Angeles, CA,
Manufacturer: Biomat USA, Inc., Macon, GA.
REASON
Blood products, collected from a donor whose physical examination was overdue,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Spain
PRODUCT
Source Plasma.
CODE
Units: 0200037197, 0200037654, 0200037722, 0200046739, 0200046983, 0200047315,
0200047855, 0200048069, 0200048396, 0200048578, 0200048890, 0200049323,
0200049490, 0200049795, 0200050121, 0200050461, 0200050723, 0200051121,
0200051320, 0200053821, 0200054007, 0200054422, 0200054665, 0200054850,
0200055046, 0200055236, 0200055660, 0200055881, 0200056386
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Macon, GA,
REASON
Blood products, collected from a donor who received tattoos within 12 months of
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Spain
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 12GE85971;
2) Units: 12KE02270; 12LV43994
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Wilmington,
Wilmington, NC.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
PRODUCT
1) Red Blood Cells.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 007FX24319;
2) Units: 007FH52656, 007FR34317, 007FR34321, 007FR34323, and 007FY80264
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ,
REASON
Blood products, collected in a manner that may compromise the sterility of the
collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen.
CODE
1) and 2) Unit: 12KQ60542
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Charlotte, NC,
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
NC
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: W047009259584
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ,
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
NY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W036509005829
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA,
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
LA
PRODUCT
Red Blood Cells.
CODE
Unit: 5034562
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC,
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
SC
PRODUCT
1) Plasma Frozen.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: W087608022985;
2) Units: W087608820904, W087608022985, W087609020660
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA,
REASON
Blood products, collected from a donor who was previously deferred for testing
positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA
PRODUCT
Source Plasma.
CODE
Units: 4590020140, 4590019964, 4590019490, 4590019270, 4590018818, 4590018608,
4590018131, 4590017894, 4590022205, 4590021525, 4590021310, 4590020785,
4590020587
RECALLING FIRM/MANUFACTURER
Life Sera, Jacksonville, FL,
REASON
Blood products, collected from a donor whose scheduled physical exam was
incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Austria
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W044608570561 (2 units)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood products, collected from a donor who traveled to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
PRODUCT
1) Fresh Frozen Plasma (Apheresis),
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Unit: W087609047378;
2) Unit: W087609047848
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA,
REASON
Blood products, for which the sterility may have been compromised, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma, Frozen.
CODE
1) Units: 20M50010, 20M56364, 20M56368;
2) Unit: 20M56364
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
ID, UT
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: 35S71537 (double collection)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA,
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV, VA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
3) Platelets.
CODE
1), 2), and 3) Unit: W0352090905379
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood products, collected from a donor who had received a piercing within one
year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced.
2) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated.
CODE
1) and 2) Unit: W041009035604L
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, Scottsdale, AZ,
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
PRODUCT
Recovered Plasma.
CODE
Unit: 22GG37361
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
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.
CODE
Unit: 12GY10762
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: American Red Cross Carolinas Blood Services Region, Charlotte, NC.
REASON
Blood product, manufactured without additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Recovered Plasma.
CODE
Units: 12GE85971, 12KE02270; 12LV43994
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC,
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Wilmington,
Wilmington, NC.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
PRODUCT
Source Plasma.
CODE
Unit: AQ030601
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC,
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
NC
PRODUCT
1) Red Blood Cells.
2) Platelets.
CODE
1) and 2) Unit: W120608420429
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI,
REASON
Blood products, collected from a donor who was at risk for Chagas disease, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
PRODUCT
Recovered Plasma.
CODE
Unit: W087609020660
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA
REASON
Blood product, collected from a donor who was previously deferred for testing
positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
PRODUCT
Source Plasma.
CODE
Units: LZ112629, LP063784
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., Mo, Saint Louis, MO,
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, Germany
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 3505086, 3505084
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Buffalo, NY,
REASON
Blood products, collected using scales for which the quality control testing was
not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
PRODUCT
1) Recovered Plasma.
CODE
Units: 20M50010, 20M56368
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
1) Units: W035208179231T, W035208207452A, W0352082099820;
2) Unit: W035209001156B (2 units)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood products, which did not meet the requirement for red blood cell recovery,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX
WEEK ENDING OCTOBER 3
PRODUCT
1) Fresh Frozen Plasma
2) Red Blood Cells Leukocytes Reduced. CODE
1) and 2) Unit: 06LT57392
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA,
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) Platelets Pheresis Leukocytes Reduced.
2) Platelets Pheresis Leukocytes
Reduced Irradiated.
1) Units: W1416082539912, W1416082532401, W1416082518332, W1416082515531,
W1416082508352;
2) Units: W1416082547421,
W1416082547422, W1416082539911, W1416082532402, W1416082518331, W1416082515532,
W1416082508351, W1416082506271, W1416082506272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Federal Way, WA.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Units
DISTRIBUTION WA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2)
Fresh Frozen Plasma,
CODE
1) Unit: 19GH87696;
2) Units: 19LF36484; 19LW53579
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION TN
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: W142808308609
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA,
Tri-Counties Blood Bank, San Luis Obispo, CA.
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2)
Recovered Plasma.
CODE 1) and 2) W035809092879, W035808150661
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA,
REASON
Blood products, collected from a donor with a history of receiving an accidental
needle stick, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION CA, Switzerland
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit: W045209009550
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN,
REASON
Blood product, which was labeled as leukoreduced, but exceeded the acceptable
limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION IN
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit: 54KC14605
RECALLING FIRM/MANUFACTURER
American National Red Cross, Rio Piedras PR,
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 PR
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2)
Fresh Frozen Plasma.
3) Platelets.
CODE 1), 2), and 3) Unit: W035209092847N
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood products, collected from a donor for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Units: W044209514562, W044209482728
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA,
REASON
Blood products, which were inappropriately distributed in single storage bags,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2)
Cryoprecipitated AHF.
CODE 1) and 2) Unit: W035209081823D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
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
PRODUCT
1) Cryoprecipitated AHF.
2) Red Blood Cells Leukocytes Reduced.
3)
Red Blood Cells Leukocytes Reduced Irradiated.
4) Recovered Plasma.
CODE
1) and 3) Unit: 5555616;
2) Unit: 2295323;
4) Units: 2295323, 5555616
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA,
REASON
Blood products, collected from a donor considered to be at increased risk for
variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION ID, WA, Austria
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Red Blood Cells Leukocytes Reduced. CODE
1) W047009333929; W047008711829; W047008285704;
2) W047009194219; W047009334118; W047009334872; W047009194643; W047009269357;
W047008545387; W047009164706; W047008291737; W047008572879; W047008099613
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island, NY,
REASON
Blood products, processed from overweight units of Whole Blood, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION NJ, NY
PRODUCT Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), FOR
PEDIATRIC USE ONLY, Disposable Syringe, One Dose (0.5mL) IM NDC 0005-1970-49
(single dose 0.5mL pre-filled syringe), RX only, CONTAINS NO PRESERVATIVE, and
carton labeled NDC 0005-1970-50 Wyeth, FOR PEDIATRIC USE ONLY, Pneumococcal
7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevnar, FOR
INTRAMUSCULAR USE ONLY, RX only,10 One Dose (0.5mL)Disposable Syringes and One
carton contains 10 single dose (0.5mL) pre-filled syringes. This is shipped 45
cartons of 10 x 1(0.5mL) single dose pre-filled syringes per shipper.
CODE Lot D50002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA,
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY.
REASON
Prevnar Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes
not intended for commercial use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
96,280 doses
DISTRIBUTION Nationwide, North Mariana Islands, Guam and US
Virgin Islands
PRODUCT Recovered
Plasma.
CODE Unit: 19GH87696
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
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.
CODE Unit: W035809106252
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA,
REASON
Blood product, manufactured without the entire quantity of additive solution,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT Source
Leukocytes.
CODE Unit: W035209092847N
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
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 TX
PRODUCT Recovered
Plasma.
CODE Unit: W035209081823D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
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
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Units: 20GZ16275, 20GZ16277, 20GZ16278, 20GZ16286, 20GZ16285, 20GZ16287,
20GZ16292, 20GZ16300, 20GZ16281, 20GZ16309, 20GZ16276, 20GZ16279, 20GZ16298,
20GZ16307, 20GZ16274, 20GZ16282, 20GZ16284, 20GZ16295, 20GZ16302, 20GZ16303,
20GZ16306, 20GZ16293, 20GZ16294, 20GZ16304, 20GZ16305
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Boise, ID,
Manufacturer: American National Red Cross, Great Falls, MT.
REASON
Blood products, collected during equipment validation but which did not pass the
required QC testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION MT