JANUARY 2012
WEEK ENDING JANUARY 28
PRODUCT
1) Cryoprecipitated AHF, Pooled.
2) Plasma Frozen within 24 hours
(FP24).
3) Red Blood Cells Leukocytes
Reduced.
CODE
1) Unit: 6571965;
2) Units: 6568228; 6548844;
3) Units: 6568228; 6571965;
6548844
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue
Center, San Antonio, TX,
REASON
Blood Products, in which NAT
re-entry testing was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
PRODUCT
Fresh Frozen Plasma.
CODE
Unit: W115111254817P
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers,
Inc., Dunwoody, GA,
REASON
Blood product, collected from a
donor who may have been at risk for variant Creutzfeldt-Jakob disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Unit: W1151112548747
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers,
Inc., Dunwoody, GA,
REASON
Blood product, collected from a
donor who may have been at risk for variant Creutzfeldt-Jakob disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Unit: W038111209567
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc.,
Orlando, FL,
REASON
Blood product, collected from a
donor with Polycythemia Vera, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W038511383332
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood
Center, Inc., Augusta, GA,
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
PRODUCT
Red Blood Cells (Apheresis).
CODE
Units: W038111270732;
W038111270764
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers - Lake
Park, Palm Beach Gardens, FL,
REASON
Blood products, labeled 'leukoreduced',
but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Recovered Plasma.
CODE
Unit: W333610045499
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional
Building Center, Davenport, IA
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
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Unit: W158011200769
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy,
UT,
REASON
Donor Screening/Donor gave history
which warranted deferral or follow up and was not deferred or follow up
questions were not asked.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Recovered Plasma.
2) Red Blood Cells Leukocytes
Reduced.
3) Cryoprecipitated AHF.
4) Fresh Frozen Plasma.
5) Plasma Frozen Cryoprecipitated
Reduced.
CODE
1) Units: 1811150, 1808269,
1711496, 1708784;
2) Units: 1811150, 1808269,
1711496, 1710737, 1708784, 1617461;
3) Unit: 1617461;
4) Unit: 1710737;
5) Unit: 1617461
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center,
Spokane, WA,
REASON
Blood products, collected from a
donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
WA, ID, FL, Austria
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Units: 6725862, 6527837
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc.,
Anchorage, AK,
REASON
Blood products, collected from a
donor who received human growth hormone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Red Blood Cells (Apheresis)
Leukocytes Reduced.
CODE
Unit: W068508345996
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center,
Spokane, WA,
REASON
Blood product, which had a low
hemoglobin level, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: 2700787
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc.,
Anchorage, AK,
REASON
Blood product, collected from a
donor who was taking the medication Tazorac, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Recovered Plasma.
CODE
Unit: W141607534804
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and
Program, Seattle, WA,
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
PRODUCT
Recovered Plasma.
CODE
Unit: W141607116996
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Bellingham, WA.
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
PRODUCT
Platelets Pheresis Leukocytes
Reduced Irradiated.
CODE
Units: W1416081301061,
W1416081301062
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
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Units: 20FK26699, 20FK26976
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American
National Red Cross, Boise, ID,
Manufacturer: American National
Red Cross, Kalispell, MT.
REASON
Blood products, collected from a
donor for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Red Blood Cells Leukocytes Reduced
Irradiated.
CODE
Unit: W141608390988
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and
Program, Seattle, WA,
REASON
Blood product, collected from a
donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W141608390560
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and
Program, Seattle, WA,
REASON
Blood product, collected from a
donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W141607418998
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Bellevue, WA. .
REASON
Blood product, collected from a
donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Fresh Frozen Plasma.
CODE
Unit: W141607492522
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 who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W036811072727
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida
Inc., Lauderhill, FL,
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
Switzerland, FL
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Units: W038111042394,
W038110357267
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc.,
Orlando, FL,
REASON
Blood products, collected from a
donor who emigrated from an area considered endemic for malaria and received a
tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Unit: 27KW39921
RECALLING FIRM/MANUFACTURER
American Red Cross Greater
Alleghenies Region, Johnstown, PA,
REASON
Blood product, manufactured
without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W051511055528
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood
Centers, Saint Paul, MN,
Manufacturer: Memorial Blood
Centers – Duluth, Duluth, MN.
REASON
Blood product, collected from a
donor with Hemachromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells Leukocytes
Reduced.
CODE
Units: W333611089675;
W333611088459
RECALLING FIRM/MANUFACTURER
Mississippi Valley Region Building
Center, Davenport, IA,
REASON
Blood products, manufactured
without the entire quantity of additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Recovered Plasma.
CODE
Units: 6725862, 6527837
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc.,
Anchorage, AK,
REASON
Blood products, collected from a
donor who received human growth hormone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Red Blood Cells Leukocytes Reduced
Irradiated.
CODE
Unit: W141608044018
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Tukwila, WA.
REASON
Blood product, collected from a
donor for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Source Plasma.
CODE
Unit: 07GMTE2718
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P.,
Great Falls, MT,
REASON
Blood product, collected from a
donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Platelets.
CODE
Unit: W141608132802
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and
Program, Seattle, WA,
REASON
Blood product, collected from a
donor for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
Red Blood Cells.
CODE
Unit: W141608393162
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and
Program, Seattle, WA,
REASON
Blood product, collected from a
donor for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Recovered Plasma.
2) Plasma Frozen.
CODE
1) Unit: 20FK26699;
2) Unit: 20FK26976
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American
National Red Cross, Boise, ID,
Manufacturer: American National
Red Cross, Kalispell, MT.
REASON
Blood products, collected from a
donor for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
Recovered Plasma.
CODE
Unit: W036811072727
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida
Inc., Lauderhill, FL,
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
Switzerland, FL
WEEK ENDING JANUARY 21
PRODUCT
1) Tendon, Human tissue for
transplantation, labeled in part ***Anterior Tibial Tendon***Posterior Tibial
Tendon***Semi-Tendinosus Tendon***Peroneus Longus Tendon***and ***Pre-Shaped
Achilles.Ten 10***.
2) Cardiac Tissue, Non-valved.
3) Ligament, Human Tissue for
Transplantation, labeled in part ***Bisected Pat.Ligament***. ;
4) Bone, Human Tissue for
Transplantation, labeled in part ***Cerv 4 Deg W/Plug 7***Cancellous 20 (1-4
mm)***Cancellous (1-4 mm)***Tricort Can Wedge***and ***Fibular Segment
100***.
CODE
1) Lot/Serial number: 11116610007,
11116610008, 11116610009, 11116610010, 11116610011, 11116610012, 11116610016;
2) Lot/Serial number: 11116610001;
3) Lot/ Serial Number:
11116610014, 11116610015;
4) Lot/Serial numbers:,
11116610018, 11116610019, 11116610020, 11116610021, 11116610022, 11116610023,
11116610024, 11116610025, 11116610026, 11116610027, 11116610028, 11116610029,
11116610030, 11116610031, 11116610032, 11116610033, 11116610035, 11116610036,
11116610037, 11116610038, 11116610039, 11116610040, 11116610041, 11116610042,
11116610043, 11116610044, 11116610045, 11116610046, 11116610047, 11116610048,
11116610049, 11116610050, 11116610051, 11116610052
RECALLING FIRM/MANUFACTURER
LifeNet Health, Virginia Beach,
VA,
REASON Human
tissue allografts, recovered from a donor where infections disease testing was
incorrectly performed and recipients are at increased risk for disease
transmission, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 tissues
DISTRIBUTION VA,
AZ, TX, PA, SC, MA, NC, IN and NM
PRODUCT Source
Plasma.
CODE Unit:
11YARB7188
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP,
Fayetteville, AR,
REASON Blood
product, collected from a donor who did not respond to questions regarding
increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Source
Plasma
CODE Unit:
11MOHC3278
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima,
OH,
REASON Blood
product, collected from a donor who did not respond to questions regarding
increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Red Blood Cells.
2) Recovered Plasma.
CODE 1)
and 2) Unit: W141608614712
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Bellevue, WA.
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
PRODUCT Platelets
Pooled Leukocytes Reduced.
CODE Unit:
W141608436796
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Lynnwood, WA.
REASON Blood
products, collected from a donor who reported a history of hepatitis after age
11, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Platelets Pooled Irradiated. ;
2) Red Blood Cells Leukocytes Reduced
Irradiated.
CODE
1) Unit: W141608002990;
2) Units: W141608010161AO;
W141608010161BO; W141608006054; W141608002990
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Bellevue, WA.
REASON Blood
products, collected from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
PRODUCT Red
Blood Cells.
CODE Unit:
W141608593923
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program,
Seattle, WA
REASON Blood
product, collected from a donor who traveled to a high risk area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Platelets Pooled Leukocytes Reduced
Irradiated.
2) Red Blood Cells.
3) Fresh Frozen Plasma.
CODE 1),
2), and 3) Unit: W141608472927
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA,.
Manufacturer: Puget Sound Blood
Center and Program, Everett, WA.
REASON Blood
products, collected from a donor who received a piercing within 12 months of
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced.
CODE Unit:
8034913 (part 1), 8034913 (part 2)
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA,
REASON Blood
products, collected from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Units:
8708665, 6633367
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA,
REASON Blood
products, which should have been quarantined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
1) Red Blood Cells Leukocytes
Reduced.
2) Red Blood Cells.
3) Red Blood Cells Leukocytes Reduced
Irradiated.
CODE
1) Units: W141608214622; W141607217576;
2) Unit: W141607219445;
3) Unit: W141608210450
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA, .
Manufacturer: Puget Sound Blood
Center and Program, Lynnwood, WA.
REASON Blood
products, collected from a donor taking the medication Finasteride, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION WA,
CA, Austria
PRODUCT Source
Plasma.
CODE
Units: 3300179094, 3300178621,
3300177344, 3300176839, 3300173636, 3300172778, 3300172269, 3300171536,
3300170743, 3300170508, 3300169615, 3300169080, 3300168184, 3300167741,
3300162100, 3300161679, 3300160919, 3300160185, 3300159547, 3300158681,
3300158229, 3300155643, 3300155312, 3300153947, 3300153110, 3300152205,
3300151111, 3300150391, 3300149710, 3300149168, 3300148642, 3300148046,
3300147458, 3300143851, 3300143465, 3300142803, 3300142037, 3300141615,
3300140544, 3300139883, 3300139413, 3300138486, 3300137748, 3300137101,
3300135913, 3300134920, 3300131704, 3300130865, 3300130239, 3300125878,
3300125614, 3300124352, 3300123945, 3300122776, 3300121197, 3300120816,
3300119359
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc.,
Saginaw, MI,
REASON Blood
products, collected from a donor who received a piercing within 12 months of
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units
PRODUCT Source
Plasma.
CODE Unit:
0370724689
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Medford, OR,
REASON Blood
product, collected from a donor in which donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells.
CODE Unit:
W141607378009
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program,
Seattle, WA,
REASON Blood
product, that lacked assurance of being stored at proper temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated.
CODE Unit:
0935330B0
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane,
WA,
REASON Blood
product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells.
CODE Unit:
W141607534462
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA
Manufacturer: Puget Sound Blood
Center and Program, Tukwila, WA.
REASON Blood
products, which was collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Red Blood Cells Leukocytes
Reduced.
2) Recovered Plasma.
CODE 1)
and 2) Unit: Unit: W137511110369
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene,
OR,
REASON Blood
products, collected from a donor who received a tattoo within 12 months of
donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
01GH50379
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American
National Red Cross, West Henrietta, NY,
Manufacturer: The American
National Red Cross, Albany, NY.
REASON Blood
Product, collected from a donor whose donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
12KP02192
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American
National Red Cross, Carolinas Region, Charlotte, NC,
Manufacturer: American Red Cross
Blood 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
PRODUCT Source
Plasma.
CODE Units:
11GINA9495; 11GINA9496; 11GINA9497; 11GINA9498; 11GINA9499; 11GINA9500;
11GINA9501; 11GINA9502; 11GINA9503
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary,
IN,
REASON Blood
products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
PRODUCT
1) Red Blood Cells Leukocytes Reduced
Irradiated.
2) Red Blood Cells Leukocytes
Reduced.
CODE
1) Unit: W141607020399;
2) Unit: W141608002859
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood
Center, Bellevue, 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
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
W036311013516
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc.,
Milwaukee, WI,
REASON Blood
product, which contained antibodies but was not labeled as positive for
unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Unit:
041LG95907
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red
Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross
Blood Services, Alabama Region, Huntsville, AL.
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Units:
W141608214622; W141607217576
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Lynnwood, WA. .
REASON Blood
products, collected from a donor taking the medication Finasteride, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION WA,
CA, Austria
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit:
W224308305444
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield,
CA,
REASON Blood
product, which did not meet shipping time frame, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit:
021KT33298
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National
Red Cross, Lewis and Clark Region, Salt Lake City, UT,
Manufacturer: American National
Red Cross, Boise, ID.
REASON Blood
product, which may have reached an unacceptable temperature during shipment,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Plasma
Frozen within 24 hours (FP24).
CODE Unit:
35FV26135
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater
Chesapeake & Potomac Region, Baltimore, MD,
REASON Blood
product, documented as being out of controlled storage for more than 30
minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered Plasma.
CODE Unit:
01GH50379
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National
Red Cross, West Henrietta, NY,
Manufacturer: The American
National Red Cross, Albany, NY.
REASON Blood
Product, collected from a donor whose donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced.
CODE Units:
53GN95753PT1; 53GN95753PT2
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater
Chesapeake & Potomac Region, Baltimore, MD,
REASON Blood
products, collected from a donor whose hemoglobin was determined using a
Hemocue that failed daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MD,
KY
WEEK ENDING JANUARY 14
PRODUCT Source
Plasma.
CODE
Units: 07KINF3436, 07KINF5486,
07KINF6442, 07KINF6927, 07KINF7851, 08KINA1752, 08KINA3645, 08KINA4233,
08KINA4920, 08KINB0194, 08KINB0669, 08KINB2027, 08KINB2573, 08KINB3415,
08KINB3697, 09KINA6864, 09KINA7406, 09KINA8424, 09KINB0489, 09KINB1076,
09KINB1907, 09KINB2500, 09KINB3375, 09KINB4335, 09KINB5012, 09KINB5897,
09KINB6857, 09KINB7567, 09KINB5820, 09KINC3232, 09KINC3617, 09KINC5027,
09KINC6038, 09KINC7881, 09KINC8444, 09KINC9495, 07KIND5142, 07KIND6161,
07KIND6664, 07KINF8412, 07KING8746, 07KING9889, 08KINA9032, 08KINA9411,
08KINB4643, 08KINB5084, 08KINB5900, 08KINB6666, 08KINB7146, 08KINB7974,
08KINB9035, 08KINB9431, 08KINC0207, 08KINC1647, 08KINC3255, 08KINC3865,
08KINC4764, 08KINC5901, 08KINC6222, 08KINC7377, 08KINC8171, 08KINC8894,
08KINC9322, 08KIND1033, 08KIND1524, 08KIND2226, 08KIND2580, 08KIND3360,
08KIND3984, 08KIND4845, 08KIND5427, 08KIND6129, 08KIND6882, 08KIND8385,
08KIND8999, 08KINE0275, 08KINE0930, 08KINE2158, 08KINE2600, 08KINE3466,
08KINE3834, 08KINE4644, 08KINE6074, 08KINE6810, 08KINE7555, 08KINE8307,
08KINE8892, 08KINE9794, 08KINF0222, 08KINF1066, 08KINF1543, 08KINF2186,
08KINF2773, 08KINF8614, 08KINF9750, 08KING0123, 08KING1511, 08KING1696,
08KING3079, 08KING4351, 09KINA0934, 09KINA1632, 09KINA2281, 09KINA3014,
09KINA5513, 09KINA6020, 08KINA1333
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma
Services L.P., Deerfield, IL, .
Manufacturer: BioLife Plasma
Services L.P., Kokomo, IN.
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
107 units
PRODUCT
1) Red Blood Cells Leukocytes Reduced
Irradiated.
2) Red Blood Cells.
3) Red Blood Cells Leukocytes
Reduced.
4) Platelets Pheresis Leukocytes Reduced
Irradiated.
CODE
1) Unit: W141607086940;
2) Unit: W141607134612;
3) Unit: W141607132693;
4)Units: W141607982838; W141607083042
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle,
WA,
REASON Blood
products, collected from a donor who reported travel to an area possibly
endemic for malarial, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
239659474
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems
Inc., Scottsdale, AZ.,
Manufacturer: Blood Systems,
Inc., Billings, MT.
REASON Blood
product, collected from a donor who reported post donation illness, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Units:
7086090 (1); 7086090 (2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood
Center, inc-cellular Therapy Laboratory, New York, NY,
Manufacturer: New York Blood
Center, Inc., Westbury, NY.
REASON Blood
products, possibly contaminated with Bacillus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
1) Cryoprecipitated AHF.
2) Red Blood Cells Leukocytes Reduced.
CODE 1)
and 2) Unit: 9324820
RECALLING FIRM/MANUFACTURER
Northern California Community Blood
Bank, Eureka, CA,
REASON Blood
products, collected from a donor taking the drug Azulfidine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:06LZ12731
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,
CA,
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT
1) Red Blood Cells Leukocytes
Reduced.
2) Plasma Frozen.
CODE 1)
and 2) Unit: 06GN76586
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,
CA,
REASON Blood
products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT
1) Red Blood Cells Leukocytes
Reduced.
2) AS-3 Red Blood Cells Leukocytes
Reduced Adenine-Saline Added.
CODE
1) Units: 032FT28488; 032GC74141;
032GC74437; 032GC74608; 032GJ05008; 032GJ05112; 032GN89985; 032GN90057;
032GN90078; 032GN90094; 032GN90187; 032GN90272; 032GN90295; 032GN90297;
032GN90301; 032GN90313; 032GN90638; 032GN90075; 032GN90729; 032GN90881;
2) Units: 032GH14473, 032GH14473
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Madison, WI,
REASON Blood
products, collected from donors, whose suitability to donate were not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
WI, IL, TN, GA. SC, PA
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
06GJ95801
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,
CA,
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
PRODUCT Source
Plasma.
CODE
Units: 4600077917; 4600077652;
4600077230; 4600076138; 4600075737; 4600075018; 4600074069; 4600073360;
4600072669; 4600072269; 4600070307; 4600070047; 4600069629; 4600068193;
4600067940; 4600067520; 4600067284; 4600071417; 4600064724; 4600058109;
4600057841; 4600057445; 4600057165; 4600056686; 4600056424; 4600055979;
4600055686; 4600055166; 4600054910; 4600054353
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Salt Lake City,
UT,
REASON Blood
products, collected from a donor whose scheduled physical examination was
incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
PRODUCT Fresh
Frozen Plasma.
CODE Unit:
06FS06803
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA,
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
PRODUCT
1) Cryoprecipitated AHF.
2) Recovered Plasma.
CODE
1) Units: 8324252, 8322169, 8326106;
2) Units: 8326106, 8324252, 8322169,
6399450, 6396748
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northern
California Community Blood Bank, Eureka, CA,
Manufacturer: Central California
Blood Center, Fresno, CA.
REASON Blood
products, for which viral testing was performed using an invalid sample, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION CA,
FL, Austria
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
W141608190893
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Silverdale, WA.
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Unit:
W141606001436
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood
Center, Seattle, WA,
Manufacturer: Puget Sound Blood
Center and Program, Bellevue, 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
PRODUCT Red
Blood Cells.
CODE Unit:
W141608391566
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program,
Seattle, WA,
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: 2705404
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage,
AK,
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
20FE04714
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and
Clark Region, Salt Lake City, UT, .
Manufacturer: American National
Red Cross, Missoula, MT.
REASON Blood
product, which was collected from a donor who lived in a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Unit:
V71842
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma,
WA,
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
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Units: 40FP39865 - part 1, 40FP39865 -
part 2, 40FP39875 - part 1, 40FP39875 - part 2, 40FP39879 - part 1, 40FP39879
- part 2, 40FP39879 - part 3, 40FP39884 - part 3, 40FP39889 - part 1,
40FP39889 - part 2, 40FP39889 - part 3, 40FP39893 - part 1, 40FP39893 - part
2, 40FP39893 - part 3
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of
America Region, Peoria, IL,
REASON Blood
products, which were collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
PRODUCT Flow
PRA Class I Positive Control Serum.
CODE Lot
Numbers: 7.1
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA,
REASON Flow
Class I and II Positive Control Serums, with incomplete or positive infectious
disease testing, as required for human source components for use in vitro
diagnostic products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8,147 Units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Units: 20FM47523, 20FM47524, 20FM47525,
20FM47526, 20FM47527, 20FM47528, 20FM47529, 20FM47530, 20FM47531, 20FM47533,
20FM57534, 20FM47535, 20FM47536, 20FM47537, 20FM47538, 20FM47539, 20FM47540,
20FM47541, 20FM47542, 20FM47543, 20FM47544, 20FM47545, 20FM47546, 20FM47547,
20FM47548, 20FM47550, 20FM47551, 20FM47552, 20FM47553, 20FM47555, 20FM47556,
20LN91806, 20LN91807, 20LN91808, 20LN91809, 20LN91810, 20LN91811, 20LN91812,
20LN91813, 20LN91814, 20LN91815, 20LN91816, 20LN91818, 20LN91819, 20LN91820,
20LN91822, 20LN91823, 20LN91824, 20LN91825, 20LN91826, 20LN91827, 20LN91828,
20LN91829, 20LN91830, 20LN91831, 20LN91832, 20LN91833, 20LN91834, 20LN91835,
20LN91837, 20LN91838, 20LN91839, 20LN91840, 20LN91841, 20LN91843, 20LN91844,
20LN91846, 20LN91847, 20LN91848, 20LN91849, 20LN91850, 20LN91851, 20LN91853,
20LN91854, 20LN91855, 20LN91856, 20LN91858, 20LN91859, 20LN91860, 20LN91861,
20LN91862, 20LN91863, 20LN91864, 20LN91865, 20LN91866, 20LN91867, 20LN91869,
20LN91871, 20LN91872, 20LN91873, 20LN91874, 20LN91875, 20LN91876, 20LN91877
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt
Lake City, UT
REASON Blood
products, manufactured from Whole Blood, which may have been exposed to
unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION CA,
ID, MT, UT, WA
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
9964888
RECALLING FIRM/MANUFACTURER
Northern California Community Blood
Bank, Eureka, CA,
REASON Blood
product, manufactured without the entire amount of red cell preservative
solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Source
Plasma.
CODE Units:
3300037479, 3300037481, 3300037476, 3300037490, 3300037492, 3300037494,
3300037502, 3300037516, 3300037533, 3300037557, 3300037571, 3300037570, and
3300037574
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc.,
Saginaw, MI,
REASON Blood
products, exposed to unacceptable storage temperatures and not relabeled as
Source Plasma, Salvaged, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
PRODUCT Recovered
Plasma.
CODE Unit:06LZ12731
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,
CA,
REASON Blood
product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit:
FN24282
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation,
Sacramento, CA
REASON
Blood product, which may have been exposed to unacceptable storage
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Unit:
06GJ95801
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,
CA,
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
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
3620466
RECALLING FIRM/MANUFACTURER
Northern California Community Blood
Bank, Eureka, CA,
REASON Blood
product, manufactured without the entire quantity of additive solution, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE Unit:
9960479
RECALLING FIRM/MANUFACTURER
Northern California Community Blood
Bank, Eureka, CA,
REASON Blood
product, for which the documented time period out of controlled storage did
not meet specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Recovered
Plasma.
CODE Unit:
06FS06803
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA,
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
PRODUCT
1) Flow PRA Class I Positive Control
Serum.
2) Flow PRA Class II Positive Control
Serum.
CODE
1) Lot Numbers: 8.2 and 9.1;
2) Lot Numbers: 5.1 and 6.1
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA,
REASON Flow
Class I and II Positive Control Serums, with incomplete or positive infectious
disease testing, as required for human source components for use in vitro
diagnostic products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,691 Units
DISTRIBUTION Nationwide
and Internationally
WEEK ENDING JANUARY 7
PRODUCT Cryoprecipitated
AHF.
CODE Units: W067111028696, W067111028688,
W067111022117, W067111023872, W067111022119, W067111028692, W067111028689,
W067111028687, W067111028693, W067111023871
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA,
REASON Blood products, not prepared in
accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
PRODUCT Source Plasma.
CODE Units: 372682804, 0411119080,
0411118068, 0411116780, 0411116240, 0411091655, 0411091073, 0411087479,
0411084365, 0411083573, 0411082504, 0411082108, 0411080944, 0411080569,
0411079707, 0411079125, 0411078313, 0411077989, 0411074630, 0411071192,
0411069998, 0411068291, 0411067425, 0411063477, 0411063056, 0411178134,
0411176648, 0411174723, 374601417, 0411119080, 0411118068, 0411116780,
0411116240, 0411091655, 0411091073, 0411087479, 0411084365, 0411083573,
0411082504, 0411082108, 0411080944, 0411080569, 0411079707, 0411079125,
0411078313, 0411077989, 0411074630, 0411071192, 0411069998, 0411068291,
0411067425, 0411063477, 0411063056
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Oak Park, MI,
REASON Blood products, collected from donors
who were previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION NC and Germany
PRODUCT Cryoprecipitated
AHF, Pooled.
CODE Unit: 4600407
RECALLING FIRM/MANUFACTURER
Northern California Community Blood
Bank, Eureka, CA,
REASON Blood product, not prepared in
accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W043211073244
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN,
REASON Blood product, collected from a donor
for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
PRODUCT
1) Platelets Pheresis Leukocytes Reduced
Irradiated.
2) Platelets Pheresis Leukocytes
Reduced.
CODE
1) Units: W1170115030731 (3 units),
W1170115030811;
2) Units: W1170115030811 (2 units),
W117011503104J (3 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the
Pacific – Irwin Center, San Francisco, CA,
Manufacturer: Blood Centers of the
Pacific – Santa Rosa Center, Santa Rosa, CA. .
REASON Blood products, for which quality
control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
PRODUCT Source Plasma.
CODE Units: 3330191690, 3330191052,
3330190171, 3330189544, 3330188749, 3330188119, 3330187290, 3330186604,
3330185807, 3330183718, 3330180243, 3330185194, 3330184363, 3330182818,
3330182244, 3330179437, 3330178954, 3330180890
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., El
Paso, TX,
REASON Blood products, collected from a donor
who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION NC
PRODUCT Source Plasma.
CODE Units: 3530033072, 3530032514,
3530030209, 3530029269, 3530027418, 3530026146, 3530025644, 3530024361,
3530023809, 3530022566, 3530022098, 3530020743, 3530020183, 3530018633,
3530018067, 3530016676, 3530016108, 3530015093, 3530014475, 3530013342,
3530012792, 3530011715, 3530011123, 3530010121, 3530009584, 3530008514,
3530008010, 3530007068, 3530006534, 3530005197, 3530004751, 3530003758,
3530003354, 3530001791
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma
Resources, Inc., Research Triangle Park, NC,
Manufacturer: Talecris Plasma Resources,
Inc., Flint, MI. .
REASON Blood products, collected from a donor
whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Units: W036511110451; W036511087883
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA,
REASON Blood products, collected from a donor
who reported travel to a leishmania risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
PRODUCT Red Blood Cells
(Apheresis) Leukocytes
Reduced.
CODE Unit: W036811241038
RECALLING FIRM/MANUFACTURER
Community Blood Centers Laboratory
Services, Inc., Lauderhill, FL,
REASON Blood product, labeled with an incorrect
volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
PRODUCT Recovered Plasma.
CODE Unit: W043211073244
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN,
REASON Blood product, collected from a donor
for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
PRODUCT Bone.
CODE Units: 030527779, 030567547, 030566864,
030512563
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services
Division, Nashville, TN,
REASON Bone allografts with positive
post-processing swab cultures were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
PRODUCT Fluzone(R), Influenza Virus Vaccine,
Single-Dose Vials, 0.5 mL, NDC 49281-011-10.
CODE Lot numbers U4114DA, exp 6/30/12;
U4118AA, exp 6/30/12; U4118BA, exp 6/30/12; U4118BB, exp 6/30/12; U4122AA, exp
6/30/12; U4122BA, exp 6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12;
U4124BA, exp 6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp
6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp 6/30/12;
U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp 6/30/12; and U4197AB,
exp 6/30/12
RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA
REASON Fluzone(R), Influenza Virus Vaccine,
Single-Dose Vials, 0.5mL, misbranded due to an error in the Prescribing
Information (PI) included in packages of 10 single-dose vials of Fluzone
vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2,832,810 units
PRODUCT Limulus Amebocyte
Lysate.
CODE Lot A1482L
RECALLING FIRM/MANUFACTURER
Charles River Endosafe, a Division of
Charles River Laboratories, Inc., Charleston, SC,
REASON Limulus Amebocyte
Lysate, possibly
misbranded with missing lot number and expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7,774 units
DISTRIBUTION Nationwide and Internationally