NOVEMBER 2002
WEEK ENDING NOVEMBER 2
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit number KC00846.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood product, collected from an
unsuitable donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit number 06GH67260.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern
California Region, Los Angeles, CA.
REASON Blood product, collected from an
unsuitable donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Counterfeit Procrit_ (Epoetin alfa), labeled as 40000 unit/ml vials, 4
vials/box
CODE Lot numbers P002641 and P002384.
RECALLING FIRM/MANUFACTURER AmeriSourceBergen Corporation, Orange, CA.
REASON Counterfeit drug product, with a concentration of active ingredient less
than labeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 lots.
DISTRIBUTION Nationwide.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Red Blood Cells, Leukocytes Reduced
Irradiated
CODE a) Unit number 0664309; b) Unit number 0664306.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Centers of the Pacific, Irwin
Center, San Francisco, CA.
Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center,
Burlingame, CA.
REASON Blood products, collected from a donor whose hemoglobin test was
incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF.
CODE a) and b) Unit number FJ93945.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode
Island Blood Center, Providence, RI.
REASON Blood products, that tested negative for hepatitis, but were collected
from an ineligible donor due to a subsequent disclosure of previous positive
hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION RI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma.
CODE a) and b) Unit number 04KK60295.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA. Firm initiated recall complete.
REASON Blood products, that tested negative for the antibody to hepatitis C
virus (anti-HCV), but were collected from an ineligible donor based on the
disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VT and CA.
PRODUCT
Fresh Frozen Plasma
CODE Unit LX00037.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood product, collected from a donor on Coumadin therapy, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Units 29GW35656, 29GW35253.
RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Regional Blood
Services, Norfolk, VA.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.
PRODUCT
Fresh Frozen Plasma
CODE Unit numbers 0664309 and 0664306.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Centers of the Pacific, Irwin
Center, San Francisco, CA.
Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center, Burlingame,
CA.
REASON Blood products, collected from a donor whose hemoglobin test was
incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets Pheresis, Leukocytes
Reduced.
CODE a) Unit numbers 012L70114 and 012L70118; b) Unit numbers 012GW22709,
012GW22710, 012GW22711, 012GW22712, 012GW22714 (distributed as two split
units), 012GW22716, 012GW22717, 012GW22718, 012GW22719 (distributed as two
split units), 012GW22720,
012GW22721, and 012GW22722.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC.
REASON Blood products, incorrectly tested for antibodies to hepatitis C virus
(anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION MO, NC and TN.
WEEK
ENDING NOVEMBER 9
PRODUCT Red Blood Cells.
CODE Unit GQ22080.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood product, that was collected from a donor in
which the hemoglobin or hematocrit was not recorded on the donor record, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma.
CODE a) and b) Unit 10733-2286.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ.
REASON Blood products, collected from an ineligible donor,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ and Germany.
PRODUCT Platelet, Pheresis, Leukoreduced.
CODE Unit LZ08659
RECALLING FIRM/MANUFACTURER Recalling Firm: United Blood
Services, Scottsdale, AZ
Manufacturer:
Tri- Counties Blood Bank, Santa Barbara, CA.
REASON Blood product, for which documentation of
irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Tibialis Tendon Allograft.
CODE Model Number T080, Serial Numbers 7840453, 7840496
and 7849215.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Tissues for transplant were collected from a donor
who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AZ and Canada.
PRODUCT Recovered Plasma.
CODE Unit 1848869.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood product, which was manufactured in a manner
that compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) and b) Unit number 10718-4551.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor due to behavior known to
increase risk of infection with human immunodeficiency virus (HIV), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 10730-3467
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Scottsdale, AZ.
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 10733-1892.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Scottsdale, AZ.
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Recovered Plasma.
CODE Unit number 53GV42984.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Chesapeake and Potomac Region, Baltimore, MD
REASON Blood product, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was
collected
from
a donor that subsequently reported a previous reactive test for anti-HIV, was
distributed.
VOLUME OFPRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 10718-6929, 10722-3664, and 10727-9388;
the following units were distributed as two split products: unit numbers 10724-6779, 10725-9726, and
10727-3762.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, collected from an ineligible donor
due to medication with the drug Plavix, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION AZ.
PRODUCT Platelets.
CODE Unit numbers 10733-6925, 10733-6926, 10733-6931, and
10733-6936.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, manufactured from units of Whole
Blood possibly exposed to incorrect shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AZ.
PRODUCT a) Red Blood Cells.
Leukocytes Reduced; b) Fresh Frozen Plasma.
CODE a) and b) Unit number 10705-6239.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, that tested negative for hepatitis,
but were collected from an ineligible donor due to a history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Fresh Frozen
Plasma; c) Cryoprecipitate; d) Plasma.
CODE a) Unit 12V32424; b) Unit 12V32424, 12Y31815,
12X99508; c) Unit 12E25643; d) Unit 12E25643.
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Regional Blood Services,Charlotte, NC
REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma.
CODE a) and b) Unit numbers 27GL24114 and 27S55017.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were
collected from a donor that subsequently reported a previous reactive test for
anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA, WV and OH.
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit number 27GH06764.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood products, that tested negative for hepatitis,
but were collected from an ineligible donor due to a subsequent disclosure of
previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and WV.
PRODUCT Recovered Plasma.
CODE Unit numbers 27FR08996, 48G89326, and 48N30152
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products, that tested negative for hepatitis,
but were collected from an ineligible donor due to a subsequent disclosure of
previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 33GF44411 and 33GF44395.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Connecticut Region, Farmington, CT
REASON Blood products, corresponding to units of Platelets
that were pooled and were possibly contaminated with Streptococcus sp.
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT.
PRODUCT a) Red Blood Cells; b) Platelets Irradiated.
CODE a) and b) Unit number L07618.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells Leukocytes
Reduced; c) Platelets.
CODE a) Unit number S07293; b) Unit number L34688; c)
Unit numbers S07293 and L34688.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA.
PRODUCT a) Red Blood Cells; b) Platelets Irradiated.
CODE a) and b) Unit number L61977.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA.
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT Red Blood Cells.
CODE Unit number C80015.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, collected from an unsuitable donor based
on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Red Blood Cells
CODE Unit number R64420.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Source Plasma.
CODE Unit numbers SC897207, SC904860, SC905211, SC905377,
SC905738, SC905954, SC906759, SC907012, SC907147, SC907361, SC907478, SC907767,
SC908252, SC908442, SC908983, SC909193, 06531379, 06536787, 06384685, 08645685,
08702913, 08706515, 08709080, SC909939, 09143388, and 06543167.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., State College, PA
REASON Blood products, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were
collected from a donor that previously tested repeatedly reactive for anti-HIV,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 26 units.
DISTRIBUTION CA, NY and Germany.
PRODUCT Source Plasma
CODE Unit numbers SH936655, SH937019, SH937311, SH938224,
SH938616, and SH938911
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P.,
Harrisburg, PA
REASON Blood products, that tested negative for antibodies
to hepatitis C virus (anti-HCV), but were collected from a donor that
previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION CA and Germany.
PRODUCT Fresh Frozen Plasma.
CODE Unit 10724-0644.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ.
REASON Blood product, which was incorrectly labeled as
Fresh Frozen Plasma, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Fresh Frozen Plasma.
CODE Unit numbers 27GT73556, 27GT73572, 27LG49833,
27LH02907, 27GJ19910, 27GM65965, 27GS56020, 27GS56025, 27GS56026, 27LJ28578,
27LJ28668, 27LJ28707, 27GC74609, 27GM65868, 27GX49888, 27LH02996, 27GX49890,
27GC74614, 27GC74618, 27GC74629, 27GM65878, 27GM65885, 27LG49933, 27LG49934,
27LH02988, 27LJ28666, 27GM66421, 27GS56419, 27GS55729, 27GS55735, 27LH02852,
27LP00259, 27GC74519, 27GM65694, 27GS55730, 27GY48917, 27GM65967, 27GS56027,
27GY49120, 27GY49125, 27LG49962, 27LJ28647, 27LJ28698, 27GM66501, 27GM65680,
27GT73357, 27GL35050, 27GL35054, 27GL35061, 27GL35077, 27GL35082, 27GT73331,
27GT73376, 27GT73379, 27GT73395, 27GX49656, 27LH02972, 27GC74613, 27GM65890,
27LH02986, 27LM14681, 27GC74671, 27GC74674, 27GM66008, 27LM14526,
27GT73332,
27GX49652, 27GL35546, 27GM66399, 27GM66413, 27GT74232, 27GM66481, 27GM66562,
27GM66573, 27GM66589, 27GM66590, 27GS56472, 27GS56479, 27GT74230, 27GX50306,
27LG50269, 27LM14858, 27GC74533, 27GC74547, 27GM65676, 27GM65790, 27GM65802,
27GT73381, 27GT73384, 27LG49771, 27LG49778, 27LP00255, 27LP00267, 27GJ19850,
27GJ19852, 27GM65826, 27GM65877, 27GS55870, 27LG49876, 27LG49889, 27LG49932,
27N41221, 27N41222, 27N41223, 27N41228, 27N41230, 27N41233, 27N41234,
27N41237, 27GC74603, 27GJ19880, 27GJ19881, 27GJ19883, 27GJ19885,
27GJ19888, 27GJ19895, 27GJ19896, 27GS56006, 27GS56007, 27LC24520, 27LJ28642,
27LJ28643, 27LJ28665, 27LJ28761, 27LM14666, 27GM66388, and 27GX50287.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products, stored at an incorrect temperature,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 127 units.
DISTRIBUTION PA, OH and WV.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 1164519 and 1164840.
RECALLING FIRM/MANUFACTURER Blood Centers of the
Pacific, Irwin Center, San Francisco, CA
REASON Blood products, collected from donors whose arm
inspection were not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit number C80012.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, collected from a donor whose arm
inspection was noted to be unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT a) Red Blood Cells; b) Platelets.
CODE a) and b) Unit number L80246.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from a donor whose arm
inspection was noted to be unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT Platelets.
CODE Unit number L10322.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, manufactured from a unit of Whole
Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Red Blood Cells.
CODE Unit numbers R43377, R43808, and R44384.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, that exceeded the firm's maximum
specification for red blood cell volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.
PRODUCT Platelets, Irradiated.
CODE Unit number M73894.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, collected from an ineligible donor
due to a history of ulcerative colitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Collagenase Santyl? Ointment.
CODE Lot numbers 0000093137, 0000096499, 0000034432,
0000045979, and 34901077.
RECALLING FIRM/MANUFACTURER Advance Biofactures
Corporation, Lynbrook, NY.
REASON Product was found to have decreased potency
throughout the dating period.
VOLUME OF PRODUCT IN COMMERCE 5 lots.
DISTRIBUTION NJ and FL.
WEEK ENDING NOVEMBER 16
PRODUCT
Human Cornea Tissue.
CODE Tissue ID 2000-231C.
RECALLING FIRM/MANUFACTURER Lions Eye Bank for Long Island, North Shore
University Hospital, Manhasset, NY
REASON
Cornea, collected from a donor who tested repeatedly reactive for the antibody
to the Hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION NY.
PRODUCT
a) Hamilton Brand Sunrise Software - for the Microlab AT series Instruments;
b) Hamilton Brand Sunplus Software - for the Microlab AT Plus and AT Plus 2
series Instruments.
CODE a) Versions 1.0, 2.0, 3.0, 4.0, 5.0, 5.1, 5.2, 5.3, 5.3.1, 5.3.3 b)
Versions 1.0, 1.1, 2.0, 3.0, 3.1, 3.2, 3.3, 3.3.1, 3.3.2, 3.3.3.
RECALLING FIRM/MANUFACTURER Recalling Firm: Hamilton Company, Reno, Nevada.
Manufacturer: Hamilton Bonadux AG, Switzerland.
REASON Automated pipette software, which had a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1,158 distributed.
DISTRIBUTION Nationwide.
PRODUCT
Source Plasma.
CODE Units 21075612, 21078422, 26831756, 26835259, 26836867, SH971377.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg, PA.
REASON Blood products, collected from a donor who tested positive for syphilis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION CA and France.
PRODUCT
Source Plasma.
CODE Units 28508885, 28509400, 31873093, 31874281, 31877916, 31878838,
31822343, 31823241, SH997753, 31825924, 31829410, 41750573, 41754030, 41756065,
41758786, SH978455, 41812846, 41815038, 41818305, 41820322, 28363972, SH979025,
28367918, 28800965, 28803140, 28806240, 28808626, 40272184, SH979990, 40274690,
40276441, 40279725, 40281957, 40284767, 41173251, 41175842, 41177846, 41471660,
41482926, SH982141, 41485767, 41489383, 42580584, 42583462, 42584445, 42587675,
SH982141.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg, PA.
REASON Blood products, collected from a donor with a history of having tested
positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 47 units.
DISTRIBUTION CA, NY and France.
PRODUCT
Source Plasma.
CODE Units 12905133, 12907311.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg, PA.
REASON Blood products, collected from a donor who tested positive for syphilis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells.
CODE Unit number 1845886.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood product, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
Red Blood Cells, Leukoreduced.
CODE Units C75537.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, which was labeled as leukoreduced but did not meet the
standard for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Platelets; c) Recovered Plasma.
CODE a); b) and c) Unit 27GM56028.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Greater
Alleghenies Region, Johnstown, PA.
REASON Blood products, collected from a donor who had not completed the
CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA, WV and CA.
PRODUCT Source Plasma.
CODE Unit JM029331
RECALLING FIRM/MANUFACTURER Sera-Tec Biologicals Limited partnership, Jackson,
MS.
REASON Source Plasma, which tested negative for the hepatitis B surface antigen
(HBsAg) but was collected from a donor who subsequently confirmed positive for
HBsAg, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
Platelets Pheresis Leukocyte Removed.
CODE Unit FT000680A.
RECALLING FIRM/MANUFACTURER HemaCare Corporation, Sherman Oaks, CA.
REASON Blood product, which may not have been labeled with the appropriate
volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Platelets Pheresis; b) Fresh Frozen Plasma.
CODE a) Unit number LE4790; b) Unit number LE4790 (distributed as two split
units)
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode
Island Blood Center, Providence, RI.
REASON Blood products, collected from an ineligible donor due to use of the
drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION RI and MA.
PRODUCT
a) Red Blood Cells; b) Platelets.
CODE a) Unit numbers 50H89201, 50FG02226, and 50LJ19440; b) Unit numbers
50H89201 and 50FG02226.
RECALLING FIRM/MANUFACTURER The American National Red Cross,Western Lake Erie
Region, Toledo, OH.
REASON Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH and CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number 6007429.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 01LP45290, 01LM46259, 01LG43775, and 01LG41936;
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross,
New York-Penn Region, West Henrietta, NY Manufacturer: American Red Cross Blood
Services, New York-Penn Region, Buffalo, NY.
REASON Blood products, collected from an ineligible donor due to use of the
medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY and CA.
PRODUCT
Source Plasma.
CODE Unit number MA011160.
RECALLING FIRM/MANUFACTURER Sera-Tec Biologicals Limited Partnership (now
BioLife Plasma Services, L.P.), Mobile, AL.
REASON Blood product, that tested repeatedly reactive for antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION England.
PRODUCT a) Red Blood Cells, Leukocytes Reduced, Irradiated; b) Red Blood Cells,
Leukocytes Reduced; c) Red Blood Cells, Irradiated;
d) Red Blood Cells; e) Platelets; f) Fresh Frozen Plasma; g )Recovered Plasma
CODE a) Units 16-357-0033, 16-357-0080, 16-357-5634, 16-357-0299, 16-358-1922,
16-355-2728, 16-355-3081, 16-355-2717, 16-358-5605, 16-358-5602, 16-358-5571 ,
16-358-5557, 16-358-5503, 16-358-5495, 16-358-5444, 16-358-5435, 16-358-1920,
16-358-1919, 16-358-1918, 16-358-1917, 16-358-1916, 16-358-1915, 16-358-1914,
16-358-5434, 16-358-5431, 16-358-5421, 16-358-5414, 16-358-5407, 16-358-2268,
16-358-2266, 16-358-2264, 16-358-2130, 16-358-2129, 16-358-2126, 16-358-2124,
16-358-1955, 16-358-1953, 16-358-1946 , 16-358-1940, 16-358-1937, 16-358-1934,
16-358-1931, 16-358-1930, 16-358-1929, 16-358-1924, 16-358-1734, 16-358-1733,
16-358-1731, 16-358-1728, 16-358-1727, 16-358-1726, 16-358-1725, 16-358-1724,
16-358-1723, 16-358-1722, 16-358-1720, 16-358-1719, 16-358-1716, 16-358-1716,
16-358-1758, 16-358-1757, 16-358-1756, 16-358-1755, 16-358-1754, 16-358-1751,
16-358-1749, 16-358-1748, 16-358-1747, 16-358-1746, 16-358-1745, 16-358-1744,
16-358-1743, 16-358-1911, 16-358-1910, 16-358-1907, 16-358-1906, 16-358-1905,
16-358-1904, 16-358-1903, 16-358-1901, 16-358-1898, 16-358-1775, 16-358-1774,
16-358-1771, 16-358-1765, 16-358-1761, 16-358-1760, 16-358-1759, 16-357-8060,
16-357-8061, 16-357-8066, 16-357-8067, 16-357-8079, 16-357-8080, 16-357-8082,
16-358-1699, 16-358-1706, 16-358-1707, 16-358-1715, 16-357-8017, 16-357-8019,
16-357-8021, 16-357-8026, 16-357-8027, 16-357-8028, 16-357-8030, 16-357-8031,
16-357-8039, 16-357-8042, 16-357-8043, 16-357-8045, 16-357-8055, 16-357-7843,
16-357-7844, 16-357-7851, 16-357-7861, 16-357-7867, 16-357-7870, 16-357-7875,
16-357-7877, 16-357-7878, 16-357-7882, 16-357-7885, 16-357-8014, 16-357-5794,
16-357-5795, 16-357-5797, 16-357-5798, 16-357-5800, 16-357-5906, 16-357-6140,
16-357-6145, 16-357-6147, 16-357-6151, 16-357-6152, 16-357-7090, 16-357-1029,
16-357-1025, 16-357-1023, 16-357-1020, 16-357-1017, 16-357-1015, 16-357-0995,
16-357-0981, 16-357-0976, 16-357-1202, 16-357-1194, 16-357-1189, 16-357-1188,
16-357-1187, 16-357-1186, 16-357-1185, 16-357-1184, 16-357-1123, 16-357-1112,
16-357-1075, 16-357-1070, 16-357-1068, 16-357-1049, 16-357-1035, 16-357-1033,
16-357-5629, 16-357-5628, 16-357-5616, 16-357-5451, 16-357-4422, 16-357-1279,
16-357-1272, 16-357-1251, 16-357-1247, 16-357-1243, 16-357-1238, 16-357-1233,
16-357-1208, 16-357-1207, 16-357-5793, 16-357-5792, 16-357-5791, 16-357-5790,
16-357-5789, 16-357-5787, 16-357-5786, 16-357-5785, 16-357-5784, 16-357-5705,
16-357-5637, 16-357-5633, 16-357-0732, 16-357-0735, 16-357-0736, 16-357-0738,
16-357-0739, 16-357-0745, 16-357-0747, 16-357-0748, 16-357-0439, 16-357-0335,
06-357-0333, 16-357-0329, 16-357-0328, 16-357-0326, 16-357-0705, 16-357-0706,
16-357-0710, 16-357-0712, 16-357-0717, 16-357-0723, 16-357-0728, 16-357-0790,
16-357-0651, 16-357-0629, 16-357-0622, 16-357-0619, 16-357-0617, 16-357-0616,
16-357-0614, 16-357-0613, 16-357-0467, 16-357-0463, 16-357-0462, 16-357-0440,
16-357-0967, 16-357-0947, 16-357-0943, 16-357-0940, 16-357-0917, 16-357-0913,
16-357-0906, 16-357-0904, 16-357-0902, 16-357-0886, 16-357-0880, 16-357-0798,
16-357-0793, 16-357-0023, 16-357-0039, 16-357-0038, 16-357-0037, 16-357-0036,
16-357-0035, 16-357-0034, 16-357-0030, 16-357-0029, 16-357-0027, 16-357-0025,
16-357-0024, 16-357-0085, 16-357-0084, 16-357-0083, 16-357-0081, 16-357-0076,
16-357-0072, 16-357-0068, 16-357-0067, 16-357-0066, 16-357-0063, 16-357-0062,
16-357-0056, 16-357-0041, 16-357-0190, 16-357-0180, 16-357-0175, 16-357-0166,
16-357-0163, 16-357-0161, 16-357-0158, 16-357-0156, 16-357-0155, 16-357-0152,
16-357-0095, 16-357-0325, 16-357-0304, 16-357-0301, 16-357-0300, 16-357-0298,
16-357-0297, 16-357-0198, 16-357-0195, 16-357-0192, 16-357-0191, 16-356-9586,
16-356-9585, 16-356-9583, 16-356-9582, 16-356-9580, 16-356-9560, 16-356-9546,
16-356-9545, 16-356-9543, 16-356-9542, 16-356-9946, 16-356-9945, 16-356-9943,
16-356-9942, 16-356-9940, 16-356-9939, 16-356-9938, 16-356-9935, 16-356-9933,
16-356-9881, 16-356-9875, 16-356-9589, 16-356-9588, 16-356-9587, 16-357-0008,
16-357-0007, 16-356-9963, 16-356-9960, 16-356-9959, 16-356-9958, 16-356-9957,
16-356-9955, 16-356-9952, 16-365-9951, 16-356-9950, 16-356-9948, 16-356-9947,
16-357-0022, 16-357-0021, 16-357-0020, 16-357-0019, 16-357-0018, 16-357-0017,
16-357-0016, 16-357-0015, 16-357-0014, 16-357-0013, 16-357-0012, 16-357-0010,
16-357-0009, 16-356-9514, 16-356-9511, 16-356-9485, 16-356-9482, 16-356-9481,
16-356-9479, 16-356-9478, 16-356-9476, 16-356-9470, 16-356-9467, 16-356-5711,
16-356-9540, 16-356-9537, 16-356-9536, 16-356-9534, 16-356-9533, 16-356-9532,
16-356-9530, 16-356-9527, 16-356-9523, 16-356-9521, 16-356-9519, 16-356-9516,
16-356-9515, 16-355-4824, 16-355-4823, 16-355-4822, 16-355-4818, 16-355-4847,
16-355-4846, 16-355-4843, 16-355-4840, 16-355-4839, 16-355-4834, 16-355-4833,
16-355-4832, 16-355-4831, 16-355-4827, 16-355-4826, 16-355-4825, 16-355-4862,
16-355-4861, 16-355-4860, 16-355-4858, 16-355-4857, 16-355-4854, 16-355-4853,
16-355-4851, 16-355-4850, 16-355-4849, 16-355-5000, 16-355-4958, 16-355-4957,
16-355-4943, 16-355-4942, 16-355-4871, 16-355-4870, 16-355-4868, 16-355-4867,
16-355-4866, 16-355-4863, 16-355-4688, 16-355-4686, 16-355-4686, 16-355-4685,
16-355-4711, 16-355-4709, 16-355-4707, 16-355-4704, 16-355-4702, 16-355-4700,
16-355-4699, 16-355-4695, 16-355-4694, 16-355-4691, 16-355-4690, 16-355-4689,
16-355-4762, 16-355-4761, 16-355-4759, 16-355-4758, 16-355-4729, 16-355-4728,
16-355-4726, 16-355-4725, 16-355-4721, 16-355-4719, 16-355-4716, 16-355-4776,
16-355-4775, 16-355-4774, 16-355-4773, 16-355-4772, 16-355-4771, 16-355-4770,
16-355-4769, 16-355-4768, 16-355-4766, 16-355-4765, 16-355-4763, 16-355-4816,
16-355-4814, 16-355-4808, 16-355-4807, 16-355-4806, 16-355-4803, 16-355-4802,
16-355-4801, 16-355-4780, 16-355-4777, 16-355-4191, 16-355-4190, 16-355-4189, 16-355-4188,
16-355-4186, 16-355-4185, 16-355-4183, 16-355-4182, 16-355-4354, 16-355-4331,
16-355-4330, 16-355-4200, 16-355-4198, 16-355-4197, 16-355-4195, 16-355-4194,
16-355-4193, 16-355-4192, 16-355-4384, 16-355-4383, 16-355-4380, 16-355-4379,
16-355-4378, 16-355-4374, 16-355-4369, 16-355-4367, 16-355-4355, 16-355-4661,
16-355-4658, 16-355-4656, 16-355-4398, 16-355-4396, 16-355-4394, 16-355-4392,
16-355-4388, 16-355-4387, 16-355-4386, 16-355-4385, 16-355-4684, 16-355-4683,
16-355-4682, 16-355-4681, 16-355-4680, 16-355-4679, 16-355-4677, 16-355-4675,
16-355-4673, 16-355-4670, 16-355-4668, 16-355-4665, 16-355-4664, 16-355-4662,
16-355-3721, 16-355-3719, 16-355-3718, 16-355-3713, 16-355-3708, 16-355-3707,
16-355-3739, 16-355-3738, 16-355-3737, 16-355-3736, 16-355-3735, 16-355-3733,
16-355-3731, 16-355-3730, 16-355-3728, 16-355-3725, 16-355-3724, 16-355-3722,
16-355-3791, 16-355-3787, 16-355-3764, 16-355-3755, 16-355-3753, 16-355-3749,
16-355-3748, 16-355-3747, 16-355-3746, 16-355-3743, 16-355-3742, 16-355-3741, 16-355-3740,
16-355-4087, 16-355-3809, 16-355-3808, 16-355-3807, 16-355-3799, 16-355-3796,
16-355-3795, 16-355-3794, 16-355-3793, 16-355-4120, 16-355-4118, 16-355-4108,
16-355-4106, 16-355-4105, 16-355-4103, 16-355-4102, 16-355-4101, 16-355-4099,
16-355-4097, 16-355-4094, 16-355-4090, 16-355-4088, 16-355-3367, 16-355-3366,
16-355-3364, 16-355-3362, 16-355-3359, 16-355-3354, 16-355-3353, 16-355-3346,
16-355-3344, 16-355-3339, 16-355-3411, 16-355-3409, 16-355-3408, 16-355-3407,
16-355-3406, 16-355-3395, 16-355-3382, 16-355-3381, 16-355-3378, 16-355-3376,
16-335-3370, 16-355-3484, 16-355-3482, 16-355-3481, 16-355-3480, 16-355-3475,
16-355-3444, 16-355-3441, 16-355-3440, 16-355-3438, 16-355-3434, 16-355-3421,
16-355-3419, 16-355-3418, 16-355-3706, 16-355-3590, 16-355-3588, 16-355-3586,
16-355-3540, 16-355-3539, 16-355-3538, 16-355-3537, 16-355-3488, 16-355-3487,
16-355-3180, 16-35-3179, 16-355-3178, 16-355-3177, 16-355-3176, 16-355-3175,
16-355-3098, 16-355-3097, 16-355-3095, 16-355-3094, 16-355-3092, 16-355-3089,
16-355-3088, 16-355-3087, 16-355-3086, 16-355-3085, 16-355-3084, 16-355-3083,
16-355-3198, 16-355-3195, 16-355-3194, 16-355-3191, 16-355-3190, 16-355-3189,
16-355-3188, 16-355-3187, 16-355-3186, 16-355-3185, 16-355-3183, 16-355-3182,
16-355-3181, 16-355-3308, 16-355-3306, 16-355-3305, 16-355-3303, 16-355-3302,
16-355-3301, 16-355-3300, 16-355-3297, 16-355-3296, 16-355-3199, 16-355-3333,
16-355-3332, 16-355-3331, 16-355-3330, 16-355-3325, 16-355-3323, 16-355-3321,
16-355-3318, 16-355-3317, 16-355-3316, 16-355-3315, 16-355-3313, 16-355-3311,
16-355-2942, 16-355-2941, 16-355-2727, 16-355-2974, 16-355-2973, 16-355-2972,
16-355-2969, 16-355-2967, 16-355-2965, 16-355-2960, 16-355-2959, 16-355-2958,
16-355-2955, 16-355-2953, 16-355-2950, 16-355-2947, 16-355-2946, 16-355-3009,
16-355-3008, 16-355-3007, 16-355-3006, 16-355-3005, 16-355-3004, 16-355-3003,
16-355-3001, 16-355-3000, 16-355-2999, 16-355-3082, 16-355-3080, 16-355-3038,
16-355-3033, 16-355-3028, 16-355-3022, 16-355-3021, 16-355-3020, 16-355-3016,
16-355-3015, 16-355-3011, 16-355-3010, 16-355-2724, 16-355-2400, 16-355-2398,
16-355-2335, 16-355-2329, 16-355-2319, 16-355-2318, 16-358-1740, 16-355-3309
b)
Unit 16-358-1912
c)
Units 16-355-3342, 16-355-3337, 16-355-3536, 16-355-3091, 16-355-3319,
16-356-9468, 16-355-3014
d)
Units 16-358-5519, 16-358-5503, 16-358-5496, 16-358-5495, 16-358-5456,
16-358-5444, 16-358-5435, 16-358-5434, 16-358-5431, 16-358-5424, 16-358-1775,
16-358-1771, 16-358-1765, 16-357-8055, 16-357-7861, 16-357-7867, 16-357-7870,
16-357-5794, 16-357-5795, 16-357-5798, 16-357-6140, 16-357-6151, 13-357-6152,
16-357-0981, 16-357-1068, 16-357-5629, 16-357-5616, 16-357-1243, 16-357-1233,
16-357-5792, 16-357-5791, 16-357-5790, 16-357-5786, 16-357-5785, 16-357-5634,
16-357-5633, 16-357-0732, 16-357-0736, 16-357-0738, 16-357-0745, 16-357-0747,
16-357-0748, 16-357-0749, 16-357-0335, 16-357-0333, 16-357-0329, 16-357-0328,
16-357-0326, 16-357-0705, 16-357-0710, 16-357-0712, 16-357-0723, 16-357-0728,
16-357-0967, 16-357-0191, 16-357-0163, 16-357-0161, 16-357-0156, 16-357-0155,
16-357-0152, 16-357-0325, 16-357-0304, 16-357-0301, 16-357-0300, 16-357-0299,
16-357-0298, 16-357-0297, 16-357-0195, 16-357-0192, 16-355-4824, 16-355-4818,
16-355-4847, 16-355-4846, 16-355-4843, 16-355-4862, 16-355-4858, 16-355-4857, 16-355-4853,
16-355-4850, 16-355-4871, 16-355-4870, 16-355-4868, 16-355-4867, 16-355-4866,
16-355-4863, 16-355-4816, 16-355-4808, 16-355-4807, 16-355-4806, 16-355-4803,
16-355-4802, 16-355-4191, 16-355-4354, 16-355-4198, 16-355-4195, 16-355-4192,
16-355-4383, 16-355-4380, 16-355-4379, 16-355-4378, 16-355-4355, 16-355-4388,
16-355-4387, 16-355-4386, 16-355-4385, 16-355-3791, 16-355-3787, 16-355-4087,
16-355-3809, 16-355-3808, 16-355-3807, 16-355-3799, 16-355-3795, 16-355-3411,
16-355-3409, 16-355-3407, 16-355-3406, 16-355-3484, 16-355-3480, 16-355-3539,
16-355-3537, 16-355-3488, 16-355-3487, 16-355-3306, 16-355-3305, 16-355-3303,
16-355-3302, 16-355-3297, 16-355-3330, 16-355-3316, 16-355-3009, 16-355-3008,
16-355-3007, 16-355-3006, 16-355-3000, 16-355-3038, 16-355-3011, 16-355-3010,
16-355-2398
e)
Units 16-357-5800, 16-357-4422, 16-357-5787, 16-357-0736, 16-357-0728,
16-357-1629, 16-357-0622, 16-357-0620, 16-357-0619, 16-357-0617, 16-357-0614,
16-357-0166, 16-357-0161, 16-357-0158, 16-357-0155, 16-357-0304, 16-357-0301,
16-357-0195, 16-355-3791, 16-355-3787, 16-355-3475, 16-355-3539, 16-355-3538,
16-355-3537, 16-355-3487, 16-355-3198, 16-355-3195, 16-355-3309, 16-355-3308,
16-355-3306, 16-355-3305, 16-355-3303, 16-355-3302, 16-355-3300, 16-355-3297,
16-355-3296, 16-355-3199, 16-355-3330, 16-355-3325, 16-355-3321, 16-355-3319,
16-355-3318, 16-355-3317, 16-355-3316, 16-355-3313, 16-355-3311
f) Units 16-358-1734, 16-358-1733, 16-358-1731, 16-358-1728, 16-358-1727,
16-358-1726, 16-358-1725, 16-358-1724, 16-358-1723, 16-358-1722, 16-358-1720,
16-358-1719, 16-358-1775, 16-358-1774, 16-358-1771, 16-357-8080, 16-358-1715,
16-357-8019, 16-357-8026, 16-357-8027, 16-357-8028, 16-357-8030, 16-357-8031,
16-357-8055, 16-357-7861, 16-357-7867, 16-357-7870, 16-357-7885, 16-357-6140,
16-357-6145, 16-357-6147, 16-357-6151, 13-357-6152, 16-357-0981, 16-357-1189,
16-357-1185, 16-357-1075, 16-357-1070, 16-357-1272, 16-357-1208, 16-357-1202,
16-357-5789, 16-357-0735, 16-357-0739, 16-357-0706, 16-357-0790, 16-357-0967,
16-357-0798, 16-357-0793, 16-357-0039, 16-357-0039, 16-357-0038, 16-357-0037,
16-357-0036, 16-357-0035, 16-357-0034, 16-357-0029, 16-357-0152, 16-357-0198,
16-356-9586, 16-356-9585, 16-356-9583, 16-356-9582, 16-356-9580, 16-356-9577,
16-356-9560, 16-356-9946, 16-356-9945, 16-356-9943, 16-356-9942, 16-356-9940,
16-356-9939, 16-356-9938, 16-356-9935, 16-356-9933, 16-356-9589, 16-356-9588,
16-356-9587, 16-356-9963, 16-356-9960, 16-356-9959, 16-356-9958, 16-356-9957,
16-356-9955, 16-356-9952, 16-356-9951, 16-356-9950, 16-356-9948, 16-356-9947,
16-356-9485, 16-356-9479, 16-356-9478, 16-356-9476, 16-356-9470, 16-356-9468,
16-356-9467, 16-355-4824, 16-355-4823, 16-355-4819, 16-355-4818, 16-355-4847,
16-355-4846, 16-355-4843, 16-355-4826, 16-355-4825, 16-355-4862, 16-355-4860,
16-355-4858, 16-355-4857, 16-355-4853, 16-355-4850, 16-355-4871, 16-355-4870,
16-355-4868, 16-355-4867, 16-355-4863, 16-355-4816, 16-355-4815, 16-355-4814,
16-355-4808, 16-355-4807, 16-355-4806, 16-355-4805, 16-355-4803, 16-355-4802,
16-355-4801, 16-355-4191, 16-355-4190, 16-355-4189, 16-355-4188, 16-355-4354,
16-355-4200, 16-355-4199, 16-355-4198, 16-355-4197, 16-355-4195, 16-355-4194,
16-355-4193, 16-355-4192, 16-355-4384, 16-355-4383, 16-355-4380, 16-355-4379,
16-355-4378, 16-355-4374, 16-355-4369, 16-355-4367, 16-355-4355, 16-355-4388,
16-355-4387, 16-355-4386, 16-355-4385, 16-355-4087, 16-355-3809, 16-355-3808,
16-355-3807, 16-355-3800, 16-355-3799, 16-355-3796, 16-355-3795, 16-355-3794,
16-355-3793, 16-355-4118, 16-355-4102, 16-355-4101, 16-355-4097, 16-355-3411,
16-355-3407, 16-355-3406, 16-355-3194, 16-355-3000, 16-355-2999, 16-355-2400,
16-355-2398, 16-355-2329, 16-358-1740, 16-358-1758, 16-358-1757, 16-358-1755,
16-358-1754, 16-358-1751, 16-358-1750, 16-358-1749, 16-358-1748, 16-358-1747,
16-358-1746, 16-358-1745, 16-358-1744, 16-358-1743, 16-358-1761, 16-358-1759,
16-357-8060, 16-357-8061, 16-357-8066, 16-357-8067, 16-357-8079, 16-357-8082,
16-358-1699, 16-358-1706, 16-358-1707, 16-357-8017, 16-357-8021, 16-357-8039,
16-357-8042, 16-357-8043, 16-357-8045, 16-357-7843, 16-357-7844, 16-357-7851,
16-357-7877, 16-357-7878, 16-357-7882, 16-357-8014, 16-357-1033, 16-357-1029,
16-357-1025, 16-357-1023, 16-357-1020, 16-357-1017, 16-357-1015, 16-357-1008,
16-357-0995, 16-357-0976, 16-357-1194, 16-357-1184, 16-357-1123, 16-357-1112,
16-357-1075, 16-357-1049, 16-357-1035, 16-357-1279, 16-357-1251, 16-357-1247,
16-357-1238, 16-357-5705, 16-357-0439, 16-357-0717, 16-357-0651, 16-357-0467,
16-357-0463, 16-357-0462, 16-357-0440, 16-357-0947, 16-357-0943, 16-357-0940,
16-357-0917, 16-357-0913, 16-357-0906, 16-357-0904, 16-357-0886, 16-357-0880,
16-357-0023, 16-357-0033, 16-357-0030, 16-357-0027, 16-357-0025, 16-357-0024,
16-357-0085, 16-357-0084, 16-357-0083, 16-357-0081, 16-357-0080, 16-375-0076,
16-357-0072, 16-357-0068, 16-357-0067, 16-357-0066, 16-357-0063, 16-357-0062,
16-357-0056, 16-357-0180, 16-357-0175, 16-357-0095, 16-357-0293, 16-356-9543,
16-356-9542, 16-356-9881, 16-356-9875, 16-357-0009, 16-357-0008, 16-357-0007,
16-357-0022, 16-357-0021, 16-357-0020, 16-357-0019, 16-357-0018, 16-357-0017,
16-357-0016, 16-357-0015, 16-357-0014, 16-357-0013, 16-357-0012, 16-357-0010,
16-356-9514, 16-356-9482, 16-356-5711, 16-356-9540, 16-356-9537, 16-356-9536,
16-356-9534, 16-356-9533, 16-356-9532, 16-356-9530, 16-356-9527, 16-356-9521,
16-356-9519, 16-356-9516, 16-356-9515, 16-355-4822, 16-355-4821, 16-355-4840,
16-355-4839, 16-355-4834, 16-355-4833, 16-355-4832, 16-355-4831, 16-355-4827,
16-355-4861, 16-355-4854, 16-355-4851, 16-355-4849, 16-355-5000, 16-355-4958,
16-355-4943, 16-355-4942, 16-355-4688, 16-355-4686, 16-355-4685, 16-355-4711,
16-355-4709, 16-355-4707, 16-355-4704, 16-355-4702, 16-355-4700, 16-355-4699,
16-355-4695, 16-355-4694, 16-355-4691, 16-355-4690, 16-355-4689, 16-355-4762,
16-355-4761, 16-355-4759, 16-355-4758, 16-355-4729, 16-355-4728, 16-355-4726,
16-355-4725, 16-355-4721, 16-355-4720, 16-355-4719, 16-355-4716, 16-355-4776,
16-355-4775, 16-355-4774, 16-355-4773, 16-355-4772, 16-355-4771, 16-355-4770,
16-355-4769, 16-355-4768, 16-355-4766, 16-355-4765, 16-355-4763, 16-355-4780,
16-355-4777, 16-355-4186, 16-355-4185, 16-355-4183, 16-355-4182, 16-355-4331,
16-355-4661, 16-355-4658, 16-355-4656, 16-355-4398, 16-355-4396, 16-355-4394,
16-355-4392, 16-355-4684, 16-355-4682, 16-355-4681, 16-355-4680, 16-355-4679,
16-355-4677, 16-355-4675, 16-355-4673, 16-355-4670, 16-355-4668, 16-355-4665,
16-355-4664, 16-355-4662, 16-355-3721, 16-355-3719, 16-355-3718, 16-355-3713,
16-355-3707, 16-355-3739, 16-355-3738, 16-355-3737, 16-355-3736, 16-355-3735,
16-355-3733, 16-355-3731, 16-355-3730, 16-355-3728, 16-355-3725, 16-355-3724,
16-355-3722, 16-355-3764, 16-355-3755, 16-355-3753, 16-355-3749, 16-355-3747,
16-355-3746, 16-355-3743, 16-355-3742, 16-355-3741, 16-355-3740, 16-355-4120,
16-355-4108, 16-355-4106, 16-355-4105, 16-355-4104, 16-355-4103, 16-355-4094,
16-355-4090, 16-355-4088, 16-355-3367, 16-355-3366, 16-355-3364, 16-355-3362,
16-355-3359, 16-355-3354, 16-355-3353, 16-355-3346, 16-355-3344, 16-355-3342,
16-355-3339, 16-355-3337, 16-355-3336, 16-355-3408, 16-355-3395, 16-355-3382,
16-355-3381, 16-355-3378, 16-355-3376, 16-355-3370, 16-355-3481, 16-355-3444,
16-355-3441, 16-355-3440, 16-355-3438, 16-355-3434, 16-355-3421, 16-355-3419,
16-355-3418, 16-355-3706, 16-355-3590, 16-355-3588, 16-355-3586, 16-355-3540,
16-355-3535, 16-355-3180, 16-355-3179, 16-355-3178, 16-355-3177, 16-355-3176,
16-355-3175, 16-355-3098, 16-355-3094, 16-355-3087, 16-355-3086, 16-355-3085,
16-355-3084, 16-355-3191, 16-355-3190, 16-355-3189, 16-355-3188, 16-355-3187,
16-355-3186, 16-355-3185, 16-355-3183, 16-355-3182, 16-355-3181, 16-355-3333,
16-355-3332, 16-355-3331, 16-355-2942, 16-355-2941, 16-355-2728, 16-355-2727,
16-355-2725, 16-355-2974, 16-355-2973, 16-355-2972, 16-355-2969, 16-355-2965,
16-355-2960, 16-355-2959, 16-355-2958, 16-355-2955, 16-355-2953, 16-355-2950,
16-355-2947, 16-355-2946, 16-355-3009, 16-355-3008, 16-355-3007, 16-355-3006,
16-355-3005, 16-355-3004, 16-355-3003, 16-355-3001, 16-355-3080, 16-355-3038,
16-355-3033, 16-355-3028, 16-355-3022, 16-355-3021, 16-355-3020, 16-355-3016, 16-355-3015,
16-355-3011, 16-355-3010, 16-355-2724, 16-355-2717, 16-355-2335, 16-355-2319,
16-355-4330, 16-355-3409, 16-358-1765, 16-357-7875, 16-355-4866.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: United Blood Services, Meridian, MS.
REASON Blood products, collected in a manner that compromises the sterility of
the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 2 units; b) 693 units; c) 1 unit; d) 7 units;
e) 139 units; f) 46 units; g) 533 units;
DISTRIBUTION AL, MS, MO, LA, NY, VA and Switzerland.
PRODUCT
Abbott HCV EIA 2.0 Diagnostic Kit, Hepatitis C Virus Encoded Antigen
(Recombinant c100-3, HC-31, HC-34)
CODE Lot 91988M101.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL.
REASON HCV test kits, containing a conjugate concentrate that has the potential
to be overfilled, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,339 test kits.
DISTRIBUTION Nationwide.
PRODUCT Collagenase, Santyl Ointment.
CODE Lot number 0000075211, expiration date 2/05
RECALLING FIRM/MANUFACTURER Advance Biofactures Corporation, a subsidiary of
Biospecifics Technologies Corporation, Lynbrook
REASON
Drug product, which exceed potency specifications (super-potent), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 13,692 units.
DISTRIBUTION Nationwide.
PRODUCT
Source Plasma.
CODE BRXGNW, BRXGNX, BRXGNY, BRXGNZ, BRXGPB, BRXGPC, BRXGPD, BRXGPF, BRXGPG,
BRXGPH, BRXGPJ, BRXGPK, BRXGPL, BRXHBF, BRXGPM, BRXGPN, BRXGPP, BRXGPQ, BRXGPR,
BRXHBB, BRXGPS, BRXGPT, BRXGPV, BRXGPW, BRXGPX, BRXGPY, BRXGPZ, BRXGQB, BRXGQC,
BRXGQD, BRXGQF, BRXGQG, BRXGQH, BRXGQJ, BRXGQK, BRXHBL, BRXGQL, BRXGQM, BRXGRD,
BRXHBC, BRXGRF, BRXGRG, BRXGRJ, BRXGRK, BRXGRL, BRXGRM, BRXGRN, BRXGRP, BRXGRQ,
BRXGRR, BRXGRS, BRXGRT, BRXGRV, BRXGRW, BRXGRY, BRXGRZ, BRXGSB, BRXGSC, BRXGSD,
BRXGSF, BRXGSG, BRXGSH, BRXGSJ, BRXGSK, BRXGSL, BRXGSM, BRXGSN, BRXGSP, BRXGSQ,
BRXGSR, BRXGSS, BRXGST, BRXGSV, BRXGSW, BRXGSX, BRXGSY, BRXGSZ, BRXHBY, BRXGTB,
BRXGTC, BRXGTD, BRXGTF, BRXGTG, BRXGTH, BRXGTJ, BRXGTK, BRXGTL, BRXGTM, BRXGTN,
BRXGTP, BRXGTQ, BRXGTR, BRXGTS, BRXGTT, BRXHCJ, BRXGTV, BRXGTW, BRXGTX, BRXGTY,
BRXGTZ, BRXHCH, BRXGVB, BRXGVC, BRXGVD, BRXGVF, BRXGVG, BRXGVH, BRXGVJ, BRXGVK,
BRXGVL, BRXGVM, BRXGVN, BRXGVP, BRXGVQ, BRXGVR, BRXGVS, BRXGVT, BRXGVV, BRXGVW,
BRXGVX, BRXGVY, BRXGVZ, BRXGWB, BRXGWC, BRXGWD, BRXGWF, BRXGWG, BRXGWH, BRXGWJ,
BRXGWK, BRXGWL, BRXGWM, BRXGWN, BRXGWP, BRXGWQ, BRXGWS, BRXGWT, BRXGWV, BRXGWW,
BRXGWX, BRXGWY, BRXGWZ, BRXGXB, BRXGXC, BRXGXD, BRXGXF, BRXGXG, BRXGXH, BRXGXJ,
BRXGXK, BRXGXL, BRXGXM, BRXGXN, BRXGXP, BRXGXQ, BRXGXR, BRXGXS, BRXGXT, BRXGXV,
BRXGXW, BRXGXX, BRXGYN, BRXGYP, BRXGYQ, BRXGYR, BRXGYS, BRXGYT, BRXGYV, BRXGYW,
BRXGYX, BRXGYY, BRXGYZ, BRXGZB, BRXGZR, BRXGZS, BRXGZT, BRXGZV, BRXGZW, BRXGZX,
BRXGZY, BRXGZZ, BRXHBD, BRXHBG, BRXHBH, BRXHBJ, BRXHBK, BRXHBM, BRXHBN, BRXHBP,
BRXHBQ, BRXHBR, BRXHBS, BRXHBT, BRXHBV, BRXHBW, BRXHBX, BRXHBZ, BRXHCB, BRXHCC,
BRXHCD, BRXHCF, BRXHCG, BRWRNV, BRWRNW, BRWRNX, BRWRNY, BRWRNZ, BRWRPB, BRWRPC,
BRWRXJ, BRWRPD, BRWRPF, BRWRPG, BRWRPH, BRWRXM, BRWRPJ, BRWRQP, BRWRQQ, BRWRQR,
BRWRQS, BRWRQT, BRWRQV, BRWRQW, BRWRQX, BRWRQY, BRWRQZ, BRWRRB, BRWRRC, BRWRRS,
BRWRRT, BRWRRV, BRWRRW, BRWRRX, BRWRRY, BRWRRZ, BRWRSB, BRWRSC, BRWRSD, BRWRSF,
BRWRSG, BRWRSH, BRWRSJ, BRWRSK, BRWRSL, BRWRSM, BRWRSN, BRWRSP, BRWRSQ, BRWRSR,
BRWRSS, BRWRST, BRWRSV, BRWRSW, BRWRSX, BRWRSY, BRWRSZ, BRWRTB, BRWRTC, BRWRTD,
BRWRTF, BRWRTG, BRWRTH, BRWRTJ, BRWRTK, BRWRTL, BRWRTM, BRWRTN, BRWRTP, BRWRTQ,
BRWRTR, BRWRTS, BRWRTT, BRWRTV, BRWRTW, BRWRTX, BRWRTY, BRWRTZ, BRWRVB, BRWRVC,
BRWRVD, BRWRVF, BRWRVG, BRWRVH, BRWRVJ, BRWRVK, BRWRVL, BRWRVM, BRWRVN, BRWRVP,
BRWRVQ, BRWRVR, BRWRVS, BRWRVT, BRWRVV, BRWRVW, BRWRVX, BRWRVY, BRWRVZ, BRWRWB,
BRWRWC, BRWRWD, BRWRWF, BRWRWG, BRWRWH, BRWRWJ, BRWRWK, BRWRWL, BRWRWM, BRWRWN,
BRWRWP, BRWRWQ, BRWRWR, BRWRXH, BRWRXK, BRWRXL, BRWRXN, BRWRXP, BRWRXQ, BRWRXR,
BRWRXS, BRWRXT, BRWRXV, BRWRXW, BRWRXX, BRWRXY, BRWRXZ, BRWRYB, BRWRYC, BRWRYD,
BRWRYF, BRWRYG, BRWRYH, BRWRYJ, BRWRYK, BRTXLM, BRTXPH, BRTXLN, BRTXLP, BRTXLQ,
BRTXLR, BRTXLS, BRTXLT, BRTXLV, BRTXLW, BRTXLX, BRTXLY, BRTXLZ, BRTXMB, BRTXMC,
BRTXMD, BRTXMF, BRTXMG, BRTXMH, BRTXMJ, BRTXMK, BRTXML, BRTXMM, BRTXMN, BRTXMP,
BRTXMQ, BRTXMR, BRTXMS, BRTXMT, BRTXMV, BRTXMW, BRTXMX, BRTXMY, BRTXMZ, BRTXNB,
BRTXNC, BRTXND, BRTXNF, BRTXNG, BRTXNH, BRTXNJ, BRTXNK, BRTXNL, BRTXNM, BRTXNN,
BRTXNP, BRTXNQ, BRTXNR, BRTXNS, BRTXNT, BRTXNV, BRTXNW, BRTXNX, BRTXNY, BRTXNZ,
BRTXPB, BRTXPC, BRTXPD, BRTXPF, BRTXPG, BRTXPJ, BRTXPK, BRTXPL, BRTXPM, BRTXPN,
BRTXPP, BRTXPQ, BRTXPR, BRTXPS, BRTXPT, BRTXPV, BRTXPW, BRTRFT, BRTRGQ, BRTRFV,
BRTRGH, BRTRFW, BRTRFX, BRTRFY, BRTRGS, BRTRFZ, BRTRGB, BRTRGV, BRTRGC, BRTRGD,
BRTRGF, BRTRGG, BRTRGJ, BRTRGK, BRTRGL, BRTRGM, BRTRGN, BRTRGP, BRTRGR, BRTRGT,
BRTRGW, BRSMNK, BRSMNL, BRSMNM, BRSMNN, BRSMNP, BRSMNQ, BRSMNR, BRSMNS, BRSMNT,
BRSMNV, BRSMNW, BRSMNX, BRSMNY, BRSMPB, BRSMPC, BRSMPD, BRSMPF, BRSMPG, BRSMPH,
BRSMPJ, BRSMPK, BRSMPL, BRSMPM, BRRNSQ, BRRNSR, BRRNSS, BRRNST, BRRNSV, BRRNSW,
BRRNSX, BRRNSY, BRRNSZ, BRRNTB, BRRNTC, BRRNTD, BRRNTT, BRRNTV, BRRNTW, BRRNTX,
BRRNTY, BRRNTZ, BRRNVB, BRRNVC, BRRNVD, BRRNVF, BRRNVG, BRRNVH, BRPRZN, BRPRZP,
BRPRZY, BRPRZQ, BRPRZR, BRPRZS, BRPRZT, BRPRZV, BRPRZW, BRPRZX, BRPRZZ, BRPSBB,
BRXGXY, BRXGXZ, BRXGYB, BRXGYC, BRXGYD, BRXGYF, BRXGYG, BRXGYH, BRXGYJ, BRXGYK,
BRXGYL, BRXGYM.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc.,
Knoxville, TN.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH.
REASON Source Plasma, that was exposed
to unacceptable storage temperatures and was not properly relabeled as Source
Plasma, Salvaged, was distributed.
VOLUME OF PRODUCT IN COMMERCE 501 units.
DISTRIBUTION IN, Germany and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 42K51813 and 42K51767.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio
Region, Cleveland, OH
REASON
Blood products, that tested out of specification for hematocrit, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 1763108 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Blood products, labeled with the incorrect expiration date, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.
PRODUCT
Recovered Plasma.
CODE Unit numbers 01LP45290, 01LM46259, 01LG43775, and 01LG41936.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross,
New York-Penn Region, West Henrietta, NY
Manufacturer:
American Red Cross Blood Services, New York-Penn Region, Buffalo, NY.
REASON Blood products, collected from an ineligible donor due to use of the
medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY and CA.
WEEK ENDING NOVEMBER 23
PRODUCT Source Plasma.
CODE Unit number
HV015463.
RECALLING FIRM/MANUFACTURER Sera-Tec
Biologicals Limited Partnership (now BioLife Plasma Services, L.P.),
Huntsville, AL
REASON Blood products, that tested negative for viral
markers, but were collected from a donor that subsequently admitted to multiple
risk factors for increased incidence of infection with human immunodeficiency
virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit numbers
HV006189, HV006900, and HV007003.
RECALLING FIRM/MANUFACTURER Sera-Tec
Biologicals Limited Partnership (now BioLife Plasma Services, L.P.),
Huntsville, AL.
REASON Blood products,
collected from an unsuitable donor due to a history of residing in the United
Kingdom for more than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units.
DISTRIBUTION NC.
PRODUCT Human Tissue for Transplantation, Skin Tissue.
CODE Tissue number
WS030902.
RECALLING FIRM/MANUFACTURER New
York Firefighters Skin Bank at New York, Presbyterian Hospital, New York, NY.
REASON Human tissue
for transplantation that tested repeatedly reactive for antibodies to hepatitis
C virus (anti-HCV) was distributed.
VOLUME OF PRODUCT IN COMMERCE 15
tissues.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Fresh Frozen Plasma; d) Recovered Plasma.
CODE a) Unit number
39E26569; b) Unit numbers 27LX04404 and 27LV00370; c) Unit number 39E26569; d)
Unit number 27LX04404 and 27LV00370.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood products,
that tested negative for hepatitis, but were collected from an ineligible donor
due to a subsequent disclosure of previous positive hepatitis testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units.
DISTRIBUTION KY, NY
and WV.
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma.
CODE a) Unit numbers
27LY00662 and 39K01452; b) Unit numbers 27LY00662 and 39K01452; c) Unit number
27LY00662 and 39K01452.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood products,
that tested negative for hepatitis and human immunodeficiency virus (HIV), but
were collected from an ineligible donor due to a subsequent disclosure of
previous positive hepatitis and HIV testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units.
DISTRIBUTION NY and
WV.
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE a) Unit numbers
39J90887, 39J77026, and 39J39964; b) Unit numbers 39J90887, 39J77026, and
39J39964.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products,
that tested negative for hepatitis, but were collected from an ineligible donor
due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units.
DISTRIBUTION WV and
CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number
26170-0593.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Fort Smith, AR.
REASON Blood product,
that tested negative for Cytomegalovirus (CMV), but was collected from a donor
who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AR.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets.
CODE a) Unit number
26167-6600; b) Unit number 26167-6600.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Fort Smith, AR.
REASON Blood products,
collected from an unsuitable donor based on travel to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION AR.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number
26166-9437.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Fort Smith, AR.
REASON Blood product,
collected from an unsuitable donor based on travel to an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AR.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) Unit number
26169-8802; b) Unit number 26169-8802.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Fort Smith, AR.
REASON Blood products,
collected from an ineligible donor based on the reported use of medications,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION AR.
PRODUCT Red Blood Cells.
CODE Unit 311276629.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
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 MS.
PRODUCT Red Blood Cells.
CODE Unit 311281421.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
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 MS.
PRODUCT Platelets Pheresis Leukocytes Removed
CODE Unit 311294359.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
REASON Blood product,
which was collected in a manner that may have compromised the sterility of the
collection system, was distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION MS.
PRODUCT Fresh Frozen Plasma.
CODE Unit 311278228.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
REASON Blood product,
which was collected in a manner that may have compromised the sterility of the
collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AL.
PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 311298643.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
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 MS.
PRODUCT Red Blood Cells.
CODE Unit 163537950.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Jackson, MS.
REASON Blood product,
which was collected from a donor who had no hemoglobin check performed during
screening, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION MS.
PRODUCT a) Red Blood Cells Leukocytes Removed; b) Recovered
Plasma.
CODE a) Unit
163610679; b) Unit 163610679.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Jackson, MS.
REASON Blood products,
which were not tested for syphilis as required by the manufacturer's test kit
instructions, were distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION MS and
VA.
PRODUCT Source Plasma.
CODE Unit numbers
GM096924, GM096800, GM096612, GM096489, GM096123, GM095947, GM095709, and
GM095614.
RECALLING FIRM/MANUFACTURER Sera-Tec
Biologicals Limited Partnership (now BioLife Plasma Services, L.P.),
Greenville, MS.
REASON Blood products,
collected from an ineligible donor based on previous elevated testing for
alanine aminotransferase (ALT), were distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers
27LE36463, 27LE36465, 27GM54347, 27LM09975, and 27GY40032.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products,
that tested out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers
27FS16762, 27GT61728, 27GT61738, 27FN90555, 27GC70017, 27GC70021, 27GC70022,
27GC70035, 27GC70084, 27GY40196, 27GY40220, 27GY40241, 27GY40245, 27LF39006,
27S53059, 27LM10124, 27LJ20931, 27LJ20933, 27S53013, 27LG40588, 27LJ20926,
27GL24785, 27GS46972, 27GL25521, 27LF38856, 27LF38902, 27GL24805, 27H40815,
27LC16808, 27LG40626, 27FN90584, 27GG15082, 27GY40212, 27LC16826, 27LJ20942,
27GL24819, 27GS46979, 27GG15084, 27GL24833, 27LE36616, 27LM10044, 27GS46817,
27GS46854, 27GS46788, 27GS46849, 27GS46851, 27GS46959, 27LM10089, 27GL24818,
27GS46910, 27GS46927, 27GS46934, and 27LM10064.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products
exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 53
units.
DISTRIBUTION PA, OH
and WV.
PRODUCT a) Red Blood Cells, Leukocytes Reduced Irradiated;
b) Platelets Pheresis, Leukocytes Reduced.
CODE a) Unit number
26169-5142; b) Unit numbers 26169-5139 (distributed as two split units) and
26169-5141.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Fort Smith, AR.
REASON Blood products,
aliquoted using tubing from expired component bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units.
DISTRIBUTION AR.
PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 311298691.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
REASON Blood product,
which was incorrectly labeled with an extended expiration date, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION MS.
PRODUCT Red Blood Cells Pheresis Leukocytes Removed.
CODE Unit 311302561.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Tupelo, MS.
REASON Blood product,
which was collected in a manner that may have compromised the sterility of the
collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION MS.
PRODUCT