FEBRUARY 2002
WEEK ENDING FEBRUARY 2
PRODUCT Source Plasma
CODE Units:
G-48394-056, G-48025-056, G-38638-056, G-37978-056, G-35883-056,
G-35780-056, G-34200-056, G-33772-056, G-29890-056, G-29440-056, G-26378-056, G-25993-056,
G-93361-056, G-93132-056, G-49156-056, G-48765-056, G-13125-056, G-12399-056,
G-12130-056, G-11479-056, G-11263-056, G-10600-056, G-10357-056, G-84454-056,
G-18297-056, G-18082-056, G-14859-056, G-14623-056, G-08786-056.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles, CA
Manufacturer:
Alpha Therapeutic Corporation, Fontana, CA.
REASON Blood products, which tested negative for Hepatitis
B Surface Antigen (HBsAg), but were collected from a donor who previously
tested reactive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION CA, VA, Spain, Germany and Italy.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Removed
CODE a) Unit
21KK35266; b) Unit 21GW30233.
RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Platelets, pooled
CODE a) Unit E136841; b) Unit E136841; pool number EP01429.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and
Program, Seattle, WA
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA.
PRODUCT a) Red Blood Cells; b) Platelets, pooled
CODE a) Unit
N115528; b) Unit N115528; pool
number AP16227.
RECALLING FIRM/MANUFACTURER Recalling Firm: Puget Sound Blood Center and Program,
Seattle, WA
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) Units
8508783, 1135702; b) Unit
1135702.
RECALLING FIRM/MANUFACTURER Community Blood Center
(CBC), Dayton, OH
REASON Blood products, not tested for CMV antibodies and labeled
CMV negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH and IN.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a), b) and c) Unit 2218610.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
REASON Blood products, collected from a donor who took the
drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.
PRODUCT Red Blood Cells
CODE Unit 21FM63277.
RECALLING FIRM/MANUFACTURER American Red Cross,
Portland, OR,
REASON Blood product, collected from a donor who reported
having lived in area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WA.
PRODUCT Platelet
CODE Unit 1824390.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Platelets, which were prepared from a unit collected
from a donor who had taken aspirin within three days of donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Recovered Plasma
CODE Units Y60440, Y60441.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA,
REASON Blood products, not tested for viral markers, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma
CODE a), b) and c) Unit G33027;
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Center, Grand Rapids, MI
REASON Blood products, collected from an ineligible donor
due to risk of infection with Group O type human immunodeficiency virus (HIV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI and Switzerland.
PRODUCT Red Blood Cells
CODE Unit number 22416-8110.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Las Vegas, NV.
REASON Blood product, collected from an unsuitable donor
based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.
PRODUCT a) Platelets Pheresis; b) Leukocytes Reduced
CODE a) Unit 22418-6595-01; b) Unit 22418-6595-02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc. Las Vegas, NV.
REASON Platelets with an elevated platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NV.
PRODUCT Source Plasma
CODE Unit numbers 0140756148, 0040623808, 0040823805, 0120211580,
0590141808, 0110681976, and 8010090164.
RECALLING FIRM/MANUFACTURER Nabi, Miami, FL
REASON Blood products, that tested initially reactive for
either hepatitis B surface antigen (HBsAg), the antibody to hepatitis C virus
(anti-HCV), or the antibodies to human immunodeficiency virus, types 1 and 2
(anti-HIV-1/2), and were not correctly retested in duplicate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION NC, NY, TN, CA and Germany.
PRODUCT Red Blood Cells
CODE Unit 21KL32346.
RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.
PRODUCT Red Blood Cells
CODE Unit 42N15248.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood product, not quarantined after receiving
information concerning post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Platelets
CODE Unit 1845706.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Platelets, prepared from a donor that had ingested
aspirin within 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Platelets
CODE Unit 1835970.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Platelets, prepared from a donor that had ingested aspirin
within 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit
42Q71434.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Cleveland, OH
REASON Blood product, that failed red cell recovery ratio,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Platelets Pheresis
CODE Unit P05047.
RECALLING FIRM/MANUFACTURER Northern California
Community Blood Bank, Eureka, CA
REASON Blood product, collected from an ineligible donor
who recently had surgery for an arm wound, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Platelets; c)
Cryoprecipitated AHF, Pooled
CODE a), b) and c) Unit 0525732.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Blood products, collected from ineligible donor due
to a history of Herpes Simplex, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.
PRODUCT Fresh Frozen Plasma
CODE Unit numbers 3927197, 3927203, 3927207, 3927169,
3927170, 3927172, 3927176, 3927099, 3927101, 3927108, 3927111, 3927118,
3927119, 3927120, 3948748, 3968478, 3976993, 3976994, 3948757, 3948758,
3948762, 3948766, 3948771, 3948773, 3948775, 3948779, 3948780, 3968487,
3976996, 3948784, 3948785, 3948788, 3948795, 3948797, 4017448, 3927137,
3927138, 3927140, 3927143, 3927145, 3927146, 3927147, 3927150, 3927151,
3937167, 3937169, 3937173, 3964855, 3815795, 3815796, 3815797, 3815800,
3815806, 3723396, 4022611, 4022612, 3941973, 3941959, 3965109, 3965110,
3965115, 3965119, 3965124, 3965126, 3965130, 3982222, 3982224, 3982228,
3981957, 3982234, 3965141, 3981972, 3927057, 3964854, 3964856, 3815807,
3815823, 3723395, 3723399, 3723401, 3723402, 3723441, 3723444, 3723445,
3723450, 3723452, 4022597, 4022613, 4022634, 3965107, 3965116, 3965117,
3965122, 3965135, 3982213, 3982215, 3982218, 3982225, 3982233, 3981951,
3981952, 3981956, 3981958, 3981959, 3981961, 3981962, 3981964, 3981966,
3981967, 3981968, 3981969, 3981971, 3981973, 3981974, 3981975, 3982235,
3927182, 3815810, 3941975, 3965108, 3965112, 3965118, 3965128, 3982211,
3981953, 3927082, 3927059, 3979209, 3964864, 3965111, 3965113, 3927124,
3927130, 3927131, 3927132, 3964851, 3964863, 3815828, 3815829, 3815843,
3815845, 3815854, 3941977, 3941956, 3941960, 3941990, 3941984, 3941983,
3941981, 3965123, 3965129, 3965132, 3965133, 3965134, 3965137, 3965140,
3965142, 3965143, 3965144, 3965145, 3965150, 3982212, 3982216, 3982220,
3982223, 3982230, 3982231, 3982232, 3981954, 3981955, 3981963, 3981965,
3981970, 3981977, 3979250, 3979212, 3979224, 3927194, 3927078, 3979245,
3965114, 3965125, 3965127, and 3965139
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center,Houston, TX
REASON Blood products, collected with expired needles, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 184 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 22420-3101 and 22420-6698.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Las Vegas, NV.
REASON Blood products that were out of controlled storage
for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NV.
PRODUCT Hemocare Blood Bank Data Management System Software,
CODE Versions
5.1, 5.2, 5.2a, and 5.2b.
RECALLING FIRM/MANUFACTURER Mediware Information
Systems, Inc., Melville, NY
REASON Computer software that could allow the assignment of
an extended expiration date to blood products was distributed.
VOLUME OF PRODUCT IN COMMERCE 4 versions.
DISTRIBUTION Nationwide and Canada.
WEEK ENDING FEBRUARY 9
PRODUCT Red Blood Cells
CODE Unit 2911333425.
RECALLING FIRM/MANUFACTURER Lancaster Regional Medical
Center, Lancaster, PA
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Pheresis
CODE Unit 3874929.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
REASON Blood products, collected from a donor taking
Profasi, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Units 1795701, 1755876.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks
Inc., West Palm Beach, FL
REASON Blood products, which tested negative for the
antibody to the human T-lymphotropic virus type I/II (anti-HTLV-I/II), but were
collected from a donor who on two occasions previously tested repeatedly
reactive for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION FL.
PRODUCT Red Blood Cells
CODE Unit 24KZ27851.
RECALLING FIRM/MANUFACTURER American National Red Cross
Blood Services, River Valley Region, Louisville, KY
REASON Blood product, collected from a donor who reported
having lived in an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit LN47506.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which tested initially reactive for
anti-HBcore, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Fresh Frozen Plasma
CODE a); b) and c) Unit T70265.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern
Wisconsin Inc., Milwaukee, WI
REASON Blood products, collected from a donor who provided
post-donation information related to having tested positive for hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit 32FE81402.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services,
Badger-Hawkeye Region, Madison, WI
Manufacturer: Badger-Hawkeye Region-Waterloo Facility,
Waterloo, IA.
REASON Blood product, collected in a manner that may have
compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Platelets
CODE Units
32GR13615, 32GR13616, 32GR13617, 32GR13618, 32GR13619, 32GR13620.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services,
Badger-Hawkeye Region, Madison, WI
Manufacturer: Badger-Hawkeye Region-Green Bay Facility,
Green Bay, WI.
REASON Platelets, with decreased platelet counts, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Units R13249, KM34373, LH59355.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin Inc., Milwaukee, WI
REASON Blood products, which had a low platelet count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit FW09803.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern
Wisconsin Inc., Milwaukee, WI
REASON Blood product, collected from a donor with a history
of engaging in high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit 16L40248; b) Unit 16L40248.
RECALLING FIRM/MANUFACTURER American Red Cross, Central
Ohio Region, Columbus, OH
REASON Blood products, collected from a donor who provided
post donation information related to a positive test for hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Allergenic Extract Special Preparation, 15 ML
CODE Lot 17099003
RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio
Inc., Columbus, OH
REASON Allergenic extract was labeled with an extended
expiration date.
VOLUME OF PRODUCT IN COMMERCE 1 vial.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Recovered Plasma for Further
Manufacture of Injectables.
CODE a) and b) Unit 29FN34981.
RECALLING FIRM/MANUFACTURER American Red Cross,
Mid-Atlantic Regional Blood Services, Norfolk, VA
REASON Blood products, collected from a donor with von
Willebrand's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA and CA.
PRODUCT Fresh Frozen Plasma
CODE Unit number 084GS17440.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region, Oakland, CA
REASON Blood product, manufactured from a unit of Whole
Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Fresh Frozen Plasma
CODE Unit number 084Q52217.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region, Oakland, CA
REASON Blood product, manufactured from a unit of Whole Blood
with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Fresh Frozen Plasma
CODE Unit number 084GS16012.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region, Oakland, CA
REASON Blood product, manufactured from a unit of Whole
Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Fresh Frozen Plasma; b) Cryoprecipitated AHF
CODE a) and b) Unit number 084Q51444.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region, Oakland, CA
REASON Blood products, manufactured from a unit of Whole
Blood with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE (Split units-2), Units 24210-0071.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Rapid City, SD.
REASON Blood products, collected under conditions where the
sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA.
WEEK ENDING FEBRUARY 16
PRODUCT Red Blood Cells
CODE Unit GK48567.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced Units
CODE 21KC25927, 21KC25975, 21KC25984, 21KC25993,
21KC25911, 21KC26059, 21KC25904, 21KC25910, 21KC25979, 21KC25981, 21KC26068,
21KC26071, 21KC26000, 21KC26002, 21KC26003, 21KJ59739, 21KJ59743, 21KJ59749,
21KJ59750, 21KJ59751, 21KC26049, 21KC26064, 21KC26045, 21KC26069, 21KJ59717,
21KJ59718, 21KJ59721, 21KJ59732, 21KJ59736, 21KJ59747, 21KC26065, 21KC26073,
21FM71818, 21FM71823, 21FM71829, 21FM71855, 21FT36620, 21GY73884, 21KC25885,
21KC25890, 21KC25892, 21KJ59715, 21KJ59716, 21KJ59728, 21KJ59729, 21KW07539,
21KZ03873, 21KJ59663, 21KM28345, 21KC25943, 21KC25974, 21FM71825, 21FM71837,
21FM71851, 21FZ06573, 21GW33220, 21FM71777, 21GL65904, 21GY73846, 21GY73853,
21GY73879, 21KH59551, 21KL39407, 21Y67612, 21KC25833,
21KC25849,
21KJ59696, 21KR18255, 21KW07524, 21KW07526, 21KW07535, 21KW07538, 21KZ03859,
21KZ03864, 21KZ03866, 21KZ03874, 21KZ03876, 21KZ03877, 21KZ03882
RECALLING FIRM/MANUFACTURER American Red Cross,
Portland, OR
REASON Blood products, stored at incorrect temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 79 units.
DISTRIBUTION WA and OR.
PRODUCT Safetrace, TX
CODE Versions 1.2.1, 2.0.0, 2.1.0, information systems.
RECALLING FIRM/MANUFACTURER Global Med Technologies,
Inc., El Dorado Hills, CA
REASON Software performance tests conducted by the
manufacturer found that under certain circumstances, compatibility test results
may be posted to another patient’s record.
VOLUME OF PRODUCT IN COMMERCE 3 versions.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Units A213449-1, A213449-2, B205254
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center
& Program, Seattle, WA
REASON Blood products, incorrectly labeled as leukoreduced,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WA.
PRODUCT FlexiLab? Blood Bank and Blood Donor Software
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., Tucson, AZ
REASON Blood bank computer system, which had a software
glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 versions.
DISTRIBUTION Nationwide and Saudi Arabia and the United
Kingdom.
PRODUCT FlexiLab? Laboratory Information System
CODE Versions 5.23 and 5.3 with RBR module.
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., Tucson, AZ
REASON Blood bank computer system, which had a software
glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 versions.
DISTRIBUTION Nationwide and Denmark.
PRODUCT FlexiLab? Blood Bank and Blood Donor Software.
CODE Versions 5.2 and 5.23.
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., Tucson, AZ
REASON Blood bank computer system, which had a software
glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Nationwide and Saudi Arabia, Canada, Ireland
and the United Kingdom.
PRODUCT Recovered Plasma
CODE Unit 4001.
RECALLING FIRM/MANUFACTURER Community Hospital of
Lancaster Blood Bank, Lancaster, PA
REASON Blood product, collected from a donor who had
previously been deferred for failure to complete the confidential unit
exclusion, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Rabies Vaccine, RabAvert
CODE Lot 261011, expires 09.2001 and 09.2003; Lot 273011,
expires 01.2001.
RECALLING FIRM/MANUFACTURER Chiron Corporation,
Emeryville, CA
REASON Drug products, for which sterility cannot be assured
due to evidence of broken or cracked vials, were distributed.
VOLUME OF PRODUCT IN COMMERCE 52,745 vials.
DISTRIBUTION Nationwide.
PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit LH58241-1.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which was labeled as leukoreduced but
had a white cell count that exceeded the specifications for a leukoreduced
product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Platelets, Pooled, Iradiated.
CODE UnitPool Id. P26393
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Pooled unit of Platelets, pooled from five units,
was labeled as having been pooled from six units.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit LN49196.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells; b) Platelets, Pooled
CODE a) Unit FW22414; b) Unit P22751.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood products, collected from a donor who had been
incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and WI.
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma
CODE a), b) and c) Unit 32R 83404.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red
Cross Blood Services, Madison, WI
Manufacturer:
American Red Cross Blood Services, Waterloo, IA.
REASON Blood products, collected from a donor with a
history of having tested positive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WI.
PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated
CODE Unit KM27909-1.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc.,Milwaukee, WI
REASON Blood product, which had a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Units LX92840-1, LH54884-2.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern
Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which had a low platelet counts,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit GR11438.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, collected from a donor with a history
of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Unit 32LP02560.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Madison, WI
REASON Blood product, that was labeled as having been
leukoreduced, did not have a white blood cell count performed prior to
distribution.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells
CODE Unit 32KE42114.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Madison, WI
REASON Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets,
Pooled Unit
CODE a) KZ56941 and b) P11161.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern
Wisconsin, Inc., Milwaukee, WI
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells; b) Platelets.
CODE a) and b) Unit 17KC09962.
RECALLING FIRM/MANUFACTURER American Red Cross North
Central Blood Services, St. Paul, MN
REASON Blood products, collected from a donor who had lived
in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MN.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit T71772.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood products, collected from a donor receiving
Lupron injections, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Wisconsin and Switzerland.
PRODUCT a) Red Ant Extract; b) Red Ant Extract,
CODE a) Lot 5V18, Expiration: August, 2001; b) Lot 7S12,
Expiration: May, 2003.
RECALLING FIRM/MANUFACTURER ALK-Abello, Round Rock, TX
REASON Customers were informed that two different Ant
species were from the same source material.
VOLUME OF PRODUCT IN COMMERCE 42 viles.
DISTRIBUTION Nationwide
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets, Leukocytes Reduced
CODE a) and b) Unit number 17KP84688.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, St. Paul, MN
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 MN.
PRODUCT Red Blood Cells
CODE Unit number 17KR76040.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, St. Paul, MN
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 MI.
PRODUCT Red Blood Cells
CODE Unit number 19244-9069.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Reno, NV.
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
CODE Unit number LP34860.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeast Wisconsin, Inc., Milwaukee, WI
REASON Blood product, that tested reactive for the antibody
to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets, Leukocytes Reduced
CODE a) and b) Unit number 17KT51541.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, St. Paul, MN
REASON Blood products, collected in a manner that may have
compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MN.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 17KY44958 and 17KT52490.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, St. Paul, MN
REASON Blood products, corresponding to units of Platelets
that were pooled and may have been bacterially contaminated with Staphylococcus
epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION SD and WI.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 17KX77106, 17KX77121, 17KX77083,
17KX77072, and 17KX77105.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, St. Paul, MN
REASON Blood products, corresponding to units of Platelets
that were pooled and may have been bacterially contaminated with Bacillus
cereus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION SD and MN.
PRODUCT Red Blood Cells, Leukoreduced
CODE Units 24208-7626.
RECALLING FIRM/MANUFACTURER