DECEMBER 2001
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Platelets; d) Fresh Frozen Plasma
CODE a) Unit 07FK18764; b) Unit 07FG66060; c) Unit
07FG52378; d) Units 07FG66060, 07FG52378.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Tucson, AZ
REASON Blood products prepared from overweight units of
whole blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AZ.
PRODUCT Platelets, Pheresis
CODE Units KT23552P1,
KT23552P2.
RECALLING FIRM/MANUFACTURER Southern California
Permanente Medical Group, Los Angeles, CA
REASON Blood products, which had unacceptable platelet
counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT a) Platelets, Pheresis, Leukocytes Reduced; b)
Platelets, Pheresis, Leukocytes Reduced Irradiated
CODE a) Units 8787307, 6243364; b) Units 2265360,
6243364.
RECALLING FIRM/MANUFACTURER New York Blood Center
(Center West), A Division of New York Blood Center, Inc., New York, NY
REASON Blood products, which had unacceptable platelet
counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY.
PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Units (7 units) 6243124 (bags 1 and 2), 6243128
(bags 1 and 2), 2265125 (bags 1 and 2), 8788344 (bag 2).
RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center (Center West), A
Division of New York Blood Center, Inc., New York, NY
Manufacturer:
New York Blood Center/Hudson Valley Blood Services, A Division of New York
Blood Center, Inc., Elmsford, NY.
REASON Blood products, which had unacceptable platelet
counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION NY.
PRODUCT Counterfeit Neupogen (Filgrastim)
CODE Labeled as containing 300 mcg/1.0 ml, packaged
10/1.0 ml. single use vials per box.
Lot Number P000890, Expiration Date 12/02,
Lot
Number P000992, Expiration Date 06/03, Lot Number P000948, Expiration Date
05/03, Lot Number P000954, Expiration Date 05/03.
Quantity
of counterfeit units distributed can not be determined.
RECALLING
FIRM AmeriSourceBergen, AmeriSource, Inc., Paducah, KY
REASON Counterfeit Neupogen was distributed.
VOLUME OF PRODUCT IN COMMERCE Quantity of counterfeit
units distributed can not be determined.
DISTRIBUTION IN, KY, AR, LA, TN, MS, AL, MO.
PRODUCT Platelets, Irradiated
CODE Unit 03GZ26906.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Atlanta, GA
REASON Blood product, for which documentation of irradiation
was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Platelets, Pheresis
CODE Unit
01FP12102.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red
Cross Blood Services, West Henrietta, NY
Manufacturer: American Red Cross Blood Services, Albany,
NY
REASON Blood products, which were labeled as leukoreduced,
but failed the quality control specification for white blood cell count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT Platelets, Irradiated
CODE Units 03E21742, 03GG75545.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Atlanta, GA
REASON Blood products, for which documentation of
irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION GA.
PRODUCT a) Red Blood
Cells; b) Red Blood Cells,
Leukoreduced; c) Platelets; d) Fresh Frozen Plasma
CODE a) Unit L20561; b) Unit L24918; c) Unit L24918; d)
Unit L20561, L24918.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, collected from a donor taking the
drug Nardil, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION IL and VA.
PRODUCT Red Blood Cells
CODE Unit 1127467.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Dayton, OH
REASON Blood product, collected from a donor taking the
drug Agrylin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Red Blood
Cells, Leukocytes Reduced Irradiated;
c) Platelets
CODE a) Unit number 01FF36700; b) Unit number 01E46286;
c) Unit number 01E46286.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, West Henrietta, NY
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 3 units
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets
CODE a) Unit 01KH31923; b) Unit 01KH44532 and 01KH37026;
c) Unit 01KH31923.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, West Henrietta, NY
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 NY and PA.
PRODUCT Cornea (1 tissue
CODE ID number NE-01-07-037-R-1.
RECALLING FIRM/MANUFACTURER New England Eye and Tissue Transplant
Bank, Boston, MA
REASON Human tissue for transplantation was distributed
untested by licensed donor screening tests for human immunodeficiency virus,
types
1 and 2 (HIV-1/2), hepatitis B virus (HBV), and hepatitis C virus (HCV).
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION MA.
PRODUCT Red Blood Cells
CODE Unit 04L613416.
RECALLING FIRM/MANUFACTURER Civitan Regional Blood
Center, Inc., Gainesville, FL
REASON Blood product, that tested initially reactive for
the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit 12GM69795.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Charlotte, NC
REASON Blood product, collected from an ineligible donor
due to a history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Frozen
Plasma
CODE a) Unit 29KN24189; b) Unit 29KN24189.
RECALLING FIRM/MANUFACTURER American Red Cross ,
Norfolk, VA
REASON Blood products, collected from a donor who had
undergone a splenectomy, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA and MD.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma
CODE a) Units 18FW18046, 18FC52069, 18E52918, and
18Z54170; b) Units 18FC52069 and 18E52918; c) Unit 18FC52069;
d)
Units 18FW18046 and 18E52918.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lansing, MI
Manufacturer:
American Red Cross Blood Services, Muskegon, MI
REASON Blood products, collected from an ineligible donor
due to medication with the drug Tamoxifen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION MI, MA, TN and Switzerland.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit 18GN04983, 18GN04984, 18GN04985, 18GN04989,
18GN04990, 18GN04995, 18GN04996, 18GN04997, 18GN04998 and 18GN04999;
b) Unit 18FJ40541, 18GN04983, 18GN04984,
18GN04985, 18GN04986, 18GN04989, 18GN04990, 18GN04995, 18GN04997 and 18GN04999.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Lansing, MI
REASON Blood products, manufactured in a centrifuge that
failed to maintain proper temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION MI, IN and Switzerland.
PRODUCT Red Blood Cells
CODE Unit FR06851 (two split units distributed).
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood products, labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Red Blood Cells, Unit 04L572282; b) Recovered
Plasma, Unit 04L572282.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Gainesville, FL
REASON Blood products, which were collected from a donor
who had an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION GA and CA.
PRODUCT Recovered Plasma
CODE Unit 22411-4126.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las
Vegas, NV
REASON Blood product, which was collected in a manner that
possibly compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit FM88429; b) Unit FM88429.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton,
CA
REASON Blood products, which were collected from donor whose
health history was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit 04L703004.
RECALLING FIRM/MANUFACTURER Civitan Regional Blood
Center, Inc., Gainesville, FL
REASON Blood product, that tested initially reactive for
the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
WEEK
ENDING DECEMBER 8
PRODUCT Red Blood Cells
CODE Unit C42199.
RECALLING FIRM/MANUFACTURER Southeastern Community Blood
Center, Tallahassee, FL
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 GA.
PRODUCT Diagnostic Leukocytes
CODE Unit UA15590.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc.,
Memphis, TN
REASON Blood product, which tested RPR reactive for
syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT Source Plasma
CODE Unit A00443370.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Hoover, AL
REASON Blood product, incorrectly for hepatitis B surface
antigen(HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Platelets, Pheresis
CODE Unit 02P50305.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Wichita, KS
REASON Blood product, incorrectly labeled as leukoreduced,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets
CODE a) Unit 1742247; b) Unit 1794288; c) Unit 1794288.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Inc., Lexington, KY
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 3 units.
DISTRIBUTION KY.
PRODUCT Platelets Pheresis
CODE Unit 02P48721.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Wichita, KS
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 KS.
PRODUCT Red Blood Cells, Leukocytes
CODE Unit 02FC75813, 02FC73354, 02FC70562, and 02FC67087.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Wichita, KS
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 KS.
PRODUCT Fresh Frozen Plasma
CODE Units 1737956, 1741856.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center (CKBC), Lexington, KY
REASON Blood products, which may have been incorrectly
tested for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.
PRODUCT Source Plasma
CODE Units
T-12787-097, T-12710-097, T-12481-097, T-12416-097, T-11827-097 T-11741-097, T-11570-097, T-11502-097,
T-11357-097,
T-11291-097 T-11094-097, T-11032-097, T-10914-097,
T-10847-097, T-10177-097 T-09985-097,
T-09844-097, T-09543-097, T-09470-097,
T-09254-097,
T-09217-097, T-08807-097, T-08550-097, T-08443-097, T-08233-097 T-08140-097, T-07961-097, T-07880-097,
T-07686-097, T-07611-097 T-07369-097,
T-06962-097, G-90994-097, G-90751-097, G-90182-097 G-89932-097, G-89377-097, G-89129-097, G-88022-097,
G-87701-097 G-87048-097, G-86672-097,
G-85926-097, G-85494-097, G-84844-097
G-84449-097, G-83092-097, G-82827-097, G-82031-097, G-81782-097 C-32744-097, C-32687-097, C-32670-097,
C-32617-097, C-32597-097, C-32530-097,
C-32492-097, C-32439-097.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles, CA
Manufacturer: Alpha Therapeutic Corporation, San Diego, CA
REASON Blood products, collected from a donor who had a
tattoo within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 58 Units.
DISTRIBUTION MD and Spain.
PRODUCT Platelets Pheresis
CODE Units 0055517, 0055550, 0056230, 0056244, 0056343,
0056346, 0056396, 0056842, 0056847, 0056964, 0056967, 0056982, 0056993,
0057000, 0057003, 0057006, 0057008, 0057034, 0057181, 0057182, 0057187,
0057190, 0057213, 0057196, 0057202, 0058098, 0058114, 0058133, 0058789,
0058792, 0058814, 3809306, 3809308, 3809318, 3809335, 3862248, 3862630,
3873321, 3873328, 3873372, 3873690, 3874104, 3874105, 3874137, 3874138,
3874139, and 3852664; (the following unit numbers were distributed as two split
units) 0055514, 0055527, 0055528, 0055579, 0056239, 0056362, 0056368, 0056370,
0056373, 0056401, 0056624, 0056662, 0056873, 0056965, 0057004, 0057026,
0057032, 0057049, 0057191, 0057192, 0057200, 0057230, 0058827, 3809323, 3809328,
3844324, 3862621, 3862632, 3873318, 3873325, 3873329, 3873362, 3873368,
3873374, 3874119, 3874124, 3874134, and 3874135.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Lubbock, TX
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 123 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells
CODE Units 0150729, 0011747, 0268889.
RECALLING FIRM/MANUFACTURER Recalling Firm: New York
Blood Center, Inc., New York, NY
Manufacturer:
Stichting Sanguine Bloodvoorziening/CLB, Amsterdam, Netherlands.
REASON Blood products, that tested negative for viral
markers, but were collected from ineligible donors based on: 1) previous
repeatedly reactive testing for the antibody to hepatitis C virus (anti-HCV);
or 2) the application of a tattoo within the previous 12 months, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NY and NJ.
PRODUCT Red Blood Cells
CODE Units 0303126, 0319174, 0313640, 0302536, 0329989,
0308413, 0308737, 0310730, 0313982, 0306639, 9615611, and 0309772.
RECALLING FIRM/MANUFACTURER Recalling Firm: New York
Blood Center, Inc., New York, NY
Manufacturer:
Stichting Sanguine Bloodvoorziening/CLB, Amsterdam, Netherlands.
REASON Blood product, that tested negative for viral
markers, but were collected from ineligible donors based on previous reactive
testing for the antibody to hepatitis C virus (anti-HCV), the antibody to human
immunodeficiency virus (anti-HIV), or syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION NY and NJ.
PRODUCT Red Blood Cells;Platelets
CODEUnit 01LC30728;Unit 01LC30728.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, West Henrietta, NY
REASON Blood product, that tested negative for
Cytomegalovirus (CMV), but were collected from a donor who previously tested
CMV positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT Source Plasma
CODE Units LP-21937, LP-21695, LP-15834, and LV-20878.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid
Biological Corporation, Van Nuys, CA
Manufacturer:
Pyramid Biological Corporation, Las Vegas, NV
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 4 units.
DISTRIBUTION Germany and Austria.
PRODUCT Fresh Frozen Plasma
CODE Unit 084GS13208.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Oakland, CA
REASON Blood product, whose collection time exceeded the
maximum time in the firm’s standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit 5404617.
RECALLING FIRM/MANUFACTURER Southeastern Community Blood
Center, Tallahassee, FL
REASON Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit 02FG92721.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Wichita, KS
REASON Blood product, that was labeled as leukoreduced but
failed quality control testing due to an elevated white blood cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.
PRODUCT Red Blood Cells (183 units)
CODES Units 9609957, 9609960, 9609961, 9609962, 9609964,
9609965, 9609966, 9609967, 9609968, 9609969, 9609970, 9609971, 9609972,
9609973, 9609974, 9609975, 9609977, 9609978, 9609979, 9609980, 9609983,
9609984, 9609985, 9609988, 9609989, 9609990, 9609991, 9609992, 9609993,
9609996, 9609997, 9610000, 9611206, 9611207, 9611209, 9611210, 9611211,
9611212, 9611213, 9611215, 9611216, 9611217, 9611218, 9611220, 9611221,
9611222, 9611223, 9611224, 9611225, 9611226, 9611227, 9611228, 9611229,
9611232, 9611233, 9611234, 9611235, 9611237, 9611238, 9611239, 9611240,
9611241, 9611242, 9611243, 9611245, 9611246, 9611247, 9611248, 9611249,
9611250, 9611252, 9611256, 9611257, 9611258, 9611259, 9611261, 9611262,
9611263, 9611264, 9613001, 9613004, 9613006, 9613007, 9613008, 9613009,
9613010, 9613012, 9613013, 9613014, 9613015, 9613016, 9613017, 9613018,
9613019, 9613020, 9613021, 9613024, 9613025, 9613028, 9613031, 9613032,
9613033, 9613034, 9613036, 9613038, 9613039, 9613040, 9613041, 9613042,
9613045, 9613046, 9613047, 9613048, 9613049, 9613050, 9613051, 9613052,
9613053, 9613054, 9613055, 9613056, 9613057, 9613058, 9613060, 9613062,
9613063, 9613064, 9613907, 9613908, 9613909, 9613910, 9613911, 9613912,
9613914, 9613915, 9613916, 9613917, 9613918, 9613920, 9613921, 9613922,
9613923, 9613925, 9613926, 9613927, 9613936, 9613938, 9613939, 9613940,
9613941, 9613943, 9613947, 9613948, 9613953, 9613954, 9613955, 9613956,
9613957, 9613958, 9613959, 9613960, 9613961, 9613962, 9613963, 9613964,
9616288, 9616289, 9616291, 9616294, 9616297, 9616300, 9616301, 9616302,
9616305, 9616308, 9616310, 9616312, 9616313, 9616319, 9616320, 9616322,
9616325, and 9616326.
RECALLING FIRM/MANUFACTURER New York Blood Center, Inc.,
New York, NY
REASON Blood products, labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 183 units.
DISTRIBUTION NY and NJ.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) Units 1742066, 1732834, 1746885, 1742046,
1737990, 1748134, 1737956, 1751321, 1743575, 1751459, 1734953, 1752154,
1748226, 1741856; b) Units 1742066, 1751459, 1734953, 1741856.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Blood product, which may have been incorrectly
tested for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION KY.
PRODUCT Source Plasma
CODE Unit 43275632.
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Blood product, that tested negative for the antibody
to hepatitis C virus (anti-HCV), but was not properly quarantined after the
receipt of subsequent repeatedly reactive anti-HCV results for the donor of the
unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 41327593.
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Blood product, that tested negative for the antibody
to hepatitis C virus (anti-HCV), but was not properly quarantined after the
receipt of subsequent repeatedly reactive anti-HCV results for the donor of the
unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 43277377.
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Blood product, that tested negative for the antibody
to hepatitis C virus (anti-HCV), but was not properly quarantined after the
receipt of subsequent repeatedly reactive anti-HCV results for the donor of the
unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
WEEK ENDING DECEMBER 15
PRODUCT Red Blood Cells, Leukocyte Reduced
CODE Unit 24KH65881.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Louisville
REASON Blood product, collected from a donor who reported
living in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells
CODE Unit 03FW70999.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
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 GA.
PRODUCT Red Blood Cells
CODE Unit 12R07885.
RECALLING FIRM/MANUFACTURER American Red Cross,
Charlotte, NC
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 TN.
PRODUCT Red Blood Cells
CODE Unit 03LF11270.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Blood product, collected from a donor who reported living
in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 03GL56010.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Red Blood Cells, collected from a donor whose
hemoglobin level was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT a) Red Blood Cells; b)Platelets; c)Fresh Frozen
Plasma; d)Recovered Plasma
CODE a) Units 03T54633, 03GG03351, 03GG05098,
03GG08739 03R67492; b) Units 03T54633,
03GG03351, 03GG05098, 03R67492;
c)
Unit 03R67492; d) Units 03T54633, 03GG03351, 03GG05098, 03GG08739.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Blood products, collected from donors whose HBsAg
confirmatory test result required reclassification, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION GA, VA and CA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells Leukoreduced
CODE a) Units 21GL60594, 21GL60595, 21GL60596, 21GL60599,
21GL60600, 21GL60602, 21GL60605, 21GL60606, 21GL60607, 21GL60608, 21GL60610,
21GL60613, 21GL60616, 21GL60617, 21GL60618, 21GL60620, 21GL60626, 21GL60630,
21GL60631, 21GL60632, 21GL60633, 21GL60635, 21GL60636; b) Units 21GL60625,
21GL60627.
RECALLING FIRM/MANUFACTURER American Red Cross,
Portland, OR
REASON Blood products, tested with improperly handled
sample tubes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION OR and WA.
PRODUCT Fresh Frozen Plasma
CODE Units 03GF67389 and 03GF67379.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta
GA
REASON Blood products, improperly collected due to an
inadequate arm scrub, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION GA.
PRODUCT Source Plasma Units
CODE G-23463-009, G-22789-009,G-22518-009,
G-23686-009 G-24317-009, G-24521-009, G-25092-009, T-61417-009,
T-61480-009, T-61510-009, T-61667-009, T-61707-009, T-61794-009, T-61828-009,
T-61933-009, T-62019-009, T-62232-009, T-62372-009, T-62451-009, T-62639-009,
T-62749-009, T-62932-009, T-63125-009, T-63268-009, T-63442-009, T-63987-009,
T-64090-009, T-64284-009, T-64385-009,
T-64586-009, T-64694-009,
T-64902-009,
T-64999-009, T-65203-009, T-65340-009, T-65484-009, T-65589-009, T-65747-009,
T-65846-009, T-65998-009, T-66094-009, T-66248-009, T-66322-009, T-66482-009,
T-66548-009, T-66706-009, T-66762-009, T-66930-009, T-66982-009, T-67129-009,
T-67263-009, T-67324-009, T-67449-009, T-67950-009, T-68033-009, T-68135-009,
T-68178-009, T-68281-009, G-45655-009, G-45980-009, G-46498-009, G-46699-009,
G-47500-009, G-47710-009, G-48107-009, G-48292-009, G-52270-009, G-52425-009,
G-52844-009, G-53012-009, G-53605-009, G-54062-009, G-54213-009, G-55115-009,
G-55665-009, G-55849-009, G-56255-009, G-56452-009, G-56850-009, G-57062-009,
G-57525-009, G-57770-009.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles, CA
Manufacturer: Alpha Therapeutic Corporation, Tacoma, WA.
REASON Blood products, collected from a donor who engaged
in high risks behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 82 units.
DISTRIBUTION NC, CA and the United Kingdom, Spain and
Italy.
PRODUCT a) Platelets, Pheresis, Leukocytes Reduced; b) Platelets,
Pheresis, Irradiated
CODE a) Unit 7223028 (Bag 1 and 2); b) Unit 1602761 (Bag
1 and 2).
RECALLING FIRM/MANUFACTURER Recalling Firm: New York
Blood Center, New York, NY
Manufacturer:
New York Blood Center/Long Island Blood Service, A Division of New York Blood
Center, Inc.,Melville, NY.
REASON Blood products, which had unacceptable platelet
counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 42FW79542.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood product, which had a hematocrit value that was
greater than 80%, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) Unit 0482950, 0439270; b) Unit 0482950.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center ,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from a donor taking the
drug Remeron, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY and OH.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit S78769; b) Unit S78769.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA
REASON Blood products, collected from a donor who had skin
piercing performed within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 41634714.
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Blood product, collected from a donor who had a
tattoo within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 10175071,10171653.
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Blood products, which tested negative for antibody
to hepatitis C virus (anti-HCV), but collected from a donor that previously
tested repeatedly reactive, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis, Leukocytes Removed
CODE Unit FF81688.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods,
Santa Rosa, CA
REASON Blood product, not tested for Auszyme (HBsAg), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Units
G-33919-096, G-38476-096, G-38902-096, G-39805-096, G-40228-096,
G-41258-096, G-41684-096, G-42843-096, G-43173-096, G-44343-096, G-44700-096,
G-47401-096, G-47789-096, G-48943-096, G-49931-096, G-54483-096, G-54851-096,
G-63603-096, G-63913-096, G-65750-096, G-
66052-096,
G-67139-096, G-71234-096, G-71602-096, G-74597-096, G-75678-096, G-76152-096.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles, CA
Manufacturer:
Alpha Therapeutic Corporation, Bakersfield, CA.
REASON Source Plasmas, collected from an ineligible donor,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION NC.
PRODUCT Source Plasma, for Further Manufacturing
CODE Units 6070AM, 6557AM.
RECALLING FIRM/MANUFACTURER Southern Plasma Corporation,
Tallahassee, FL
REASON Blood products, collected from a donor who tested positive
for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Platelets
CODE Unit 1812785.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Platelets, collected from a donor who had taken an
aspirin product within 36 hours of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT a) Red Blood Cells, Leukocyte Reduced; b) Fresh
Frozen Plasma
CODE a) Unit 07FK47364; b) Unit 07FK47364.
RECALLING FIRM/MANUFACTURER American National Red,
Tucson, AZ
REASON Blood products, collected from a donor who
previously tested reactive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells
CODE Unit 02FM22363.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Wichita, KS
REASON Blood product, not properly quarantined after
receiving information concerning post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.
PRODUCT Red Blood Cells, Leukocytes Removed
CODE Unit 02W33212.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Wichita, KS
REASON Blood product, collected from a donor who had no hematocrit
check performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.
PRODUCT Recovered Plasma
CODE Units 1560655, 1106942, 1472777.
RECALLING FIRM/MANUFACTURER New York Blood Center, New
York, NY
REASON Blood products, collected from unsuitable donors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Switzerland.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit 36259-2826.
RECALLING FIRM/MANUFACTURER Reca