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 Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Ventura, CA.
REASON Blood product, that was labeled leukoreduced but was
not tested to determine the white blood cell count as required in the firm's
standard
operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a) Unit numbers 10624-0348 and 21379-0172; b) Unit
number 10624-0348; c) Unit number 10624-0348.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, that tested negative for the
antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but
were
collected
from donors that previously tested repeatedly reactive for anti-HIV-1/2, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AZ and ND.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers 0579882-1, 0579882-2, 0561024, and
0550107.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University
of Cincinnati Medical Center,Cincinnati, 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.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit number 0586270.
RECALLING FIRM/MANUFACTURER University of Cincinnati
Medical Center, Cincinnati, 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 2 units.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit number 2102816.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, 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 2 units.
DISTRIBUTION OH.
PRODUCT Corneas
CODE Donor Identification OS 2001-03-2005 and OD 2001-03-2006.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland
Lions Eye Bank, Columbia, MO
Manufacturer:
Central Illinois Lions Eye Bank, Springfield, IL.
REASON Corneas, collected from a donor who was diagnosed
with suspected, but unconfirmed, Creutzfeld-Jakob Disease (CJD), were
distributed for transplant.
VOLUME OF PRODUCT IN COMMERCE 2 corneas.
DISTRIBUTION KA and MO.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Washed,
Irradiated
CODE a) Units
2713222, 3950690; b) Unit
2732718.
RECALLING FIRM/MANUFACTURER Houchin Blood Services,
Bakersfield, CA
REASON Blood products, collected from a donor who was
taking Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Units 10712566, 10632376, 08047090, 10640333,
08286284, 10630405, 08285003, 10637227, 08282347, 10635964, 08281180, 10633502,
08048486.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec
Biologicals, North Brunswick, NJ
Manufacturer:
Sera-Tec Biologicals, Clearwater, FL.
REASON Blood products, collected from a donor who
previously tested HCV reactive in PCR testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION CA.
PRODUCT Fresh Frozen Plasma
CODE Unit GX34662.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA
REASON Blood product, collected from a donor taking the
drug Lupron, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis
CODE Unit numbers 26161-9057, 26161-9055, 26161-9048,
26161-9037, 26161-9024, 26161-9021, 26161-8910, 26161-8905, 26161-8868,
26161-8805, 26161-8785, 26161-8755, 26161-8701, 26162-6974, 26162-6910,
26162-6883, 26162-6803, 26162-6707, 26164-5704, 26162-4817, 26162-4787,
26162-480,26162-4769, 26162-4715, 26161-4710, 26160-2890, and 26165-2748; the
following unit numbers were distributed as two split products 26161-9063,
26161-8982, 26161-8917, 26161-8869, 26161-8815, 26162-6862,26162-6839,
26162-6819, 26162-4837, 26162-4810, 26162-4707, 26158-4648, 26165-2756,
26165-2755, 26165-2741, and 26165-2738.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort
Smith, AR
REASON Platelets with a platelet count outside the
manufacturer’s specifications were distributed.
VOLUME OF PRODUCT IN COMMERCE 59 units.
DISTRIBUTION MS, AR, TX and OK.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Units 49GR03327, 49LH18661, and 49LH27047; b)
Unit 49GR03327.
RECALLING FIRM/MANUFACTURER The American national Red
Cross, Tulsa, OK
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible
due to a
reported
history of previous reactive testing for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MA, TX, CA, OK.
PRODUCT a) Red Blood Cells, Irradiated; b) Recovered
Plasma
CODE a) and b) Unit 0540807.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, not quarantined after receiving post
donation information related to a tick bite, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and FL.
PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF; c)
Recovered Plasma
CODE a), b) and c) Unit
7841008.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford,
TX
REASON Blood products, collected from a donor who was
taking Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and Switzerland.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a), b) and c) Unit 7841796.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford,
TX
REASON Blood products, collected from a donor whose
hemoglobin was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Platelets Pheresis
CODE (2 split units), unit number 11LS19735.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, St. Louis,
MO
Manufacturer:
American Red Cross Blood Services, Crestwood, MO.
REASON Blood product, labeled with the incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 split units.
DISTRIBUTION MO.
PRODUCT Red Blood Cells
CODE Unit 4197826.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc.,
Anchorage, AK
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 AK.
PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF; c)
Recovered Plasma
CODE a), b) and c) Unit 7837167.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford,
TX
REASON Blood products, collected from a donor who reported
sexual contact with her spouse who had hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and Switzerland.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) and b) Unit 1632203.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood products, collected from a donor who lived in
the United Kingdom for greater than 6 months between 1980-1996, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and WI.
PRODUCT Serum, for Further Manufacturing of Non-Injectable
Products
CODE Unit TT44953.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank,
Inc.(IBBI), Memphis, TN
REASON Blood product, which tested negative for viral
markers, but was collected from a donor whose health history was inadequately
determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Platelet Pheresis Irradiated
CODE Units 007FP09023 (split product), 007FP09025,
007FP09026 (part 1), 007FP09029 (split product).
RECALLING FIRM/MANUFACTURER American National Red Cross,
Arizona Region, Tucson, AZ
REASON Platelets, not stored under continuous agitation,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION AZ.
PRODUCT Liquid Plasma
CODE Unit FF80880.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods,
Santa Rosa, CA
REASON Liquid Plasma, labeled with an incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Recovered Plasma
CODE Units
2834288 and 1105481.
RECALLING FIRM/MANUFACTURER New York Blood Center
(Center West), New York, NY
REASON Blood products, collected from unsuitable donors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Switzerland.
PRODUCT Source Plasma
CODE Units N56918-018 and N56959-018.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha
Therapeutic Corporation, Los Angeles, CA
Manufacturer:
Alpha Therapeutic Corporation, Fresno, CA.
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 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit 10620-9557.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Scottsdale, AZ.
REASON Blood product, labeled with the incorrect
anticoagulant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a) 2133714, 2132904; b) 2133714, 2132904; C)
2133714, 2132904.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH
REASON Blood products, collected from a donor who was
taking the antibiotic, Keflex, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION OH.
PRODUCT Recovered Plasma
CODE Units 2732718, 3950690, 2713222.
RECALLING FIRM/MANUFACTURER Houchin Blood Services,
Bakersfield, CA
REASON Blood products, collected from a donor who was
taking Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) and b) 1637930.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center
(CKBC), Lexington, KY
REASON Blood products, collected from a donor who was
taking Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c)
Fresh Frozen Plasma; d) Recovered Plasma
CODE a) Unit numbers 7892623, 7837690, 7827137, and
7827420; b) Unit number 7827137; c) Unit number 7827420; d) Unit numbers
7892623, 7837690, and 7827137.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
TX
REASON Blood products, collected from donors whose arm
inspection was either not documented or was noted to be unacceptable, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION TX and Switzerland.
PRODUCT Short Ragweed Allergenic Extract
CODE Lot number 7O9F22380.
RECALLING FIRM/MANUFACTURER ALK-Abello, Round Rock, TX
REASON Allergenic extract was distributed labeled with the
incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK, CT, IL, TX, MD, MA, MN, TN and FL.
PRODUCT Source Plasma
CODE Unit 0083827.
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale,
Inc., Carbondale, IL
REASON Blood product, untested for viral markers, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced
CODE a) Units E22201, E22236, G04397, G04401, G04412,
K31631, L34892, L34904, L34905, L34907, L34909, L34910, L34911, L34924, L34928,
L34931,
L34937, L34938, L34943, L34945, L34948, L34952, L34954, L34955, L34958, L34959,
L34960, L34963, L34964, L34966, L34968, L34973, L34974, L34975, L34977, L34980,
L34982, L34988, L34990, L34991, L34992, L34998, L34999, L35020, L35051, L35052,
L35062, L35065, L35070, L35076, L35079, L35080, and L35081; b) Units G04366,
L34884, L34893, L34895, L34897, L34898, L34899, L34900, L34903, L34906, L34908,
L34919, L34920, L34921, L34922, L34926, L34927, L34929, L34930, L34935, L34940,
L34942, L34944, L34961, L34969, L34979, L34984, L34985, L34996, L35000, and
L35001.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, subjected to incorrect storage
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 84 units.
DISTRIBUTION IL.
PRODUCT Platelets
CODE Unit 10632-9138.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
United Blood Services, Scottsdale, AZ.
REASON Platelets, shipped at an unacceptable temperature,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells
CODE Unit 7050978.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, collected from an ineligible donor
due to medication with an antibiotic in the previous 72 hours, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells
CODE Unit 9004553.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc.,
Anchorage, AK
REASON Blood product, that tested positive for unexpected
antibodies to red blood cell antigens, but was labeled negative for unexpected
antibodies,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 10717-4411.
RECALLING FIRM/MANUFACTURER United Blood Services, Scottsdale,
AZ
REASON Blood product, labeled with an extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Platelets, For use in Maufacturing Non-Injectables
CODE Unit 1632203.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood products, collected from a donor who lived in
the United Kingdom for greater than 6 months between 1980-1996, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 units.
DISTRIBUTION TX and WI.
PRODUCT Red Blood Cells (2 units).
CODE Units 7489992, 7413238
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
TX
REASON Blood products, collected from donors whose
hemoglobin counts had not been documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units
DISTRIBUTION TX
PRODUCT Source Plasma
CODE Unit G-66580-77.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., Los
Angeles, CA
REASON Blood product, collected from a donor who had skin
piercing performed within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.
PRODUCT a) Red blood Cells; b) Fresh Frozen Plasma
CODE a) Unit FR03243; b) Unit FR06851.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood products, collected from a donor with a
history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit G-54290-051.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles,
CA
Manufacturer: Alpha Therapeutic Corporation, Fontana, CA
92335
REASON Blood product, collected from a donor with a history
of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit S90062.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
REASON Blood product, that was labeled leukoreduced but had
an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Units T-20466-097, T-20408-097, T-20305-097,
T-20082-097, T-20005-097, T-19838-097, T-19768-097, T-19691-097, T-19625-097,
T-19475-097, T-19440-097, T-19301-097, T-19266-097, T-19038-097, T-18764-097,
T-17876-097, T-17733-097, T-17411-097, T-16703-097, T-16558-097,
T-13952-097,
T-13828-097, T-13661-097, T-13503-097, T-13319-097, T-13138-097, T-12952-097,
T-12798-097, T-12571-097, T-12279-097, G-96207-097, G-95761-097, G-94757-097.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles,
CA
Manufacturer:
Alpha Therapeutic Corporation, San Diego, CA.
REASON Blood products, which tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from a donor that
previously tested reactive to anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION Spain
PRODUCT Source Plasma
CODE Unit 43278527
RECALLING FIRM/MANUFACTURER Plasma Biological Services,
Inc., Memphis, TN
REASON Source Plasma, with an elevated alanine
aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION California
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number 8245160
RECALLING FIRM South Florida Blood Banks,
Inc., West Palm Beach, FL
REASON Blood product, that tested negative for syphilis,
but was collected from an ineligible donor based on previous reactive testing
for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Georgia
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Units 49GR03327, 49LH18661, and 49LH27047; b)
Unit 49GR03327.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southwest Region, Tulsa, OK
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible
due to a reported history of previous reactive testing for anti-HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MA, TX, CA, OK.
PRODUCT Platelet, Pheresis (Split).
CODE Unit 42KF05882
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northern Ohio Region, Cleveland, Ohio
REASON Blood
products, which were labeled as leukoreduced but did not undergo
leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION Ohio
PRODUCT a) Red Blood Cells, Leukocytes Removed; b) Platelets
Pheresis, Irradiated; c) Platelets Pheresis, Leukocytes Removed;
d)
Platelets Pheresis, Irradiated, Leukocytes Removed
CODE a) Unit (1 unit) 03FT57071; b) Unit (1 unit) 03P27096 (part 1); c) Units (15 units)
03P26308 (parts 1 and 2), 03P25910 (parts 1 and 2), 03P25244 (parts 1 and 2),
03P24729 (parts 1 and 2), 03P24437 (parts 1 and 2), 03P24154 (part 2), 03P23553
(parts 1 and 2), 03P23222 (parts 1 and 2); d) Unit (1 unit) 03P27096 (part 2)
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Southern Region, Atlanta, Georgia
REASON Blood products, collected from a donor who was
taking Ridaura for rheumatoid arthritis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION Georgia
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) Unit (1 unit) 5345710; b) Unit (1 unit) 5345710.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford,
TX
REASON Blood products, collected from a donor with a
previous false positive test result, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION Texas
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a) Unit M06614; b) Unit M06614; c) Unit M06614.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.
PRODUCT Source Plasma (29 units)
CODES unit numbers 0450600364, 0450599949, 0450599290,
0450598802, 0450598419, 0450606264, 0450605972, 0450605050, 0450604608,
0450604235, 0450603828, 0450603529, 0450602773, 0450602503, 0450602084,
0450601729, 0450601368, 0450601094, 0450597482, 0450597045, 0450596820,
0450596130, 0450595521, 0450595060, 0450594817, 0450594334, 0450594147, 0450593683,
and 0450593459
RECALLING FIRM/MANUFACTURER Recalling Firm: Nabi, Boca
Raton, FL
Manufacturer:
Nabi, Youngstown, OH.
REASON Blood products, collected from an ineligible donor
due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION South Korea and the United Kingdom.
PRODUCT Source Plasma
CODE Unit G-93925-044
RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid Biological CorporationVan Nuys, CA
Manufacturer: Pyramid Biological Corporation, San Diego,
CA.
REASON Blood product, collected from an ineligible donor
due to the presence of unexplained needle marks, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced (1 unit).
CODE Unit 12FW95875
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Region, 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 North Carolina
PRODUCT a) Red Blood Cells (1 unit); b) Platelets, Pheresis
Leukocytes Removed (1 unit).
CODE a) and b) unit W66927
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
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 Virginia
PRODUCT Red Blood Cells, Leukocytes Removed (1 unit).
CODE Unit GL80645
RECALLING FIRM/MANUFACTURER Blood Bank of San
Bernardino and Riverside Counties, San Bernardino, CA
REASON Blood product, collected from a donor who previously
lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION California
PRODUCT Red Blood Cells (1 unit).
CODE Unit 53FM44312
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD
REASON Blood product, collected from a donor who previously
lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Maryland
PRODUCT a) Red Blood Cells, Leukocytes Reduced (1 unit),; b)
Cryoprecipitated AHF (1 unit),; c) Recovered Plasma (1 unit),
CODE a), b), and c) unit number FJ72754
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, collected from an unsuitable donor
based on a medical history of the disease Polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Florida, Rhode Island, and Switzerland,
PRODUCT a) Red Blood Cells (2 units; b) Platelets,
Pooled (1 unit; c) Cryoprecipitated AHF
(1 unit); d) Fresh Frozen Plasma (1
unit)
CODE a) Units 0476135, 0461226; b) Unit 0461226 (pool
number - 0070014); c) unit 0461226; d) unit 0476135
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from a donor who received
a human bite within the last 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION Ohio, Florida, and Kentucky
PRODUCT Platelet, Pheresis, Leukoreduced (Split)
CODE Unit 10715-4536.
RECALLING FIRM/MANUFACTURER United Blood Services,
Scottsdale, AZ
REASON Blood products, which were labeled as leukoreduced
but did not meet the standard for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Unit 53P82401.
RECALLING FIRM/MANUFACTURER American Red Cross,
Baltimore, MD
REASON Blood product, labeled with extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT a) Red Blood Cells (1 unit); b) Platelets,
Irradiated (1 unit); c) Platelets Pheresis (1 unit); d) Platelets Pheresis,
Irradiated (1 unit).
CODE a)and b) unit number M88417; c) and d) unit number
W65868.
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 Virginia
PRODUCT a) Red Blood Cells (2 units); b) Platelets (2
units),
CODE a) and b) unit numbers M87464 and C44135.
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 Virginia
PRODUCT Red Blood Cells
CODE Unit number W17169
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 Virginia
PRODUCT Red Blood Cells
CODE Unit number 53L31073
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Chesapeake and Potomac Region, Baltimore, MD
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 Maryland
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 13GC93156
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
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 Michigan
PRODUCT a) Red Blood Cells (1 unit); b) Recovered Plasma (1
unit)
CODE a) and b) unit number 084FT13238
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region,
Oakland, CA
REASON Blood products, collected from an ineligible donor
due to a history of medication with human growth hormone, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units
DISTRIBUTION California and Maryland
PRODUCT a) Red Blood Cells, Leukocytes Removed; b)Recovered
Plasma
CODE a)Unit
10709-3995; b)Unit 10709-3995
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ
REASON Blood products, collected from a donor whose skin
disease status had not been accurately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells
CODE Unit 13FF27987.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Southeastern Region, Detroit, MI
REASON Red Blood Cells, incorrectly phenotyped for the
Fy(a) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Plasma CryoReduced
CODE Units 11FF68858, 11GL31717, 11GZ21406, 11GL31753,
GL31726,11GQ28023, 11GV26567, 11GQ28013, 11GQ28020, 11GL31759, 11GN35708,
11FM61901, 11GQ28021, 11GN35740, 11GN35449, 11GN35737.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Blood products, lacking assurance of proper
temperature storage during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 Units.
DISTRIBUTION GA.
PRODUCT a) Platelet Pheresis; b) Platelet Pheresis,
Leukoreduced
CODE a) Unit 0430100; b) Unit 0430101.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, Ohio
REASON Plateletpheresis products, lacking platelet count
determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Platelets Pheresis, Leukocyte Reduced
CODE Units 03P21270, 03FG16013, 03FL84241, 03FL84249,
03FL84267, 03FZ08125, 03KR06923, 03LL12267, 12GP28143, 12KG50372, 03FG16098,
03F09811, 03KR06985, 03LL12324, 03F10115, 03FK19610, 03FL84186.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Blood products, exposed to unacceptable storage
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 Units
DISTRIBUTION GA.
PRODUCT Red Blood Cells
CODE Units 04Q988444, 04Q986186, 04Q988143, 04Q988223,
04Q988272, 04Q981990, 04Q96382X,
04Q985245.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Gainesville, FL
Collection/Processing
site: Civitan Regional Blood Center,
Ocala, FL.
REASON Blood products, labeled with extended expiration
dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION FL and AL.
PRODUCT Source Plasma
CODE Unit LA-51839.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid
Biological Corporation, Van Nuys, CA
Manufacturer: Pyramid Biological Corporation, Las Vegas,
NV
REASON Blood product, collected from a donor whose arm
inspection was incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Removed (1 unit)
CODE Unit 12GY36547
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Region, Charlotte, NC
REASON Red Blood Cells, incorrectly tested for Jsa and
labeled Jsa negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION North Carolina
PRODUCT Platelets (1 unit)
CODE Unit number 12453-4695
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Albuquerque, NM.
REASON Blood product, exposed to unacceptable temperatures,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION New Mexico
PRODUCT a) Red Blood Cells (1 unit); b) Red Blood Cells,
Leukocytes Reduced (15 units); c) Cryoprecipitated AHF (7 units); d) Cryoprecipitated
AHF, Pooled (3 pools); e) Recovered Plasma (19 units).
CODE a) unit number 21GS09406;
b)
unit numbers 21GS09407, 21GS09408, 21GS09409, 21GS09410, 21GS09411, 21GS09412,
21GS09413, 21GS09414, 21GS09415, 21GS09416, 21GS09419, 21GS09421, 21GS09422,
21KE09671, and 21KE09673
c)
unit numbers 21GS09406, 21GS09408, 21GS09409, 21GS09412, 21GS09413, 21GS09419,
and 21GS09421
d)
pool numbers 4185 (contained recalled units 21GS09407, 21GS09410, 21GS09411,
21GS09415, and 21GS09416), 4158 (contained recalled unit
21GS09414),
and 4160 (contained recalled unit 21GS09422)
e)
unit numbers 21GS09406, 21GS09407, 21GS09408, 21GS09409, 21GS09410, 21GS09411,
21GS09412, 21GS09413, 21GS09414, 21GS09415, 21GS09416, 21GS09417, 21GS09418,
21GS09419, 21GS09421, 21GS09422, 21KE09671, 21KE09673, 21KE09674
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Pacific Northwest Region, Portland, OR
REASON Blood products, manufactured from units of Whole
Blood shipped at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units
DISTRIBUTION Alaska, Washington, Oregon, California, and
Switzerland