NOVEMBER 2003

WEEK ENDING NOVEMBER 1

PRODUCT Red Blood Cells.
CODE Units 6801119, 6801120, 6801121, 6801123, 6801126, 6801127, 6301129, 6801130, 6801131, 6801132, 6801134, 6801135, 6801136, 6801137, 6801138.
RECALLING FIRM/MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc, Tyler, TX.
REASON Blood products, manufactured from Whole Blood units that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Units 042Q77979, 042J44316.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 18230-4015.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is ongoing.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and WY.

PRODUCT Source Plasma.
CODE Unit CD0122147.
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, LLC, Carbondale, IL
REASON Blood product, collected in a manner that compromises the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Irradiated.
b) Platelets.
CODE a) and b) Unit (1 unit) 8404938.
RECALLING FIRM/MANUFACTURER Texoma Regional Blood Center, Sherman, TX.
REASON Blood products, collected from a donor who had a tattoo applied within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) Unit numbers 16GJ17887 and 16GJ14754;
b) unit number 16GJ14754.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Ohio Region, Columbus, 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 3 units.
DISTRIBUTION OH.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 50P36733.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE
a) Unit numbers FL04548, FL04549, FL04550, FL04551, FL04552, FL04553, FL04554, FL04556, FL04557, FL04558, FL04559, FL04560, FL04561, FL04562, FL04563, FL04565, FL04566, FL04567, FL04568, FL04569, FL04570, FL04572, FS49928, FS49929, FS49930, FS49932, FS49933, FS49935,
FS49936, FS49937, FS49939, FS49940, FS49942, FS49943, FS49944, FS49945, FS49948, FS49949, FS49951, FT03896, FT03899, FT03903, FT03904, FT03906, FT03907, FT03908, FT03909, FT03910, FT03911, FT03912, FT03913, FT03914, FT03915, FT03916, FT03917, FT03918, FT03919, T03920, FT03921, FT03923, FT03924, FT03925, FT03926, FT03927, FT03928, FV01059, FV01060, FV01062, FV01063, FV01064, FV01065, FV01066, V01067, FV01068, FV01069, FV01070, FV01071, FV01074, FV01075, FV01076, FV01078, FV01080, FV01081, FV01082, FV01083, FV01084, FV01085, V01087, FV01088, FV01090, FV01092, FV01093, FV01096, FV01099, FV01100, FV01101, FV01103, GG73880, GG73881, GG73882, GG73884, G73885, GG73886, GG73887, GG73889, GG73891, GG73892, GG73893, GG73894, GG73895, GG73896, GJ73538, GJ73539, GJ73541, GJ73543, J73544, GJ73545, GJ73551,
GJ73552, GJ73554, GJ73555, GJ73556, GJ73560, GJ73562, GJ73563, GJ73565, GJ73567, GJ73569, GJ73572, GJ73574, GL09831, GL09832, GL09833, GL09834, GL09835, GL09836, GL09837, GL09838, GL09839, GL09840, GL09841, GL09843, GL09844, GL09845, GL09847, GL09849, GL09850,

GL09851, GL09852, GL09853, GL09854, GL09855, GL09857, GL09858, GL09860, GL09862, GL09864, GL09865, GL09866, GL09867, GL09868, GL09869, L09870, GL09871, GL09872, GL09873, GL09875, GL09876, GL09877, GL09880, GL09881, GL09882, GP50079, GP50080, GP50082, GP50083, KJ52664, KJ52665, KJ52666, KJ52667, KJ52668, KJ52670, KJ52671, KJ52672, KJ52673, KJ52674, KJ52676, KJ52677, KJ52678, KJ52679, KJ52680, KJ52681, KJ52682, KJ52683, KJ52685, KJ52686, KJ52688, KJ52689, KJ52690, KJ52691, KJ52692, KJ52693, KJ52752, KJ52753, KJ52754, KJ52755, KJ52756, KJ52757, KJ52760, KJ52761, KJ52762, KJ52763, KJ52764, KJ52765, KJ52767, KJ52768, KJ52769, KJ52770, KJ52771, KJ52772, KJ52773, KL06919, KL06920, KL06921, KL06922, KL06923, KL06924, KL06925, KL06927, KL06928, KL06929, KL06930, KL06931, KL06932, KL06933, KL06934, KL06937, KL06938, KL06939, KL06940, KL06941, KL06942, KL06943, KL06944, KL06945, KL06946, KL06947, KL06948, KL06949, KL06950, KL06951, KL06952, KL06953, KL06954, KL06955, KL06956, KL06957, KL06958, KL06959, KL06960, KL06961, KL06962, KL06963, KL06964, KL06965, KL06966, KL06967, KL06968, KL06969, KL06970, KL06971, KL06980, KL06981, KL06982, KL06983, KL06984, KL06985, KL06986, KL06987, KL06988, KL06989, KL06990, KL06991, KL06993, KL06994, KL07043, KL07044, KL07045, KL07046, KL07048, KL07049, KL07050, KL07051, KL07052, KL07054, KL07055, KL07056, KL07057, KL07058, KL07060, KL07061, KL07062, KL07063, KL07064, KL07065, KL07066, KL07085, KL07090, KM06215, KM06216, KM06217, KM06218, KM06219, KM06220, KM06222, KM06223, KM06224, KM06225, KM06226, KM06227, KM06228, KM06229, KM06230, KM06231, KM06232, KM06233, KM06234, KM06235, KM06236, KM06237, KM06239, KM06241, KM06242, KM06243, KM06244, KM06245, KM06246, KM06247, KM06251, KM06252, KM06254, KM06255, KM06256, KM06257, KM06258, KM06260, KM06261, KM06262, KS66762, KS66763, KS66764, KS66765, KS66766, KS66767, KS66768, KS66770, and KS66771;
b) Unit numbers FL04548, FL04549, FL04550, FL04551, FL04553, FL04554, FL04558, FL04560, FL04561, FL04562, FL04563, FL04565, FL04566, FL04568, FL04569, FL04572, FS49928, FS49929, FS49930, FS49932, FS49933, FS49934, FS49935, FS49936, FS49937, FS49939, FS49940, FS49942,
FS49943, FS49944, FS49945, FS49947, FS49948, FS49949, FS49950, FS49951, FT03896, FT03903, FT03904, FT03906, FT03907, FT03908, FT03909, FT03910, FT03911, FT03912, FT03913, FT03914, FT03915, FT03916, FT03917, FT03918, FT03919, FT03920, FT03921, FT03923, FT03924, FT03925, FT03926, FT03927, FT03928, FV01059, FV01062, FV01064, FV01065, FV01067, FV01068, FV01069, FV01070, FV01071, FV01072, FV01073, FV01074, FV01075, FV01078, FV01079, FV01080, FV01082, FV01084, FV01085, FV01088, FV01090, FV01091, FV01093, FV01095, FV01096, FV01098, FV01099, FV01101, FV01102, FV01103, FV01104, GG73889, GG73890, GG73891, GG73892, GG73893, GG73894, GG73895, GG73896, GJ73538, GJ73541, GJ73542, GJ73543, GJ73545, GJ73549, GJ73551, GJ73552, GJ73554, GJ73556, GJ73557, GJ73562, GJ73563, GJ73565, GJ73567, GJ73568, GJ73569, GJ73571, GJ73572, GJ73574, GJ73575, GL09831, GL09832, GL09833, GL09834, GL09835, GL09836, GL09837, GL09838, GL09839, GL09840, GL09841, GL09843, GL09844, GL09845, GL09847, GL09849, GL09850, GL09851, GL09852, GL09853, GL09854, GL09855, GL09857, GL09858, GL09860, GL09864, GL09865, GL09866, GL09867, GL09868, GL09869, GL09870, GL09873, GL09877, GL09880, GL09881, GP50079, GP50080, GP50082, GP50083, KJ52665, KJ52666, KJ52667, KJ52668, KJ52670, KJ52671, KJ52672, KJ52673, KJ52674, KJ52676, KJ52677,
KJ52678, KJ52679, KJ52680, KJ52681, KJ52682, KJ52684, KJ52685, KJ52686, KJ52687, KJ52688, KJ52689, KJ52690, KJ52691, KJ52692, KJ52693, KJ52752, KJ52753, KJ52754, KJ52755, KJ52756, KJ52758, KJ52759, KJ52760, KJ52761, KJ52763, KJ52764, KJ52765, KJ52767, KJ52769, KJ52770,
KJ52771, KJ52772, KJ52773, KL06920, KL06921, KL06922, KL06923, KL06924, KL06925, KL06927, KL06929, KL06930, KL06931, KL06932, KL06933, KL06934, KL06937, KL06938, KL06939, KL06940, KL06941, KL06943, KL06944, KL06945, KL06946, KL06947, KL06948, KL06949, KL06950, KL06951, KL06952, KL06954, KL06955, KL06956, KL06958, KL06959, KL06960, KL06962, KL06963, KL06964, KL06965, KL06966,
KL06967, KL06968, KL06969, KL06970, KL06971, KL06980, KL06981, KL06982, KL06983, KL06984, KL06985, KL06986, KL06988, KL06989, KL06990, KL06991, KL06993, KL07043, KL07046, KL07048, KL07049, KL07050, KL07051, KL07052, KL07053, KL07054, KL07055, KL07056, KL07057, KL07058, KL07059, KL07060, KL07061, KL07062, KL07063, KL07064, KL07065, KM06215, KM06216, KM06217, KM06218, KM06219,
KM06220, KM06221, KM06222, KM06223, KM06224, KM06225, KM06226, KM06228, KM06229, KM06230, KM06231, KM06232, KM06233, KM06234, KM06235, KM06236, KM06237, KM06239, KM06240, KM06241, KM06242, KM06243, KM06244, KM06245, KM06246, KM06247, KM06248, KM06251, KM06252, KM06254, KM06255, KM06256, KM06257, KM06258, KM06259, KM06260, KM06261, KM06262, KS66762, KS66763, KS66764, KS66765,KS66766, KS66768, KS66770, and KS66771
c) Unit numbers FL04558, FL04561, FL04562, FT03896, FT03914, FT03919, FT03921, FT03924, FV01073, GL09850,GL09851, GL09852, GL09856, GL09860, GL09863, KJ52665, KJ52666, KJ52667, KJ52668, KJ52671, KJ52672, KJ52673, KJ52674, KJ52676, KJ52679, KJ52680, KJ52681, KJ52682,
KJ52683, KJ52684, KJ52685, KJ52686, KJ52687, KJ52758, KJ52760, KL06919, KL06920, KL06922, KL06925, KL06927, KL06929, KL06930, KL06932, KL06934, KL06937, KL06938, KL06939, KL06940, KL06944, KL06945, KL06946, KL06947, KL06950, KL06951, KL06952, KL06954, KL06955, KL06956, KL06959, KL06963, KL06964, KL06969, KL06970, KL06980, KL06984, KL07048, KL07049, KL07050, KL07054, KL07056,
KL07057, KL07058, KL07062, KL07063, KL07064, KL07065, KM06216, KM06217, KM06218, KM06219, KM06221, KM06222, KM06223, KM06224, KM06225, KM06226, KM06230, KM06231, KM06232, KM06235, KM06236, KM06239, KM06240, KM06241, KM06244, KM06245, KM06246, KM06247, KM06248, KM06251, KM06254, KM06256, KM06257, KM06260, KM06261, and KM06262.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 357 units;
b) 332 units;
c) 106 units.
DISTRIBUTION PA, and OH.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Unit numbers LC09637, LC08204, LC06028, LC03305, LC02438, LC01729, FS55247, FS52998, FS49013, FS45522, and FS42202;
b) Unit numbers LC06028, LC02438, and FS45522;
c) Unit numbers LC09637, LC08204, LC03305, LC01729, FS55247, FS52998, FS49013, and FS42202.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 11 units;
b) 3 units;
c) 8 units.
DISTRIBUTION VA, D.C., and NJ.

PRODUCT Product: Source Plasma.
CODE Unit 00EWIC7005.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P. (Formerly Community Bio-Services), Eau Claire, WI.

REASON Blood Product, collected from a donor whose health history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 41FW34387.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL.

WEEK ENDING NOVEMBER 8

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit 13FN86981.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products, collected from a donor taking the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Units 13P90716 (2 units), 13P90864, 13P90678, 13P90735, 13P90920 (2 units), 13P90021 (2 units), 13P90243 (2 units), 13P90318 (2 units), 13P90324 (2 units), 13P90358 (2 units), 13P90773 (2 units).
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products, collected during a period of apheresis machine validation, but were not properly quality control tested, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 0138113.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor whose medical history screening was not complete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Units D133050, E152877, E153128, F139550.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center & Program, Seattle, WA.
REASON Blood products, with incomplete compatibility testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION WA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) and d) Unit number 53H68507;
b) and c) Unit number 53FM55608.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MD, and CA.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Unit numbers 53M88168, 53M85906, and 53FM34305;
b) Unit number 53FM34305;
c) Unit number 53M88168.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MD, VA, D.C., and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units 32GE50021, 32KC26802, 32GE45669 and 32GE43957;
b) Units 32KC26802, and 32GE45669;
c) Units 32GE50021, and 32GE43957.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Badger-Hawkeye Region, Madison, WI.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION IL, WI, CA, and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Unit numbers 8091084, 6411519, 6621471;
b) and c) Unit number 6621471;
d) Unit numbers 8091084 and 6411519.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL, and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 9829088.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL.
REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 53L41074.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION D.C. and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 8469416.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL.
REASON Blood product, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 17KX90143.
RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region St. Paul, MN.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MN and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 21KC50605.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
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 OR.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 21KH73656.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
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 KA.

PRODUCT Red Blood Cells.
CODE Unit number 0804119.
RECALLING FIRM/MANUFACTURER LifeShare, Inc, Elyria, OH.
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 OH.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number P0967901.
RECALLING FIRM/MANUFACTURER South Bend Medical Foundation, Inc., South Bend, IN.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Recovered Plasma.
CODE Unit number 3428912.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL.
REASON Blood product, that tested negative for viral markers, but was collected from a donor that had been previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Scotland.

PRODUCT Source Plasma.
CODE Unit numbers G-68373-160, G-67245-160, G-66795-160, G-55196-160, G-54832-160, G-71773-160, G-71718-160, and G-57142-160.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Gainesville, FL.
REASON Blood product tested negative for viral markers but was collected from an ineligible donor due to risk factors for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION CA, and Switzerland.

PRODUCT Cryoprecipitated AHF.
CODE Unit number 8424272.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SC.

PRODUCT Fresh Frozen Plasma.
CODE Unit number M0842285.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 13GV02586, 13LG77668, 13GM72244;
b) Units 13LG77668, 13GM72244.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Units 0590271028, 0590270883, 0590270628, 0590270528, 0590270375, 0590270770, 0590270218, 0590270096, 0590269876, 0590269656, 0590268510, 0590268348, 0590268230, 0590268096, 0590267966, 0590267799, 0590267709, 0590267382.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Services, Inc., Allentown, PA.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit FC000919.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ.
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 previously tested repeatedly reactive for anti-HTLV-I/II with an indeterminate confirmation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 17KW44408.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Paul, MN.
REASON Blood products, which were collected from a donor who was taking the medication amantadine for the treatment of Parkinson's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA, and MA.

PRODUCT Fresh Frozen Plasma.
CODE Units 53H93038, 53L45988.
RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD.
REASON Blood products, in which the corresponding blood components were contaminated with Pseudomonas and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and D.C.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 32KR05894.
RECALLING FIRM/MANUFACTURER American Red Cross, 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 IL.

PRODUCT Osteochondral grafts Tissues.
CODE Tissue numbers 1740573, 1740575, 1740574.
RECALLING FIRM/MANUFACTURER Regeneration Technologies, Inc., Alachua, FL.
REASON Human tissues, collected from a donor who had engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 tissues.
DISTRIBUTION GA, NJ, and IL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE a), b), and c) Unit 17GZ23966.
RECALLING FIRM/MANUFACTURER American National Red Cross, North Central Region, St. Paul, MN.
REASON Blood products, collected from a donor who was taking the medication Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MN.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 2861319.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Red Cells, collected from a donor who had no hemoglobin check performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Units 77N246, 77N333, 77N433, 770016, 770102, 770316, 878382, 88A867, 88A987, 88B054, 8GS774, 8GS901.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TX.
Manufacturer: Aventis Bio-Services, Inc., Minneapolis, MN.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION IL, and Germany.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 17KL70449, 17FH82660.
RECALLING FIRM/MANUFACTURER American National Red Cross, North Central Region, St. Paul, MN.
REASON Blood products, incorrectly tested for the Kell antigen, and labeled Kell negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MN.

PRODUCT Source Plasma.
CODE Unit 70531589.
RECALLING FIRM/MANUFACTURER NABI Biopharmaceuticals, Scranton, PA.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b) and C) Unit 5454162.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit KS15425.
RECALLING FIRM/MANUFACTURER Inova Health System, Blood Donor Services, Annandale, VA.
REASON Blood Product, collected from a donor who had Crohn's Disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets, Pheresis, Leukocytes Reduced.
d) Fresh Frozen Plasma.
e) Cryoprecipitated AHF.
CODE
a) Units 803979, 8157697;
b) Units 8387398, 8395390, 8320642, 8235946;
c) Units (8456267, 8456224, 8391228, 8418723, 8418631 (A & B), 8093979;
d) Unit 8157697;
e) Units 8387398, 8320642, 8235946, 8395390.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, Florida.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION FL, NY, and Hawaii.

PRODUCT Fresh Frozen Plasma. .
CODE Unit 6145549.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, in which the corresponding blood component may have been contaminated with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Fresh Frozen Plasma.
CODE Units 6160934, 6160940.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, in which the corresponding blood component was contaminated with Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Human Tissue.
CODE Unit CryoVein, Saphenous Vein; Model # V010, Serial # 8049220.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Human tissue for transplantation, associated with a tissue in which the pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 9490445, 8484941, 8484959, 8490542, 8490408, 8484965, 8481828, 8484823, 8490448, 8484963, 8490464.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL.
REASON Red Cells, collected from donors whose hematocrits were not properly determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION FL and SC.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 1534130
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Jacksonville, FL.
REASON Platelets, contaminated with coagulase negative Staphylocoocus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit T80527.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Red Cells, that did not meet volume requirements for quality control, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells.
CODE Units 0567468, 6011834.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, collected from a donor who was taking the medication, Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD, and DE.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a), and b) Units 94-63397.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, collected from an ineligible donor due to the use of the medication Permax, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN, and CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.

CODE Unit number V10448.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
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 PA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.

CODE
a) Unit numbers 9232781, 9240761, and 9282808;
b) Unit number 9232781.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, that tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible donor due to previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION DE, MD, and VA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.

c) Platelets.
d) Cryoprecipitated AHF.
e) Recovered Plasma.
CODE
a) and c) Unit number 2012119;
b) and d) Unit numbers 2071963 and 0501304;
e) Unit numbers 2012119, 2071963,and 0501304.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION DE, and NJ.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE
a) Units L87489, L88457, L89419, L90475, L92380, R22276;
b) Units L88457, L89419;
c) Units L87489, L88457, L89419, L90475, L92380.
RECALLING FIRM/MANUFACTURER South Bend Medical Foundation, South Bend, IN.
REASON Blood products, collected from donors who were not properly reentered, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION IN.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit 5207689.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Jacksonville, FL.
REASON Blood products, collected from a donor who was taking the medication Antabuse, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Units 8380950A, 8380950B, 8390618A, 8390618B, 8453361A, 8453361B, 8385535A, 8385535B, 8385535C, 8494527A, 8494527B, 8476679A, 8475579B.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL.
REASON Blood products, collected from a donor who was taking the medication Plavix, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION NY, FL, SC, AL, and D.C.

PRODUCT Source Plasma.
CODE Units 57529370, 57530154, 58078797, 61414761, 61418288, 61420014, 59806752, 59807933, 59810056, 60190963, 60193308, 60196750, 60198112, 60199584, 61861305.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Muskogee, Oklahoma.
REASON Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit G-75013-026.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tuscaloosa, AL.
REASON Blood product, that tested negative for antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit N-88349-022.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., DBA Seramed Bio Center, Lake Charles, LA.
REASON Source Plasma, with an elevated ALT level, was distributed for further manufacture.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit 776082.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., DBA Seramed Bio Center, Baton Rouge, LA.
REASON Blood product, collected from an ineligible donor, was distributed for further manufacture.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) 49LJ51499.
RECALLING FIRM/MANUFACTURER Recalling Firm: American National Red Cross, Southwest Region, Tulsa, OK.
Manufacturer: American Red Cross Blood Services, Southwest Region, College Station, TX.
REASON Blood products, which were not quarantined after receiving information concerning post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK and Switzerland.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit 13GE11683.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 13FV01370.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products, collected from an ineligible donor due to the use of the medication Megace, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE GCHYZZ, GCHYWP, GCHXSV.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Indianapolis, IN.
REASON Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit 00EWIG3310.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P. (formerly Community Bio-Services) Eau Claire, WI.

REASON Blood Product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number F86519.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 16KJ06024, 16KJ06033, 16LG49556, 16GM24171, 16GM24229, 16KJ06002, and 16LL67719.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION MD.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 30773-6721.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fargo, ND.
REASON Red Blood Cells, that failed RBC recovery ratio, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Recovered Plasma.
CODE Unit 17KW44408.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Paul, MN.
REASON Blood products, which were collected from a donor who was taking the medication amantadine for the treatment of Parkinson's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA, and MA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
e) Source Leukocytes.
f) Recovered Plasma.
CODE
a) Units 8007711, 7888797, 7949974, 7980710, 7927676, 7840881;
b) Units 8185452, 8284550, 8249731, 8376390, 8052558, 8036477, 8115659, 8175917, 8351319;
c) Units 8284550, 8185452, 8351319, 8052558, 8036477, 8376390, 8249731;
d) Units 8287550, 8007711, 7980710, 8153249, 8115659, 7949974, 7888797, 8185452, 8052555;
e) Unit 7840881;
f) Unit 7867323.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL.
REASON Blood products, collected from a donor who had von Willebrand's Disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION FL, CA, OH, NY, MA, MD, and D.C.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units F67307, F67298.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL.
REASON Blood products, that lacked assurance of proper temperature storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Recovered Plasma.
CODE Unit 94-63397.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, collected from an ineligible donor due to the use of the medication Permax, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN, and CA.

PRODUCT Source Plasma.
CODE Unit numbers XG0016663 and XG0018791.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX.
REASON Blood products, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.

PRODUCT Source Plasma.
CODE Unit number CNG007147.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.
REASON Blood products, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 3700491.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Units 084C29330, 084M16756 (parts 1 & 2), 084M12262.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern California Region, Oakland, CA.
REASON Blood products, manufactured in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit F08620143.
RECALLING FIRM/MANUFACTURER Tri-Cities Plasma Corporation, Johnson City, TN.
REASON Blood product, which tested negative for viral markers, but was collected from a donor whose health history was inadequately determined.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit F02063143.
RECALLING FIRM/MANUFACTURER Tri-Cities Plasma Corporation, Johnson City, TN.
REASON Blood product, which tested negative for viral markers, but was collected from a donor whose health history was inadequately determined.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE CJBRBQ, CJBRBY, CJBQZF, CJCDZV, CJBQTQ, CJBQRV, CJDBQX, CJCDXY, CJFBQN, CJBQDL, CJBQDS, CJCDTV, CJDBBM, CJDBBN, CJCDTG, CJCZXZ, CJCZTY, CJCDPZ, CJBPJJ, CJCZGF, CJBYHP, CJCZGB, CJBPJQ.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., East Lansing, MI.
REASON Source Plasma, collected from a donor who did not answer all of the donor history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION IL.

WEEK ENDING NOVEMBER 15

PRODUCT Source Plasma.
CODE Units G76921160, G77197160, G79879160, G82492160, G82852160, G83232160, G83504160, G85222160, G86682160, and G87074160.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Gainesville, FL.
REASON Blood product, which was collected from a donor who had received a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION NC.

PRODUCT Platelets.
CODE Unit K35025.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI.
REASON Blood product, which was not tested for CMV, but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Unit 6707979.
RECALLING FIRM/MANUFACTURER Lifeshare, Inc., Elyria, OH.
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
CODE
a), c), and d) Unit 1923283;
b), and d) Unit 5612270.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood products, which were collected from a donor who was at risk for Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION FL, GA, and HI.

PRODUCT Red Blood Cells.
CODE Unit C26697.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA, and NJ.

PRODUCT Platelets Pheresis.
CODE Unit numbers P1018364A and P1018364B.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ.
REASON Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Platelets.
CODE Unit number M0842247.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ.
REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HIV), but was collected from an ineligible donor based on a previous positive test for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number M0837444.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ.
REASON Blood products, that tested negative for the human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Human Tissue for Transplantation, Corneas.

CODE Tissue numbers 03-0145 OD and 03-0145 OS.
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA.
REASON Human tissue for transplantation, that tested negative for viral markers, but was procured from a donor that participated in behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION WA, and Japan.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Cryoprecipitated AHF.
d) Fresh Frozen Plasma.
e) Recovered Plasma.
CODE
a), c), and e) Unit number 49LH44383;
b), and d) Unit numbers 49LH46086 and 49LF49471.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Waco, TX.
REASON Blood products, collected from an unsuitable donor based on use of an experimental medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION TX and Switzerland.

PRODUCT Red Blood Cells.
CODE Units numbers 8015606, 7023927, and 8015912.
RECALLING FIRM/MANUFACTURER Wellmont Health System, Kingsport, TN.
REASON Blood products, that tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TN and VA.

PRODUCT Platelets.
CODE Unit numbers 8015881, 8015880, 8015877, 8015879, 8015876, and 8015874.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION FL.

PRODUCT Platelets.
CODE Unit numbers 8016092, 8016096, and 8016095.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, LeukocytesReduced Irradiated.
CODE Unit number 9560800 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis.
CODE Unit number 9575551 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Platelets.
CODE Unit number 9559825.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL
REASON Blood product, that tested reactive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets.
CODE Unit number 9421376.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood product, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Red Blood Cells.
CODE Unit number 4190641.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit number 4194318.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) Unit numbers 4182545, 4188080, and 2912856.
b) Unit number 4182545.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION FL.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers 2003-05-2013 and 2003-05-2014.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO.
Manufacturer: Heartland Lions Eye Banks - Illinois Branch, Springfield, IL.
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION CT, and TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 84J54234.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA.
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 CA.

PRODUCT Source Plasma.
CODE Unit numbers 0590269936 and 0590270024.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Allentown, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers 0590268570, 0590268759, 0590268871, 0590269122, 0590269331, 0590269577, 0590269690, 0590269858, 0590269975, 0590270199, 0590270421, 0590270922, and 0590271007.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Allentown, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers FXTCBG, FXTBYL, FXTBTN, FXTBQP, FXTBHG, FXTBCV, FXSZYL, FXSZXF, FXSZTZ, FXSZTF, FXQQLV, FXQPMX, FXQNQC, FXQMSR, FXQLZC, FXQLBP, FXMVDK, FXPMGY, FXPKLJ, FXPJNY, FXPHHD, FXPGNG, FXPFMD, FXPDTD, FXMSZH, FXMSXM, FXPBLX, FXNZVX, FXMSNR, FXNYXT, FXMSJH, FXMSGG, FXMSBR, FXMBKB, FXMBFG, FXMBCB, FXLZXN, FXLZWC, FXLZRW, FXLZQL, FXLLRY, FXLLCX, FXLJVS, FXDYXC, BRZVVS, FXBCFB, FXBBZM, FXBBWL, FXBBSJ, FXBBNN, BRZPMC, BRZPDW, BRZMVF, BRZMKK, BRZKXY, BRZKPF, BRZHZZ, and BRZHPT.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 58 units.
DISTRIBUTION IL, Germany, and Italy.

PRODUCT Whole Blood.
CODE Units 21R66000, 21R69719, 21R70465, 21FR11923, and 21R69784.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Portland, OR.
REASON Blood product, which was labeled with an incorrect volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OR, and WA.

PRODUCT Source Plasma.

CODE Unit number G-78807-026.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tuscaloosa, AL.
REASON Blood product, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 6484134 (distributed as two split products).
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX.
REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number LE44687.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE a) and b) Unit number FM68763.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
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 MA and RI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers LE39919 and LE27908.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
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 MA.

PRODUCT
a) Red Blood Cells.
b) Platelets.

CODE
a) Unit numbers FC2001420 and FC2004365;
b) Unit number FC2001420.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NJ.

PRODUCT Human Corneas Tissues.
CODE Tissue numbers 2003-08-2023 and 2003-08-2024.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO.
Manufacturer: Heartland Lions Eye Banks - Illinois Branch, Springfield, IL.
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION KS, and MO.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 16GM28953.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH.
REASON Blood product, incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Platelets.
b) Platelets, Irradiated.
c) Platelets, Leukocytes Reduced
d) Fresh Frozen Plasma.
e) Plasma, Frozen within 24 Hours.

CODE
a) 001E39064, 001E47143, 001E51108, 001FC07937, 001FF36217, 001FF37100, 001FF38545, 001FF38839, 001FF39924, 001FF41099, 001FW04484, 001FW04550, 001FW04905, 001FW09051, 001FW09863, 001FW10028, 001GC28693, 001GC49072, 001GJ37006, 001GJ42638, 001GL39726, 001GL43091, 001GL50113, 001GL53398, 001GL61247, 001GN38524, 001GN41998, 001GY32342, 001GY37305, 001GY43608, 001GY43609, 01GY44147,
001GY44477, 001GY48591, 001GY49687, 001GY50873, 001GY51177, 001GY52859, 001GY52866, 001GY59939, 001GY63709, 001GY63928, 1KF42950, 001KF45334, 001KF45525, 001KF52363, 001KF54414, 001KF54620, 001KF55524, 001KF55793, 001KF55971, 001KF56065, 001KF56298, 1KF56676, 001KF60385, 001KF70497, 001KH30159, 001KH31694, 001KH36292, 001KH45219, 001KH45554, 001KH45556, 001KH45710, 001KH46144,
001KH46536, 001KH47164, 001KH47511, 001KH47829, 001KH47949, 001KH48063, 001KH48114, 001KH48132, 001KH48524, 001KH50613, 001KH51002, 001KH51364, 001KH52387, 001KH56072, 001KJ30535, 001KJ31401, 001KJ32494, 001KJ35056, 001KJ36220, 001KJ36873,
001KJ38776, 001KJ39013, 001KJ40161, 001KJ40765, 001KJ42214, 001KJ42828, 001KJ45068, 001KK50357, 001KK54217, 001KK58753, 01KK59625, 001KK61561, 001KK62868, 001KK64602, 001KK65199, 001KK65422, 001KK65746, 001KK66370, 001KK66401, 001KK66504, 001KK66800, 001KK66826, 001KK67140, 001KK67152, 001KK67175, 001KK67200, 001KK67841, 001KK67883, 001KK67884, 001KK68159, 001KK69014, 001KK70230, 001KK70530, 001KK70878, 001KK71399, 001KK71445, 001KK73687, 001KK75705, 001KT39618, 001KT51449, 001KT52428, 001KT53852, 001KT55373, 001KT56803, 001KT57003, 001KT57100, 001KT58048, 001KT58204, 001KT58956, 001KT59200, 001KT59735, 001KT60094, 001KX40897, 001KX47337, 001KX48516, 001KX49494, 001KX52292, 001KX53246, 001KX53829, 001KX55218, 001KX55252, 001KX55412, 001KX55468, 001KX55705, 001KX55762, 001KX55923, 001KX56351, 001KX56383, 001KX56420, 001KX57719, 001KX57942, 001KX64350, 001KX64706, 001KX65125, 001KY13906, 001KY14917, 001KY19520, 001LC31431, 001LC32523, 001LC32806, 001LC35361, 001LC35861, 001LE23513, 001LE25506, 001LE27003, 001LE27182, 001LH39428, 001LN16559, 001LN22600, 001LN22993, 001LN28866, 001LP30014,
001LP37998, 001LS27681, 001LS28653, 001LS32975, 001LT25078, 001LT25492, 001LV41608, 001LV42374, 001LW19499, 001LW22480, 001LW22747, 001LW23390, 001LW23447, 001LW25082, 001Q41288, 001Q41964, 001Q41971, 001Q42317, 001Q42457, 001Q42468, 001Q43467, 001Q43685, 001Q44662, 001Q46859, 001Q48143, 001Q48363, 001Q48440, 001Q48441, 001Q48481, 001Q48637, 001Q48882, 001Q49016,
001Q49459, 001Q49543, 001Q50067, 001Q50585, 001Q54407, 001W79733, 001W79796, 001W82240, 001W83685, 001W83909, 001W84973, 001W85223, 001W85365, 001W85615, 001W85669, 001W85844, 001W86073, 001W86387, 001W86680, 001W86765, 001W89792, 001W91754, 001Y31072, 001Y34226, 001Y35745, 001Y35770 , 001Y36563, 001Y36803, 001Y39044, 01FW12575, 01FW13087, 01GN59581, 01KH59836, 01KH60374, 01KH63741, 01KH65066, 01KJ49404, 01KK77332, 01KK79160, 01KK79829, 01KM14706, 01KM15667, 01KX70726, 01KX71952,
01LE27383, 01LT35513, 01LT41087, 01LV48868, 01LW28635, 01LY18827, 01Q59726, 01Q59738, 01W00103, 01W00681, 01Y41220, 01Y41233,
01Y41556, 01Y42697, 01Y45655, 01Y46543;
b) Units 001E46341, 001FC05136, 001FF32765, 001FF38791, 001GY33613, 001KF44812, 001KF50715, 001KH31689, 001KH39704, 001KK66971, 001Q48352, 001Q55419, 001W93012, 001Y26561, 01Y41440;
c) Unit 001KF49427;
d) Units 01E51108, 001FC05136, 001FF36217, 001FF38545, 001FF38791, 001FF41099, 001FW04550, 001FW09863, 001FW10028, 001GJ42638, 001GL50113, 001GY44240, 001GY45232, 001GY49687, 001GY50873, 001GY51177, 001GY52859, 001GY52866, 001GY59939, 001KF45334,
001KF54620, 001KF55524, 001KF55793, 001KF55976, 001KF56946, 001KF60385, 001KH31521, 001KH31689, 001KH39704, 001KH45219, 001KH45554, 001KH45556, 001KH45710, 001KH46144, 001KH46250, 001KH46536, 001KH47164, 001KH47663, 001KH47829, 001KH48114,
001KH48132, 001KH48524, 001KH51002, 001KH56072, 001KJ31401, 001KJ34897, 001KJ35041, 001KJ35051, 001KJ39670, 001KJ39943, 001KJ40161, 001KJ40714, 001KJ40765, 001KJ42198, 001KJ42828, 001KJ45068, 001KK64397, 001KK65746, 001KK66370, 001KK66408,
001KK66504, 001KK66826, 001KK66971, 001KK67152, 001KK67200, 001KK67841, 001KK67883, 001KK67884, 001KK67893, 001KK68159, 001KK70252, 001KK70530, 001KK71399, 001KK71445, 001KT48199, 001KT55373, 001KT58204, 001KT59735, 001KX53729, 001KX53829,
001KX55252, 001KX55705, 001KX55725, 001KX55762, 001KX57942, 001KY19520, 001LC28753, 001LC32806, 001LC35361, 001LC35861, 001LE22560, 001LE25506, 001LH39428, 001LP37998, 001LS27681, 001LS28653, 001LS32975, 001LV41608, 001LV42374, 001LW22480,
001LW25082, 001Q45630, 001Q48334, 001Q48481, 001Q48882, 001Q49016, 001Q49543, 001Q50585, 001Q54407, 001W74640, 001W75332, 001W82240, 001W83685, 001W83828, 001W83909, 001W84178, 001W84592, 001W84891, 001W84897, 001W85223, 001W85365, 001W85615, 001W85669, 001W85844, 001W86765, 001W90908, 001W91754, 001Y34226, 001Y36089, 001Y36480, 001Y36563, 001Y40054;
e) Units 001GG58310, 001GY63709, 001KF70497, 001KX64350, 001KX65125, 001LE27003, 001LE27182, 001LN26296, 001LN28866, 001W93012, 01FW13087, 01GN57109, 01GN59579, 01GN59581, 01KH59836, 01KH59891, 01KH63741, 01KH64318, 01KH65066, 01KJ49404, 01KJ51104, 01KK77929, 01KK78820, 01KX70559, 01KX70726, 01KX71784, 01KX71952, 01KX71959, 01LH51291, 01LS40072, 01LT35513, 01LT41087, 01LV48868, 01LW26719, 01LW28635, 01Q56811, 01Q60630, 01Q60704, 01W00078, 01W00103, 01W00681, 01Y41556, 01Y42697, 01Y45655.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY.
REASON Blood products, corresponding to units of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 269 units;
b) 15 units;
c) 1 unit;
d) 132 units;
e) 44 units.
DISTRIBUTION NY, PA, and MA.

PRODUCT
a) Red Blood Cells.

b) Platelets.
Fresh Frozen Plasma.
CODE a), b), and c) Unit M16959.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 6622677.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, TN.
REASON Blood product, collected from a donor who visited a malarial endemic region, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Unit numbers 0181083739, 0181084704, 0181084963, 0181085355, 0181086373, 0181086639, 0181087018, 0181087260, 0181087560, 0181087677, 0181088254, 0181088514, 0181088761, 0181089069, 0181089433, and 0181088020.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers 0181089405, 0181088890, 0181088668, 0181088367, 0181088196, 0181087847, 0181087661, 0181087106, 0181086905, 0181086203, 0181085956, 0181085588, 0181085240, and 0181084550.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 042KW17622.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, that was labeled leukoreduced but was not tested for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Source Plasma.
CODE Units 0078567, 0078893, 0079136, 0079405, 0079667, 0080436, 0080922, 0081128, 0081302, 0081450, 0081632, 0081799, 0081942, 0082275, 0082390, 0082763, 008310, 0083087, 0083381, 0083540, 0083859, 0084019, and 0084524.
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, LLC, Carbondale, IL.
REASON Blood product, that was collected from a donor who had undergone surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION NY and NC.

PRODUCT Source Plasma.
CODE Units G27321160 and G26939160.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Gainesville, FL.
REASON Blood product, which was collected from a donor who had undergone surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Switzerland.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Irradiated.
c) Platelets Pheresis Leukocytes Reduced.
CODE
a) Units 0165693, 0165728, 016529, 0165731, 016539, 0165745, 0165747, 0165749, 0165750, 0165828, 0165831, and 0165834;
b) Unit 0165693;
c) Units 0165722, 0165724A, 0165724B, and 0165912.
RECALLING FIRM/MANUFACTURER Marquette General Hospital, Inc., Marquette, MI.
REASON Blood products, which were incorrectly tested for infectious diseases, but subsequently were re-test and found negative for infectious diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Unit J44291.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI.
REASON Blood product, which was collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Units 9284453, 9284454, 9284455, 9284456, and 9284457.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood product, which was shipped at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION DE, MD, and TX.

PRODUCT Recovered Plasma.
CODE Unit C26697.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA, and NJ.

PRODUCT Red Blood Cells.
CODE Unit number 9673486.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Whole Blood.
CODE Unit number 9560492.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit numbers 8016092, 8016094, and 8016097.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL.
REASON Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 5340205.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
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 FL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
d) Plasma.
e) Red Blood Cells, for further manufacture into non-injectable products.
f) Red Blood Cells, for further manufacture.
g) Recovered Plasma.
CODE
a) Unit numbers 042K58582, 042R67007, 042K58077, 042FG00479, 042FG00484, 042FW08604, 042FW08605, 042S95164, 042T16011, 042Y34246, 042FE78536, 042FS78802, 042FY41828, 042K58085, 042Q78671, 042T16014, 042T17021, 042X69807, 042FG00443, 042Y35350, 042FG00474, 042R67008, 042FS78801, 042FG00206, 042FG00324, 042FG00442, 042FG00446, 042FG00448, 042FG00483, 042FM35981, 042FS78800, 042FT31291, 042FT31294, 042FT31335, 042FT31337, 042FW08615, 042FX21670, 042FX21980, 042FY41830, 042G41864, 042G41870, 042G41874, 042G41876, 042G41884, 042J46570, 042J46571, 042J46577, 042J46582, 042J46586, 042K58083, 042L14424, 042L14426, 042Q78661, 042Q78662, 042Q78665, 042Q78666, 042Q78674, 042Q78764, 042Q78765, 042Q78669, 042R67830, 042R67833, 042R67834, 042S95179, 042T16029, 042T16031, 042T17016, 042T17018, 042T17019, 042T17024, 042T17049, 042T17053, 042T17067, 042X70027, 042X70933, 042X70943, 042Y35956, 042Y35962, 042Y35965, 042S95172, 042FE78542, 042FM35983, 042FY41805, 042T17014, 042T17022, 042X69963, 042Y35335, 042FG00475, 042FS78816, 042G41878, 042K58591, 042Q78749, 042FW08608, 042FW08614, 042FX21675, 042K58601, 042Q78663, 042Y34240, 042Y34242, 042Y34248, 042Y34256, 042K58064, 042FG99793, 042FG99814, 042FS78803, 042FY41792, 042G41881, 042K58585, 042T17052, 042Y35332, 042Y35364, 042T17059, 042X70099, 042Y35344, 042FE78550, 042J46584, 042T17041, 042T17050, 042X70925, 042Y36206, 042FY41826, 042K58612, 042X71409, 042Y36189, 042FG00320, 042L14423, 042Y34236, 042Y34218, 042Y34229, 042FG00204, 042FT31331, 042FT31330, 042FT31350, 042K58863, 042Q78761, 042Q78763, 042Y34227, 042FG00198, 042FG00462, 042FG00476, 042FS78814, 042FY41790, 042J46578, 042K58067, 042K58080, 042K58589, 042L14431, 042L14432, 042L14434, 042R67829, 042R67849, 042S95141, 042S95143, 042T17060, 042X70620, 042Y36182, 042FX21690, 042X70622, 042Y36201, 042Y35329, 042R67836, 042FT31343, 042Y34233, 042FG99801, 042J46588, 042FM35979, 042FT31353, 042FX21677, 042K58072, 042R67837, 042S95166, 042S95177, 042Y35958, 042T17066, 042FG99813, 042FM35991, 042FX21960, 042J46583, 042K58058, 042K58592, 042Q78668, 042Q78766, 042Q78768, 042T16016, 042T16044, 042X70052, 042X70937, 042Y35346, 042Y36147, 042Y36177, 042Y36181, 042FT31341, 042FX21672, 042FX21673, 042X70953, 042X70963, 042FG00465, 042FG00466, 042FG00469, 042FS78808, 042Y36210, 042K58866, 042FX21687, 042Q78660, 042X70619, 042Y35322, 042Y35333, 042FE78537, 042FS78828, 042FT31324, 042L14435, 042Q78659, 042Q78672, 042Q78673, 042FE78540, 042FG00463, 042FG99792, 042FX21688, 042FX21971, 042FX22000, 042G41863, 042K58020, 042K58028, 042K58060, 042K58586, 042Q78675, 042R67846, 042R67848, 042S95140, 042T17056, 042T17064, 042X69977, 042X70926, 042X70947, 042X71398, 042X71419, 042Y35326, 042Y35338, 042Y35349, 042Y35963, 042FG00464, 042X69793, 042Y35363, 042FY41784, 042K58590, 042K58606, 042K58608, 042X70124, 042Y34253, 042Y36154, 042L14436, 042S95144, and 042S95175;
b) Unit numbers 042FT31341, 042FY41784, 042FY41805, 042J46570, 042J46582, 042K58064, 042Y34246, 042Y35322, 042Y35329, 042Y35333, 042Y35335, 042FM35991, 042FS78802, 042FW08608, 042FW08609, 042FW08614, 042FX21690, 042Y35346, 042K58072, 042R67848, 042FY41792, 042FE78536, 042FE78537, 042FE78540, 042FE78542, 042FE78550, 042FG00462, 042FG00463, 042FG00464, 042FG00465, 042FG00466, 042FG00469, 042FG00475, 042FG00476, 042FG00479, 042FG00483, 042FG00484, 042FG99792, 042FG99813, 042FG99814, 042FS78803, 042FS78808, 042FS78828,
042FT31294, 042FT31330, 042FT31337, 042FT31343, 042FT31350, 042FT31353, 042FX21687, 042FX21966, 042FX21971, 042K58067, 042K58077, 042K58080, 042K58083, 042K58085, 042K58582, 042K58585, 042K58586, 042K58589, 042K58590, 042K58591, 042K58592, 042K58601, 042K58606, 042K58608, 042K58612, 042K58863, 042L14431, 042L14432, 042L14436, 042S95141, 042S95144, 042S95165, 042S95172, 042S95175, 042S95177, 042S95179, 042T16029, 042T16031, 042T16044, 042T17014, 042T17016, 042T17019, 042T17021, 042T17022, 042T17024, 042T17049, 042T17050, 042X69793, 042X69807, 042X69963, 042X70027, 042X70099, 042X70926, 042X70947, 042X70963, 042X71354, 042X71358, 042X71372, 042X71393, 042X71397, 042X71398, 042X71407, 042X71409, 042X71410, 042Y34227, 042Y34229, 042Y34236, 042Y34242, 042Y34248, 042Y34253, 042Y34256, 042Y35344, 042Y35349, 042Y35363, 042Y35364, 042Y36177, 042Y36181, 042Y36182, 042Y36189, 042Y36201, 042Y36210, 042X70124, 042FT31324, 042FT31331, 042FY41795, 042FY41818, 042FY41820, 042X70052, 042Y35338, 042Y34218, 042T16014, 042Y35320, 042Y36154, 042FG99811, 042FS78827, 042T16011, 042X70933, 042T16016, 042Y35350, 042Y36147, 042FY41812, 042FY41815, 042S95136, 042X70026, 042Y36187, 042X71416, 042FY41790, 042FG99810, 042FT31323, 042FY41803, 042R67846, 042R67847, 042X70937, 042X71419, 042Y35326, 042Y35332,
042FG99801, 042FT31291, 042FY41797, 042X70925, and 042X70943;
c) Unit numbers 042FE78550, 042K58077, 042K58083, 042K58085, 042S95165, 042Y35320, 042Y35322, 042Y35332, 042Y35333, 042FE78540, 042FX21980, 042S95172, 042Y35344, 042FW08614, 042Y36154, 042FE78536, 042FE78542, 042FG00462, 042FG00464, 042FG99792, 042FG99793, 042FM35991, 042FW08609, 042S95136, 042S95177, 042X69977, 042Y34246, 042Y35364, 042Y36177, 042FG99801, 042K58028, 042Y35349, 042FE78537, 042J46570, 042J46571, 042X70026, 042X70027, 042FG99810, 042K58020, 042K58067, 042K58072, 042Y35326, 042Y35363,
042X70099, 042X69793, 042FM35983, 042K58080, 042S95141, 042X70052, 042FG99811, 042K58058, 042FG99813, 042Y36181, 042FG99814, 042FS78827, 042J46578, 042Y34227, 042Y34229, 042Y34256, 042FS78828, 042Y35329, 042Y35338, 042Y36147, 042FT31353, 042S95144, 042S95175, 042S95179, 042FS78808, 042K58612, 042S95140, 042Y35335, 042FT31350, 042X69807, 042X70124, 042Y34236, and 042Y34242;
d) Unit numbers 042G41863, 042Y35958, 042FX21690, and 042Q78671;
e) Unit numbers 042FS78805 and 042S95136;
f) Unit numbers 042FG99810, 042FG99811, 042FS78827, 042FW08609, 042FY41799, 042K58034, 042R67006, and 042Y36187;
g) Unit numbers 042FG00320, 042FS78799, 042FS78800, 042FS78801, 042FS78816, 042FW08605, 042FX21960, 042J46584, 042J46588, 042K58034, 042L14434, 042L14435, 042Q78761, 042T17018, 042T17067, 042X70620, 042X70953, 042Y35956, 042FG00198, 042FG00204, 042FG00206, 042FG00324, 042FG00441, 042FG00442, 042FG00443, 042FG00446, 042FG00448, 042FG00463, 042FG00465, 042FG00466, 042FG00469, 042FG00476, 042FG00479, 042FG00483, 042FG00484, 042FM35979, 042FM35981, 042FS78802, 042FS78803, 042FS78805, 042FT31291, 042FT31323, 042FT31324, 042FT31330, 042FT31331, 042FT31335, 042FT31337, 042FT31341, 042FT31343, 042FW08604, 042FW08608, 042FW08615, 042FX21670, 042FX21672, 042FX21673, 042FX21675, 042FX21677, 042FX21687, 042FX22000, 042FY41784, 042FY41790, 042FY41792, 42FY41805,
042FY41812, 042FY41815, 042FY41817, 042FY41818, 042FY41820, 042FY41828, 042FY41830, 042G41864, 042G41870, 042G41874, 042G41876, 042G41878, 042G41881, 042G41884, 042J46577, 042J46582, 042J46583, 042J46586, 042K58064, 042K58582, 042K58585, 042K58586, 042K58589, 042K58590, 042K58591, 042K58592, 042K58601, 042K58606, 042K58608, 042K58863, 042K58866, 042L14423, 042L14424, 042L14426, 042L14431, 042L14432, 042L14436, 042Q78659, 042Q78660, 042Q78661, 042Q78662, 042Q78663, 042Q78666, 042Q78668, 042Q78669, 042Q78672, 042Q78673, 042Q78674, 042Q78675, 042Q78749, 042Q78763, 042Q78764, 042Q78765, 042Q78766, 042Q78768, 042R67006, 042R67007, 042R67008, 042R67829, 042R67830, 042R67833, 042R67834, 042R67836, 042R67837, 042S95164, 042S95166, 042T16011, 042T16014, 042T16016, 042T16029, 042T16031, 042T16044, 042T17014, 042T17016, 042T17019, 042T17021, 042T17022, 042T17024, 042T17049, 042T17050, 042T17052, 042T17053, 042T17056, 042T17059, 042T17060, 042T17066, 042X70619, 042X70622, 042X70925, 042X70926, 042X70933, 042X70937, 042X70943, 042X70947, 042X70963, 042Y34218, 042Y34233, 042Y34248, 042Y34253, 042Y35346, 042Y35350, 042Y35962, 042Y35963, 042Y35965, 042Y36182, 042Y36187, 042Y36189, 042Y36201, 042Y36206, and 042Y36210.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood products, that were collected by an employee who was observed on at least one occasion to collect blood in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 253 units;
b) 164 units;
c) 76 units;
d) 4 units;
e) 2 units;
f) 8 units;
g) 173 units.
DISTRIBUTION Nationwide and Switzerland.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) Unit number 5651860;
b) Unit numbers 5651858, 5651859, 5651860, 5651861, 5651864, 5651867, 5651870, and 5651881.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood products, prepared more than eight hours after collection of the corresponding unit of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION FL, NY, and GA.

PRODUCT Red Blood Cells.
CODE Unit number 2452053.
RECALLING FIRM/MANUFACTURER Department of the Army, Frank R. Camp Memorial Blood Center, U.S. Army Medical Department Activity, Fort Knox, KY.
REASON Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT Source Plasma.
CODE Units CQVYZZ, CQVYRX, and CQVKBH.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Louisville, KY.
REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL and Germany.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Plasma.
CODE a), b) and c) Unit number 53FN85322.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MD and D.C.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma.
CODE
a) Unit numbers 53GE72112, 53GE72411, 53GE72412, 53L50195, 53C23125, 53FX89724, 53FX89731, 53FX89732, 53FH00827, 53FH00829, 53FH00830, 53C25707, 53C25708, 53FC21909, and 53G63413;
b) Unit numbers 53GE72070, 53GE72112, 53GE72411, 53GE72412, 53GF45253, 53FH00827, 53FH00830, 53L54836, 53Q99047, 53C25707, 53C25708, 53FC21909, and 53G63413.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 28 units.
DISTRIBUTION MD, PA, VA, and D.C.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 53F41535.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

WEEK ENDING NOVEMBER 22

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit 6707979.
RECALLING FIRM/MANUFACTURER Lifeshare, Inc., Elyria, OH.
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit number 53LL59082.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
e) Recovered Plasma.
CODE
a), c), and d) Unit number KT08214;
b), and e) Unit number KT04390.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION VA, and NJ.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number T99694.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 0891022.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Jackson, TN.
REASON Blood product, collected from a donor whose health history screening was inadequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Unit number VL116243.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Shreveport, LA.
REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers VL127096, VL126189, VL125789, VL125544, VL125204, VL124967, VL124518, VL124274, VL123804, VL123522, VL123149, VL122844, VL122215, VL121898, VL121453, VL121098, VL120771, VL120363, VL120240, VL119718, and VL119622.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Shreveport, LA.
REASON Blood products, that tested negative for syphilis, but were collected from an ineligible donor based on previous reactive testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells Leukoreduced.
b) Recovered Plasma.

CODE
a) Units: 3048919, 3048973, 3049029, 4061527;
b) Units: 3048919, 3048973, 3049029.
RECALLING FIRM/MANUFACTURER Community Blood Center, Inc., Appleton, WI.
REASON Blood products, collected from donors who had body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION MA, MI, WI, and FL.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit 21KP38884.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Pacific Northwest Region, Portland, OR.
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 OR.

PRODUCT Source Plasma.
CODE Unit 39865687, 39852366, 39845009, 39840738, 39820006, 39788030, 39779601, 39775535, 39767318, 39763594.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Medford, OR.
REASON Blood products, collected from an unsuitable donor based on a previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit 13898465, 13502010, 21653582, 21656033, 21658778, 23683488, 18973310, 18872286, 18878486, 25841893, 25844313, 25848465, 25849394, 25241518, 25247732, 25233889.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Gresham, OR.
REASON Blood products, collected from an unsuitable donor based on a previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.

CODE Unit numbers 0181085324, 0181084930, 0181084672, 0181084230, 0181084010, 0181083622, 0181083319, 0181083134, 0181082650, 0181082422, 0181082019, 0181081786, 0181081324, 0181081203, 0181088815, 0181080269, 0181080039, 0181079623, 0181079413, 0181076976, 0181077460, 0181078195, 0181078421, 0181078789, and 0181079008.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers 0181084171, 0181082913, 0181082849, 0181081884, 0181081620, 0181081269, 0181081050, 0181080350, 0181080111, 0181079658, 0181079434, 0181079025, 0181077174, 0181076421, 0181075845, 0181075755, 0181075235, 0181074914, 0181074566, 0181073793, 0181073655, and 0181072934.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers N-65845-139, N-65860-139, G-09540-139, G-09755-139, G-13082-139, G-13594-139, G-13745-139, G-14110-139, G-14446-139,

G-15176-139, G-16381-139, G-16887-139, G-17767-139, G-17893-139, G-18561-139, G-18883-139, G-19150-139, G-19531-139, G-20001-139,
G-20298-139, G-20697-139, G-21284-139, G-21586-139, G-21822-139, G-22784-139, G-23016-139, G-23452-139, G-25987-139, G-26046-139,

G-27536-139, G-27617-139, G-28014-139, G-28375-139, G-28629-139, G-29023-139, G-29380-139, G-29777-139, G-30038-139, G-30337-139,
G-30754-139, G-30923-139, G-31296-139, G-31515-139, G-32318-139, G-35520-139, G-35868-139, G-37675-139, G-37976-139, G-38203-139,

G-38898-139, G-39158-139, G-40544-139, G-40611-139, G-41198-139, G-41408-139, G-42356-139, G-42656-139, G-42900-139, G-43364-139,
G-49327-139, G-43505-139, G-43944-139, G-44537-139, G-44930-139, G-45218-139, G-45652-139, G-45884-139, G-46280-139, G-46518-139,

G-47268-139, G-47604-139, G-47956-139, G-48519-139, and G-49889-139.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Mobile, AL.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jacob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 74 units.
DISTRIBUTION CA, and Spain.

PRODUCT Red Blood Cells.
CODE Unit number 8088090.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
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 IL.

PRODUCT Source Plasma.
CODE Unit numbers 0181029519, 0181029288, 0181021630, and 0181018865.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 40GY00220 (distributed as two split units) and 40GY00219.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of American Region, Peoria, IL.
REASON Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.

PRODUCT VistA Blood Bank Software.
CODE Version number 5.2, software patch LR*5.2*301.
RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines, IL.
Manufacturer: Dallas Office of Information Field Office, Grand Prairie, TX.
REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 version.
DISTRIBUTION Nationwide.

PRODUCT Source Plasma.
CODE Units 54166084, 51456535, 51450793, 51409531, 51401870, 51379155, 51368005, 51364540, 51356071, 51350505.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Medford, OR.
REASON Blood products, which were collected from a donor who had received a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit 6066738.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN.
REASON Blood product, that was labeled as leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 13FV15457, 13FV15978, 13FP05903, 13FJ97099, 13GL13000, 13FY79490, 13GF00873, 13GW20027, 13GE06108, 13GE06107, 13GE06106, 13GF00912, 13GQ57560, 13GV33324, 13GV33323, 13FE22632, 13GV33322, 13GV33319, 13FE22631, 13GV33321, 13FY84034, 13GQ60446, 13GQ60476, 13GL12733, 13GL12732, 13GE06606, 13FM83902, 13FR50650, 13GM75083, 13FK10012, 13FK10011, 13GR37809, 13GQ58756, 13FQ14971, 13FH99483, 13FK09266, 13GX57002, 13FQ14721, 13FV13701, 13FK09682, 13FP04328, 13FQ15330, 13GQ57561, 13FE22633, 3FH98331, 13FE23543, 13FP04550, 13FP04540, 13FV15228, 13FN85642.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Red Blood Cells, prepared more than eight hours and thirty minutes from time of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 50 units.
DISTRIBUTION MI.

WEEK ENDING NOVEMBER 29

PRODUCT Platelets, Pheresis.
CODE Units 0883909A, 0883909B.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, TN.
REASON Blood products, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Units 46DCLKZGAB, 46DCKNQDAB, 46DCKNMGAB, 46DCKNLGAB, 46DCKNKHAB, 46DCKMZMAB, 46DCKMYMAB, 46DCKMXQAB, 46DCKMWSAB, 46DCKMTNAB, 46DCKMTDAB, 46DCKMPSAB, 46DCGSVPAB, 46DCGSTQAB, and 46DCGSTGAB.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc. Decatur, IL.
REASON Blood products, which were collected from a donor with a history of body piercing, were as distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION IL.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 9399264.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, which was collected from a donor who was deferred for receiving a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Unit number 38737084.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Corpus Christi, TX.
REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 22LV95821.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood product, corresponding to a blood product that was possibly contaminated with Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 13GV35969.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
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 MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 13FK14653.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
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 Units 53GC43434, 53GC43444, 53LL58237, 53LL58240, 53GQ97626, 53Q95102.
RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD.
REASON Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MD.