SEPTEMBER 2003

WEEK ENDING SEPTEMBER 6

PRODUCT Platelets.
CODE Unit 2866330.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor who had the oral typhoid immunization, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
d) Platelets.
e) Cryoprecipitated AHF.
CODE
a) Unit 1401448;
b) Units 1638433, 1697679;
c) Unit 1360055;
d) Unit 1638433;
e) Unit 1360055.
RECALLING FIRM/MANUFACTURER South Texas Blood & Tissue Center, San Antonio, TX.
REASON Blood products, collected from a donor who had received Human Chorionic Gonadatropin (HCG), were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION FL and TX.

PRODUCT Red Blood Cells, Deglyercolized.
CODE Unit 1855781.
RECALLING FIRM/MANUFACTURER South Texas Blood & Tissue Center, San Antonio, TX.
REASON Red Cells, which exceeded the firm's specifications for free hemoglobin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 04V99092.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 004M02161.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood product, collected from a donor with a history of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Source Plasma.
CODE Unit BFBKCY.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood product, collected in a manner that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells, Leucocytes Removed, Irradiated.
b) Platelets.
CODE a) and b) Unit 9063837.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Units 8003897A, 1267316A, 8001723A, 8001723B.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA.
REASON Platelets, with inadequate plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets, Leukoreduced, Irradiated.
c) Recovered Plasma.
CODE a), b), and c) Unit 1858633.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
REASON Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and FL.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE a) and b) Unit 2330487.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
REASON Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and FL.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit N36145.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Platelets.
CODE Unit N30268.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood products, collected from a donor taking the drug Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT

a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE a) and b) Unit N06278.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood products, collected from a donor taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN and NY.

PRODUCT Fresh Frozen Plasma.
CODE Unit 2913812.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood product, manufactured from an overweight Whole Blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 8003918A, 8003918B.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA.
REASON Platelets, which had a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 20P17647.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Boise, ID.
Manufacturer: American Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON Platelets, which were labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Platelets.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
d) Cryoprecipitated AHF.
CODE
a) Units 24GK13407, 24KQ26976, 24KQ26978, 24KJ44023, 24KL30738, 24KS27745, 24KY31103, 24KE29214, 4KY33832,
24KS34740, 24GZ10305, 24GL25817, 24KJ34429, 24KQ19933, 24KE22085, 24KG27452, 24KH34007, 24KM42179, 24KS25419, 24KH34392, 24KY25938, 24KG27554, 24KY26030, 24KG26589, 24KM47096, 24GQ24082, 24KE24358, 24KM48129, 24GQ25221, 24KK86791, 24KY30020, 24GY10853, 24KG29766, 24KY31075, 24KY31076, 24KE27597, 24KY31463, 24KL33842, 24KK92631, 24KJ49506, 24KY39209, 24GQ37865, 24GQ42475, 24GQ42579, 24GL25814, 24GJ49366, 24KH70077, 24KJ57494, 24KJ37014;
b) Units 24GQ52000, 24KH73191, 24KJ59638, 24GK25666, 24KL33103, 24KY51366, 24KL53937, 24FC02265, 4FC03714,
24KH76541, 24KQ47756, 24KH79761, 24KG49355, 24KH82735, 24GL29661, 24KH92226, 24KH71063;
c) Units 24KM35258, 24KQ27943, 24KF03555, 24KH46347, 24KY33049, 24KH46457, 24KK95086, 24KM72095, 24KH72519, 24KY51366, 24KH18011, 24KH19224, 24KG19956, 24KG21919, 24KF02308, 24KE22085, 24KS24784, 24KS25419, 24KG27452, 24KY25067, 24KH34007, 24KM42179, 24KH34392, 24KY25938, 24KG27554, 24KQ25150, 24KE23865, 24KM47096, 24KJ43570, 24KS26194, 24KM48129, 24KK86791, 24KJ44023, 24KL30738, 24KS27745, 24KS28563, 24KY31075, 24KY31076, 24KE27597, 24KY31103, 24KY31463, 24KM52449, 24KE29214, 24KE29463, 24KH42908, 24KL34756, 24KH61351, 24KH61493, 24KH67155, 24FC03714, 24KH72189, 24KJ59298, 24KH73191, 24KJ59638, 24KH76541, 24KL33103, 24KH76982, 24KL53235, 24KQ47756, 24KH79761, 24KG49355, 24KL56631, 24KH92226, 24KH82735, 24KJ35682, 24KQ19933, 24KH20767;
d) Units 24KL22612, 24FK02148, 24KJ57913, 24KM71032, 24KL52096, 24KC26307, 24KH75236, 24KJ60683, 4KX08815.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, River Valley Region, Louisville, KY.
REASON Blood products, corresponding to a unit of clotted Red Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 49 units;
b) 17 units;
c) 67 units;
d) 9 units.
DISTRIBUTION KY, IN, GA, PA, VA, AK, AL, NY and Puerto Rico.

PRODUCT Plasma.
CODE Unit 03FV82722.
RECALLING FIRM/MANUFACTURER American National Red Cross, Atlanta, GA.
REASON Blood product, corresponding to a unit of clotted Red Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 03F14795.
RECALLING FIRM/MANUFACTURER American National Red Cross, Atlanta, GA.
REASON Platelets, which contained aggregates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit 01FP24683 (part 2);
b) Unit 01FP24683 (part 1).
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY.
Manufacturer:American Red Cross Blood Services, Albany, NY. Firm initiated recall is complete.
REASON Blood products, tested using sample tubes that may have been diluted with saline, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Recovered Plasma.
CODE
a) Units 7923116, 3582022;
b) Unit 9553569;
c) Unit 7923116;
d) Units 7923116, 3582022, 9553569.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF.
d) Recovered Plasma.
CODE
a) Units 9822891, 9053018, 9052141;
b) Unit 9822891;
c) Units 9053018, 9052141;
d) Unit 9052141.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, collected from a donor with a history of having tested positive for hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 7 Units.
DISTRIBUTION WI. and IL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Units 2370458, 2365850.
RECALLING FIRM/MANUFACTURER LifeSource, 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 6 units.
DISTRIBUTION IL and WI.

PRODUCT Source Plasma.
CODE BFFSPH, BFFRBY, BFFNCX, BFFMNK, BFFKXS, BFFKJP,BFFJQM, BFFJDZ, BFFGXN.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION IL.

PRODUCT Source Plasma. .
CODE Units 7YK689, 7YK417, 7YK201, 7YJ182, 7YJ007.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION Il.

PRODUCT Source Plasma.
CODE Units BFFQML, BFFQKJ, BFFQFM, BFFPYC, BFFPPY, BFFPRH, BFFNYV, BFDBVJ, BFDBMV, BFDBKF, BFCXYW, BCXWZ, BFCWMJ, BFCWJZ, BFCVVV, BFBLNP, BFBLFX, BFBKQL, 98B140, 98B116, 435250, 435201, 435123, 435093.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood products, collected from a donor with a history of cocaine addiction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit BFGQCS.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
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 IN.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 0929865, 0930998, 0929168, 0930997, 0929864;
b) Unit 0947221.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood products, corresponding to Platelets that were implicated in a transfusion reaction and contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION OH and KY.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 0951054.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit T49967.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, collected from a donor who had multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Units F01160036, F01350036, F01842036.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Cincinnati, OH.
REASON Blood products, collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.

PRODUCT Platelets.
CODE Unit M84822.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit 0152938.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukoreduced.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
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 1 unit.
DISTRIBUTION TN.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Cryoprecipitated AHG.
CODE a) and b) Unit 22FK96155.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn Jersey Region, Philadelphia, PA.

REASON Blood product, collected from an ineligible donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 22GX86790, 22LJ61279, 22GX88251, 22KK53847, 22GL02181, 22GX88249, 22GL03432, 22KQ77905, 22KY68185, 22KQ80251, 22KN39879, 22GW84320, 22LY89558, 22LY89559, 22FC02366, 22KJ86705, 22KV49324, 22LJ63898, 22LJ61407, 22FJ79499, 22KP83903, 22FW91671, 22LJ61403, 22GW85331, 22KT50613, 22FQ06113, 22FQ06053, 22LW65828, 22FS13608, 22FC02795, 22LY91168, 22FC05447, 22GW87669, 22KK49767, 22LJ61398, 22LJ61410, 22GL02180, 22LY90436, 22LJ61404, 22LJ61411, 22KC45332, 22LY91166, 22LJ61414, 22FJ76871, and 22LY91663.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units.
DISTRIBUTION PA, NJ, MD, NY, and VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 27LG42571, 27LG42573, 27LG42572, 27LG42574, and 27LG42568.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA, WV, and MD.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 27GM66969.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Cryoprecipitated AHF.
b) Fresh Frozen Plasma.
c) Plasma.
CODE
a) Unit numbers 40FE63121, 40GC36624, 40GC44003, 40GE49395, and 40GR53922;
b) Unit numbers 40FQ32204, 40FR19351, 40FT13405, 40FT13496, 40GC74563, 40GH48138, and 40LR20977;
c) Unit numbers 40FC13332, 40FH25228, 40FR19045, 40FR19213, 40FT14459, 40FV09348, 40GC36624, 40GC44003, 40GE45027, 40GJ45926, 40GK28674, 40GR53922, 40LV01273, and 40LV01653.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL.

REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 5 units;
b) 7 units;
c) 14 units.
DISTRIBUTION IL, CA, GA, AL, NY, KY, MD, and Puerto Rico.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
c) Plasma.
CODE
a) Unit numbers 004E31856, 004E36041, 004F47692, 004F47781, 004J06720, 004L28769, 004L29186, 004L33969, 004LE21609,
004LE28881, 004LE31793, 004M00843, 004N00608, 004N95851, and 004R50766;
b) Unit numbers 004E31856, 004E48034, 004E54457, 004F94378, 004F99311, 004G32054, 004G33078, 004H13290, 004H14175,
004H16904, 004H22123, 004H23228, 004J06720, 004J40881, 004J41904, 004J43925, 004J93385, 004KF33157, 004KF33164,
004KF33167, 004KL55198, 004L28769, 004L29186, 004L33969, 004L37935, 004LE31793, 004LE34404, 004LE35484,
004M13291, 004N00608, 004N02880, 004N08177, 004N09303, 004N15283, 004N15605, 004N95851, 004R50766, and 004V93648;
c) Unit numbers 004C48321, 004C50132, 004E38244, 004FJ53043, 004FS34672, 004FS52923, 004J49423, 004KT27924, 004KT30330, 004KW50764, 004KW94327, 004R97281, and 004V00362.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 15 units;
b) 38 units;
c) 13 units.
DISTRIBUTION AR, NH, NY, MA, ME, VT, and Puerto Rico.

PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number E41298.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells.
CODE Unit numbers 3944106, 3944192, 3944141, 3944198, 3944200, 3944210, 3944217, 3944216, 3944219, 3944226, and 3944180
RECALLING FIRM/MANUFACTURER Dept. of the Army, U.S. Army Blood Bank, Center Fort Hood, TX.
REASON Blood products, collected from ineligible donors due to decreased hemoglobin values, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION TX, FL, WA, and VA.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers 2003-07-6045 and 2003-07-6046.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO.
Manufacturer: Heartland Lions Eye Banks, Kansas City, MO. Firm initiated recall is complete.
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 FL.

PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 8760522.
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX.
REASON Blood product, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that had been previously deferred for reactive testing for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 8755082.
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Units LX08481, LX08482, LX08484, LX08486, LX08488.
RECALLING FIRM/MANUFACTURER Inova Health System, Blood Donor Services, Annandale, VA.
REASON Blood products, collected without daily quality control being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 21GW35433, 21GW35434, 21GW35436, 21GW35437, 21GW35438, 21GW35439, 21GW35440, 21GW35441, 21GW35442, 21GW35443, 21GW35444, 21GW35445, 21GW35446, 21GW35447, 21GW35448.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Portland, OR.
REASON Blood products, manufactured using equipment that had not been quality controlled, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION WA and OR.

PRODUCT Fresh Frozen Plasma.
CODE Unit numbers 22GE68914, 22GW83714, 22KN39474, 22KQ77666, 22KV52853, 22KQ77745, 22KX49083, 22LQ93652, 22FJ79499, 22GE69423, 22GE70152, 22GX88251, 22KF40584, 22KN39879, 22KP83074, 22KQ77667, 22KQ77905, 22KT50613, 22KX53099, 22LY91574, 22FW91671, 22KP83853, 22KT51070, 22LY92464, 22FW90686, 22LQ97205, 22GK97803, 22KQ77739, 22KT51803, and 22FV99166.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION PA, NJ, MD, NY, and VA.

PRODUCT
a) Platelets.
b) Platelets Pheresis.
CODE
a) Unit numbers 27GV65689, 27GV65690, 27GT85267, 27GV65698, 27GV65701, 27GV65705, 27GV65707, 27GV65710, 27GV65712, 27GV65715, 27GX62779, 27GX62785, 27GX62786, 27GX62789, 27GX62796, and 27LF54256;
b) Unit numbers 27P62933 and 27P62931.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies, Region, Johnstown, PA.
REASON Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 16 units;
b) 2 units.
DISTRIBUTION PA.

PRODUCT Source Plasma.
CODE Unit numbers 0082503, 0082651, 0083204, 0083346, 0083896, 0084129, 0084267, 0084653, 0084848, 0086061, 0086201, 0086752, 0086843, 0087509, 0087643, 0088328, 0088483, 0088722, 0088899, 0089206, 0089395, 0089709, 0089968, 0090161, 0090361, 0090553, 0090824, 0091145, 0091632, 0091920, 0092191, 0092415, 0093968, 0094202, 0095281, 0095802, 0097697, 0097766, 0098241, 0098468, 0098929, 0099114, 0099373, 0099615, 0100065, 0100384, 0100562, 0100887, 0101095, 0101399, 0101580, CD0102028, CD0102378, CD0102605, CD0102705, CD0102926, CD0103059, CD0103245, CD0103453, CD0103570, CD0104697, CD0104840, CD0105054, CD0105202, CD0105448, CD0105633, CD0105864, CD0105962, CD0106906, CD0107285, CD0107753, CD0108080, CD0109071, CD0109588, CD0109724, CD0110047, CD0111004, CD0111498, CD0111670, CD0112048, CD0113149, CD0113577, CD0114177, CD0114485, CD0114862, CD0117743, CD0118132, CD0118444, CD0118831, CD0119171, CD0119202, CD0119435, CD0119530, CD0119913, CD0120074, CD0120469, CD0120771, CD0120955, CD0121251, CD0121475, CD0121766, CD0121952, CD0122352, CD9122518, CD0122789, and CD0122942.
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, Inc., Carbondale, IL.

REASON Blood products, collected from an ineligible donor due to a history of a chronic ulcerative condition, were distributed.
VOLUME OF PRODUCT IN COMMERCE 106 units.
DISTRIBUTION NC and NY.

PRODUCT Products: Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 040P93047, 40FP17029, 40FP17030, 40FP17033, 40FP17034, 40P93034, 40P93035, 40P93041, 40P93038, 40P93042, 40P93044, 40P93050, and 40FP17027; and the following units were distributed as two split products: unit numbers 40FP17028, 40P93047, 40P93045, and 40FP17032.
RECALLING FIRM/MANUFACTURER American National Red Cross, Heart of America Region, Peoria, IL.
REASON Platelets Pheresis incorrectly tested for platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION AL, TX and AZ.

WEEK ENDING SEPTEMBER 13

PRODUCT Platelets.
CODE Unit 22FJ83123.
RECALLING FIRM/MANUFACTURER American Red Cross, Penn Jersey Region, Philadelphia, PA.
REASON Platelets, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.

CODE Unit 9575567, 9575568.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit BFDTKP.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit N36575.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit N30407.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT Source Plasma.
CODE Unit G12679030.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Youngstown, OH.
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 Spain.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit 7412196.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and Switzerland.

PRODUCT Source Plasma.
CODE Unit BFFFDK.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Fort Worth, TX.
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number LSG016067.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Las Vegas, NV.
REASON Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit number LG0146446.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Las Vegas, NV.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 2947521.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number 8757108.
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX.
REASON Blood product that was possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

WEEK ENDING SEPTEMBER 20

PRODUCT
a) Red Blood Cells Leukocytes Removed.
b) Recovered Plasma.
CODE a) and b) Unit 2324685.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
REASON Blood products, which were collected from a donor at increased risk for nvCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and FL.

PRODUCT Platelets Pheresis.
CODE Unit number 8721125 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 042KF09241.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 20P15049.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturing Firm: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
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 UT.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 5106338-P2, 4708527-P1.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood product, corresponding to a unit of Platelets, that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Red Blood Cells for Further Manufacture.
e) Recovered Plasma.
CODE
a) Units 03FR22774, 03GQ02020, 03FL37606, 03W50954, 03LH02394, 03L76086, 03C25030;
b) Units 03FR22774, 03FL37606, 03L76086, 03C25030;
c) Units 03C25030, 03GM13736;
d) Unit 03GM13736;
e) Units 03FR22774, 03GQ02020, 03FL37606, 03W50954, 03LH02394, 03L76086.
RECALLING FIRM/MANUFACTURER American National Red Cross, Atlanta, GA.
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
a) 7 units;
b) 4 units;
c) 2 units;
d) 1 unit;
e) 6 units.
DISTRIBUTION CA, FL, GA, and MI.

PRODUCT Source Plasma.
CODE 0083696, 0083848, 0084203, 0084323, 0084593, 0084730, 0084973, 0085101, 0085318, 0085521, 0085674, 0085870, 0086008, 0086128, 0086350, 0086500, 0086683, 0086808, 0087046, 0087182, 0087436, 0087582, 0088000, 0088398, 0088742, 0089093, 0089295, 0089711, 0089795, 0090089, 0090320, 0090484, 0090763, 0090972, 0091485, 0091652, 0091840, 0092202, 0092312, 0092852, 0093201, 0093297, 0093553, 0093670, 0093776, 0093976, 0094033, 0094298, 0094420, 0095459, 0095647, 0096256, CD0102066, CD0102291, CD0102542, CD0102754, CD0102952, CD0103147, CD0103259, CD0103557, CD0103605, CD0103810, CD0103931, CD0104155, CD0104450, CD0104521, CD0104724, CD0104873, CD0105099, CD0105238, CD0105490, CD0105688, CD0105953, CD0106082, CD0106362, CD0106976, CD0107124, CD0107392, CD0107618, CD0107754, CD0107990, CD0108177, CD0108442, CD0108673, CD0108959, CD0109178, CD0109462, CD0109684, CD0109941, CD0110629, CD0110897, CD0111117, CD0111626, CD0112703, CD0113030, CD0113684, CD0113962, CD0114000, CD0114439, CD0114683, CD0115213, CD0115403, CD0115446, CD0115653, CD0115744, CD0116014, CD0116579, CD0117021, CD0117352, CD0119006, CD0119152, CD0119594, CD0119823, CD0120029, CD0120301, CD0120604, CD0120811, CD0121085, CD0122085, CD0122275.
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, LLC, Carbondale, IL.
REASON Blood products, collected from a donor who had sexual contact with someone who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 120 units.
DISTRIBUTION NC.

PRODUCT Source Plasma Units.
CODE N-26327-030, G-08078-030, G-08214-030, G-08776-030, G-09240-030, G-09416-030, G-09921-030, G-10184-030, G-10641-030, G-10977-030,

G-11374-030, G-12735-030, G-13420-030, F-01317-030, F-04482-030, F-05147-030, F-08389-030, F-09162-030, F-09835-030, F-10241-030,
F-10549-030, F-11107-030, F-11294-030, F-11849-030, F-12035-030, F-12534-030, F-12697-030, F-13407-030, F-19485-030.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA.
Manufacturer: Alpha Therapeutic Corporation, Youngstown, OH.
REASON Blood products, collected from a donor who had a tattoo applied within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION NC and Spain.

PRODUCT Source Plasma.

CODE 46-DCDJMC-A, 46-DCHMWG-A, 46-DCHMZF-A, 46-DCHNBX-A, 46-DCHNGD-A, 46-DCHNJR-A, 46-DCHNMC-A, 46-DCHNQW-A,
46-DCHNTS-A, 46-DCHNXJ-A, 46-DCHPCH-A, 46-DCHPZK-A, 46-DCHQCL-A, 46-DCHQKF-A, 46-DCHQNM-A, 460DCHQQD-A,
46-DCHQVB-A, 46-DCHQZQ-A, 46-DCHRHF-A, 46-DCHRLK-A, 46-DCHSGH-A, 46-DCHSJM-A.
RECALLING FIRM/MANUFACTURER Aventis Bio Services, Decatur, IL.
REASON Blood products, collected from a donor who had his tongue pierced within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION IL.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 2913844.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor whose hemoglobin was not documented on the donor’s record, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.

b) Liquid Plasma.
CODE
a) Units 34018260, 32014628, and 34029922;
b) Units 34018260, 31022777, 32014628, and 34029922.
RECALLING FIRM/MANUFACTURER W.E. and Lela Stewart Blood Center, Inc., Tyler, TX.
REASON Problem: Blood products, which were collected from a donor who was previously deferred for testing positive for the antibody to the human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION TX, FL, NJ, and Switzerland.

PRODUCT Source Plasma.
CODE Unit number 02DTXB4954.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Denton, TX.
REASON Blood product, 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 1 unit.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Unit numbers 02DTXA6835, 02DTXA7584, 02DTXA7808, 02DTXA8569, and 02DTXA8921.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Denton, TX.
REASON Blood products tested negative for viral markers but were collected from an ineligible donor due to a sign or symptom of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI.

PRODUCT
a) Platelets.
b) Platelets, Leukocytes Reduced.
c) Cryoprecipitated AHF.
d) Fresh Frozen Plasma.
e) Plasma.
f) Plasma, Cryoprecipitate Reduced.
CODE
a) Unit numbers 042FY95394, 042S63578, 042FW55290, 042FW55665, 042FG64632, 042T74613, 042Y97505, 042FY00188, 042FJ76799, 042K11492, 042FZ93471, 042T85923, 042FS58257, 042FR82077, 042FH92891, 042X24066, 042X25869, 042FT93444, 042T90219, 042FY14832, 042FX04567, 042FW75935, 042FH92877, 042FT88198, 042FE49600, 042T83167, 042Q64573, 042FX91758, 042FW78418, 042FG74880, 042K16815,
042Q64570, 042FH92672, 042FW55687, 042FW65610, 042FW93102, 042FG84467, and 042T80921;
b) Unit numbers 042K25967, 042S90951, 042FX13949, 042FY17347, and 042H35485;
c) Unit number 042R60850;
d) Unit numbers 042FZ93471, 042T85923, 042FR82077, 042FH92891, 042FH92877, 042FG64632, 042FG74880, 042FW75935, 042FW65610, 042K16815, 042K25967, 042FX04567, 042J33454, 042T86586, 042X24066, 042FH92672, 042FW55290, 042FW55665, 042S63578, and 042X25869;
e) Unit numbers 042K24502, 042GE04830, 042FY40741, 042S94511, and 042GE04006;
f) Unit number 042R60850.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 38 units;
b) 5 units;
c) 1 unit;
d) 20 units;
e) 5 units;
f) 1 unit.
DISTRIBUTION OH, CA, MI, and GA.

PRODUCT Source Plasma.
CODE Unit number BFFVXZ.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood product, that tested initially reactive for hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number 02OOKA7764.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Oklahoma City, OK.
REASON Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) Unit numbers 30GN65242 and 30GJ51928;
b) Unit number 30GJ51928.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells, Leukocytes, Reduced.
b) Recovered Plasma.
CODE
a) Unit 004KW11639;
b) Units 004KW11639, 004KW07567.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood products, collected from a donor with a history of having jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA.

PRODUCT
a) Red Blood Cells, Leukocytes, Reduced.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF.
d) Recovered Plasma.
CODE
a) Unit 27GM40196, 27GM30126;
b) Unit 27GM30126;
c) and d) Unit 27GM40196.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA.
REASON Blood products, which tested negative for hepatitis but were collected from a donor who subsequently tested positive for an unknown type of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA, and WV.

PRODUCT
a) Red Blood Cells, Leukocytes, Reduced.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit number 53GL11404.
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 determination of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MD, CA, and Washington D.C.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 53FL01948.
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 2 units.
DISTRIBUTION MD and CA.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number KT07658.
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 2 units.
DISTRIBUTION VA and NJ.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number FW10483.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and VA.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 2944840.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood product, which was collected from a donor who presented for donation with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 20J70492.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: The American National Red Cross, Salt Lake City, UT.
REASON Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION UT.

PRODUCT
a) Red Blood Cells Leukocytes Removed.
b) Platelets Leukocytes Removed.
c) Fresh Frozen Plasma.
CODE a) b) and c) unit 936633.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products, which were collected from a donor who had a medical history of Herpes Simplex, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH and KY.

PRODUCT Platelets.
CODE Unit 2956604.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor in which the question concerning having taken any medications of drugs was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 29913165.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor in which there was no documented response to the question concerning having had a major illness or surgery within the past twelve months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF.
CODE
a) Units 4129089, 5613515, 6413969, 6624662, 5744240.
b) Unit 7551255;
c) Unit 2194972.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, lacking assurance of proper temperature storage during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL and WI.

PRODUCT Source Plasma.
CODE Unit F-01321-036.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA
Manufacturer: Alpha Therapeutic Corporation, Cincinnati, OH.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells for Further Manufacturer into Non-Injectables.
CODE Unit JT52669.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc., Memphis, TN.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 26115-4757.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR.
REASON Blood product, incorrectly tested for cytomegalovirus (CMV), but labeled CMV negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AR.

PRODUCT Platelets.
CODE Unit number R49589.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 182313956.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who had an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY.

PRODUCT Source Plasma.
CODE Unit number FJMVLS.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Roanoke, VA.
REASON Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

WEEK ENDING SEPTEMBER 27

PRODUCT Platelet Pheresis.
CODE Unit M48122.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Blood product, with platelet count below the specified minimum requirements, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Recovered Plasma.
CODE Unit 03LX19619.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Service, Southern Region, Atlanta, GA.
REASON Blood product, collected from an ineligible donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) and d) Unit FG64742;
b) and c) Unit FK70653.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., DBA Rhode Island Blood Center, Providence, RI.
REASON Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY, and RI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) FJ97316.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., DBA Rhode Island Blood Center, Providence, RI.
REASON Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION RI.

PRODUCT Red Blood Cells.
CODE Unit 1954266.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood product, collected from a donor who traveled to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Plasma.
CODE a), b), and c) Unit # 53FC23771.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from an ineligible donor due to a history of medication with the drug Acyclovir, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MD and Washington, D.C.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit numbers 20Q12582 and 20M24110.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Deglycerolized.
CODE Unit number 40LC14524.
RECALLING FIRM/MANUFACTURER The American Red Cross Blood Services, Peoria, IL.
REASON Red Cells, which exceeded the firm's specifications for free hemoglobin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells.
CODE Unit number 4001301.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie, PA.
REASON Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Source Plasma.
CODE Unit number 90472657.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN.
REASON Blood product, collected from a donor that did not answer 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 CA.

PRODUCT Source Plasma.
CODE Unit number 91448033.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN.
REASON Blood product, collected from a donor that did not answer 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 CA.

PRODUCT Source Plasma.
CODE Unit number 90474064.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN.
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit number KP80346.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN.
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Platelets.
CODE Unit number K16779.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product that was lipemic was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Source Plasma.
CODE Unit number 76269639.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN.
REASON Blood product, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 15396-1876.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood product, manufactured from a unit of Whole Blood designated as a difficult collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.

CODE Unit number 042GW00043.

RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, collected from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 042KP08368, 042KP08371, 042KF09363, 042KF09398, 042KW16534, 042KP08430, 042KP08487, 042KF09518, and 042KW16480.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Platelets Pheresis incorrectly tested for platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION OH, and MI.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Units 16GW11943, 16KC22833, 16KC94032, 16LS94382, 16LS92361 and 16LR51844.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH.
REASON Blood product, which was prepared greater than 8 hours after the collection of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit number 6843948.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc., East Orange, NJ.
REASON Blood product, that was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) unit number 6851747.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc, East Orange, NJ.
REASON Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Source Plasma.
CODE Unit number 7030115824.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., San Antonio, TX.
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION United Kingdom.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit number 6151817.
RECALLING FIRM/MANUFACTURER Community Blood Center, Inc., Appleton, WI.
REASON Blood product, which was not properly irradiated and had an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.