JULY 2004

WEEK ENDING JULY 3

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE
a) Unit 41GQ85089;
b) Units 41GQ02366, 41GQ00829, 41GQ92266, 41FQ87938, 41FQ88753, 41GQ95446, 41GQ93737, 41GQ90736, 41GQ87206;
c) Units 41FQ88753, 41FQ87938.
RECALLING FIRM/MANUFACTURER American National Red Cross, Alabama Region, Birmingham, AL.

REASON Blood products, mislabeled as a licensed transfusable product and/or as collected from a volunteer donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION AL and TX.

PRODUCT Human Tissue for Transplantation (Corneas).
CODE Cornea # 2004-04-6031, 2004-04-6032.
RECALLING FIRM/MANUFACTURER Heartland Lions Eye Bank, Northwoods Office Complex, Kansas City, MO.
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for anti-hepatitis C virus (anti-HCV) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 corneas.
DISTRIBUTION TX and MO.

PRODUCT Human Cornea Tissue.
CODE Tissues 2004-04-5003, 2004-04-5004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO.
Manufacturer: Heartland Lions Eye Bank, Berkeley, MO.
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 CA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Units 4235804, 4235826, 4235829, 4232323, 4235810, 8418826, 4232740, 4238140, 4232514, 4232517, 4232519,
4235013, 4232729, 4232786, 4232799, 4232800, 4235126, 4235132, 4233011, 4235818, 4232322, 4235875, 3923184,
4232720, 4232737, 3923189, 4232320, 4232324, 4235803, 4232513, 4235874, 4235008, 4232750, 4235129, 4233010,
8418801, 4235033, 4235037, 4235039, 3923191, 4232318, 4235828, 4232520, 4235871, 4235017, 4232726, 4232775,
4232790, 4235125, 4235128, 4233014, 4233015, 4233017;

b) Units 8286304, 4232551, 4235014, 4232319, 4232550, 4235022, 4233008, 4235045, 4234795, 4235808, 4235811,
4235814, 4235878, 4235817, 4235877, 4232563, 4238101, 4238106, 4238116, 4235872, 4235881, 4235009, 4235879,
4235031, 4234797, 4235825, 4235822, 4235823, 4232555, 4238107, 3930435, 4234800, 4235027, 4234798, 4235876,
4235883, 8418807, 8418816, 4235021, 4235036, 4238014, 3930471, 3923193, 4235882, 4235019, 4232762, 4238024,
4237827, 4235880, 4237833, 4232515, 4238131, 4232747;
c) Unit 4232764.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 103 units.
DISTRIBUTION IN.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: L434487 (2 parts).
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI.
REASON Blood products, collected from an unsuitable donor due to the use of the drug, Relafen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 11LN03949.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Missouri-Illinois Region, Saint Louis, MO.
REASON Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 24GZ11568.
RECALLING FIRM/MANUFACTURER American National Red Cross, River Valley Region, Louisville, KY.
REASON Blood products, which were collected from a donor whose blood donation record contained contradictory Confidential Unit Exclusion stickers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units 2327082, 2326154, 2323585, 1704149, 1702729;
b) Units 2323585, 1704149;
c) Units 2326154, 1702729.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX.
REASON Blood products, which tested negative for hepatitis but were collected from a donor who disclosed a previous positive test for hepatitis and was improperly reinstated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION TX, DC, and Switzerland.

PRODUCT Source Plasma.
CODE Unit numbers: ST323408, ST323790, ST324131, and ST324474.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Antonio, TX.
REASON Blood products were not properly quarantined after the donor disclosed 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 4 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 042K55575.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number R20952.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.
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 WI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number LS86931.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.
REASON Blood products collected from an ineligible donor based on the disclosure of a family member diagnosed with Creutzfeldt-Jakob Disease (CJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FW44987C.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.
REASON Blood PRODUCT, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.

PRODUCT Recovered Plasma.
CODE Units 41GQ02366, 41GQ00829, 41GQ95446, 41GQ93737, 41GQ92266, 41GQ90736, 41GQ87206, 41GQ85089.
RECALLING FIRM/MANUFACTURER American National Red Cross, Alabama Region, Birmingham, AL. REASON Blood products, mislabeled as a licensed transfusable PRODUCT and/or as collected from a volunteer donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION CA, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 3944956.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON Blood product, that was not quarantined after receiving information concerning a post donation infection in the arm used for blood donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT
a) Red Blood Cells.

b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Units 4235116, 4235120, 4233016, 4233019, 4235381, 3930484, 4232757, 4232776, 4235121, 4235134, 4233009,
4233012, 4233018, 4237829, 4237831, 4237844, 3930482, 4235124, 4235815;
b) Units 4235379, 4235041, 4235820, 4238121, 4237837, 3933070, 4232559, 4238096, 3930435, 4238014, 3930471,
4237827.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION IN.

WEEK ENDING JULY 10

PRODUCT Source Plasma.
CODE Units 67794836, 67790791, 67787111, 67782895, 67779048, 67755479, 67738946, 67728664, 67716500, 67698554, 67694884, 67690466, 67678457, 67670413, 67655441, 67651924, 51811921, 51807443, 51804039, 51800383, 51797058.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL.
Manufacturing Firm:  Plasma Biological Services, Inc., Johnson City, TN.
REASON Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FW41677.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc. Milwaukee, WI.
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 WI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 17FJ21332.
RECALLING FIRM/MANUFACTURER The American National Red Cross, North Central Region, St. Paul, MN.
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 WI.

PRODUCT Recovered Plasma.
CODE Unit number 49GR60806.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 49LW09869.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
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 OK.

WEEK ENDING JULY 17

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 311345919, split units.          
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood products, manufactured in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets Pheresis, Leukocytes Reduced.
d) Recovered Plasma.

CODE
a) Unit number 49LE01482;
b) and d) Unit numbers 49LF50316, 49LH51129, and 49LJ47232;
c) Unit number 49LP08923.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, that tested negative for antibodies to 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 8 units.
DISTRIBUTION TX, CA, MD, and Switzerland.

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

CODE a) and b) Unit numbers: 49GW02364, 49GW04399.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.           
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.  
CODE Unit number: 49GV13288.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets.
CODE Unit V16129.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Fresh Frozen Plasma.
CODE Unit V00919.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit V03839.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT
a) Platelet pheresis, leukoreduced.
b) Platelet pheresis, leukoreduced, irradiated.
CODE Unit 18KT00457.
RECALLING FIRM/MANUFACTURER American National Red Cross, Lansing, MI.
REASON Blood Products, which were collected in an apheresis collection kit that may have exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTIONMI.

PRODUCT Platelets.
CODE Unit V04079.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit numbers: K54162, K54160.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Harrisonburg, VA.
REASON Blood products, without platelet quality control being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
c) Platelets Pheresis, Leukocytes Reduced.
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
e) Fresh Frozen Plasma.
f) Plasma, Frozen.
g) Red Blood Cells, For Manufacturing Use Only.
h) Recovered Plasma.
CODE
a) Unit numbers: 40FF51296, 40FF51405, 40FF51479, 40FF51604, 40FF51657, 40FF51800, 40FF51838, 40FF51877,
40FF51968, 40FF51998, 40FF52129, 40FF52254, 40FF52264, 40FF52289, 40FF52457, 40FF52659, 40FF52674, 40FF52766, 40FF52771, 40FF53014, 40FF53115, 40FF53274, 40FF53342, 40FF53648, 40FF53690, 40FF53731, 40FF53757, 40FF53955, 40FF54040, 40FF54053, 40FF54211, 40FF54214, 40FF54346, 40FF54350, 40FF54372, 40FF54381, 40FF54440, 40FF54576, 40FF55054, 40FF55105, 40FF55120, 40FF55131, 40FF55190, 40FF55492; 40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317, 40FQ31357, 40FQ31366, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772, 40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32061, 40FQ32085, 40FQ32195, 40FQ32253, 40FQ32279, 40FQ32337, 40FQ32341, 40FQ32363, 40FQ32430, 40FQ32460, 40FQ32526, 40FQ32555, 40FQ32606, 40FQ32721, 40FQ32736, 40FQ32753, 40FQ32768, 40FQ32843, 40FQ33067, 40FQ33152, 40FQ33183, 40FQ33427, 40FQ33609, 40FQ33658, 40FQ33673, 40FQ33787, 40FQ33798, 40FQ33973;
b) Unit numbers: 40FF51164, 40FQ31378, 40FQ31694;
c) Unit numbers: 40FP16037-2, 40FP16497-1, 40FP16746-1, 40FP17118-1, 40FP17118-2, 40FP18019-1, 40FP18019-2;
d) Unit numbers: 40FP15763-1, 40FP16746-2;

e) Unit numbers: 40FQ31694, 40FQ32061, 40FQ32768, 40FQ33658, 40FQ33673, 40FQ33787;
f) Unit numbers: 40FF52129, 40FF54440, 40FF55105, 40FF55120, 40FQ32279, 40FQ32341;
g) Unit number: 40FQ32200;
h) Unit numbers: 40FF51164, 40FF51174, 40FF51296, 40FF51405, 40FF51479, 40FF51604, 40FF51657, 40FF51800,
40FF51838, 40FF51877, 40FF51968, 40FF51998, 40FF52254, 40FF52264, 40FF52289, 40FF52457, 40FF52655, 40FF52659, 40FF52674, 40FF52766, 40FF52771, 40FF53014, 40FF53115, 40FF53274, 40FF53342, 40FF53648, 40FF53690, 40FF53731, 40FF53757, 40FF53955, 40FF54040, 40FF54053, 40FF54211, 40FF54214, 40FF54346, 40FF54350, 40FF54372, 40FF54381, 40FF54576, 40FF55054, 40FF55131, 40FF55190, 40FF55492, 40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317, 40FQ31357, 40FQ31366, 40FQ31378, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772, 40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32085, 40FQ32195, 40FQ32200, 40FQ32253, 40FQ32337, 40FQ32363, 40FQ32430, 40FQ32460, 40FQ32526, 40FQ32555, 40FQ32606, 40FQ32721, 40FQ32736, 40FQ32753, 40FQ32843, 40FQ33067, 40FQ33152, 40FQ33183, 40FQ33427, 40FQ33609, 40FQ33973, 40FQ33798.
RECALLING FIRM/MANUFACTURER American National Red Cross, Heart of America, Peoria, IL.
REASON Blood products, collected from donors whose medical history screening regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD) was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 199 units.
DISTRIBUTION Nationwide and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 49LQ35151.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 49GQ40739, 49GQ40744, 49GQ40749, 49GQ40750, and 49GQ40751.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION TX, and OK.

WEEK ENDING JULY 24

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.

b) Recovered Plasma.
CODE a) and b) Unit numbers: 49N32683, 49LK39235.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a repeatedly reactive HIV-p24 antigen, Western Blot indeterminate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MD, TX, Switzerland, and Israel.

PRODUCT Source Plasma.Units.
CODE 0520272204, 0520271809, 0520271325, 0520269987, 0520271128, 0520269666, 0520269134, 0520268929, 0520232140, 0520231353.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL.

Manufacturing Firm: ZLB Bioplasma Inc., Memphis, TN.
REASON Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION United Kingdom.

PRODUCT Source Plasma.
CODE Units: 67692606, 67689804, 67682942, 67679102, 67676088, 67672714, 67669592, 51863753, 51757854, 51752866.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL.
Manufacturing Firm: Plasma Biological Services Inc., Johnson City, TN.
REASON Blood products, collected from a donor who may have received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Units: 67893843, 67889457.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL.
Manufacturing Firm: Plasma Biological Services Inc., Johnson City, TN.
REASON Blood products, collected from a donor whose medical history was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Units: 63639735, 63635461, 63632552, 63626537, 63624533, 63619690, 63614954, 63612615, 63608885, 63603514, 63599374, 63595345, 63590012, 63583649, 63581379.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL.
Manufacturing Firm: ZLB Bioplasma Inc., Baton Rouge, LA.
REASON Blood products, collected from a donor whose scheduled physical exam had not been performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 49K56260.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 49FF50224, 49FF49108, and 49LQ45615.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.
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 TX and OK.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 53GE80761, 53GV54236, and 53Y01505.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
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 MD and VA

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODEUnit numbers 53FC33385, 53FC31641, and 53FC27941.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
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 MD and DC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 53Y05184.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Red Blood Cells.
CODE Unit number 8731397.
RECALLING FIRM/MANUFACTURER Union Memorial Hospital Blood Bank, Baltimore, MD.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT Source Plasma.
CODE Unit numbers: 450001386, 450001670, 450002036, 450002333, 450003085, 450004477, and 450005153.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Hampton, VA.
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION Spain.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 53FX94889.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, collected from a donor who has a history of Sarcoidosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Plasma, Frozen.
d) Plasma Frozen, Cryoprecipitate Reduced.
e) Cryoprecipitated AHF.
f) Red Blood Cells, For Further Manufacturing into Injectables.
CODE
a) Unit numbers: 53G42341, 53GE44107, 53L28828;
b) Unit numbers: 53G42341, 53GE44107;
c) Unit numbers: 53G48235, 53G42341, 53GE44107, 53L28828;
d) e) and f) Unit number: 53GN39869.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from an ineligible donor due to a subsequent disclosure of previous positive Hepatitis B testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION MD, CT, FL, MI, and D.C.

PRODUCT Platelet Pheresis, Leukoreduced.
CODE Units: 53LT81231, 53LT80755, 53LT81189, 53LT81143 (split) 53LT81101 (split), 53LT80069.
RECALLING FIRM/MANUFACTURER American National Red Cross, Baltimore, MD.
REASON Blood Products, labeled “leukoreduced” but which were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION MD.

PRODUCT Red Blood Cells.
CODE Unit number: L09275.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, collected from a donor who provided post donation information of having Hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 49LL12935.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.

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 TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 49LQ25365.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product, collected from a donor who had resided in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit number 2055126.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc, Lexington, KY.
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 KY.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 042X90236.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Platelets.
CODE Unit number K96110.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit number K99667.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Source Plasma.
CODE Unit numbers: OT093053, OT089436, OT088102.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Odessa, TX.
REASON Blood products, that were not properly quarantined after the receipt of repeatedly reactive anti-HCV, RIBA indeterminate results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukoreduced.
CODE Unit: 49GQ34075.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tulsa, OK.
REASON Blood product, collected from a donor who had resided in a malarial endemic area within the past three years, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units: 1770435, 8070190;
b) Unit: 1770435;
c) Unit: 8070190.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, collected from a donor who had had previously been permanently deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION IL and Scotland.

PRODUCT Fresh Frozen Plasma.

CODE Unit 2472056.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood product, corresponding to Platelets and Red Blood Cells that were contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Platelets Pheresis.
CODE Units 040P98472-1, 040P98472-2.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL.
REASON Blood products, labeled as leukoreduced, but which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit: 6152287.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, that tested negative for all viral markers, but which were collected from a donor who reported a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.

b) Source Leukocytes for Further Manufacturing of Non-Injectable.
CODE a) and b) Unit 4380836.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.

REASON Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma for Further Manufacture of Non-Injectables.
CODE a) and b) Units 49X55421, 49G70461.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, which 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 OK and MA.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 49GQ33293.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK.

REASON Blood product, with an unacceptable hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced..
CODE Unit 71W43194-4 (split #1).
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Gainesville, FL.
REASON Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 71W58014-X (split #2).
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Gainesville, FL.
REASON Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelet Pheresis, Leukoreduced.
CODE Unit: 71 W57537-4.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL.
REASON Blood Product, prepared in insufficient plasma to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit split product).
DISTRIBUTION FL.

PRODUCT Platelet Pheresis, Leukoreduced.
CODE Unit: 71 W58273-4.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL.
REASON Blood Products, prepared in insufficient plasma to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units, (split product).
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit FQ41761.
RECALLING FIRM/MANUFACTURER Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI.
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 49KL00694.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
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 OK.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: FQ43674.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI.
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 WI.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit number: KC05000;
b) Unit number: LS90153.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI.
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 WI and PA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 49LV03322.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, which were collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 33GY77132.
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit FG81282.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., DBA Rhode Island Blood Center
Providence, RI.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA and RI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 7793801.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.

REASON Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT
a) Red Blood Cells.

b) Platelets.
CODE
a) GR46907, KE64714, KE64717, KK6752, KK67526, KK67528, LK26089, LK26096, LR50338, LR50339, LR50340, LR50341, LR50342, LR50344, LR50348, LR50349, LR50350, GR46897;
b) GR46906, GR46907, GR46908, GR46909, KE64713, KE64714, KE64715, KE64717, KE64718, KK67522, KK67523, KK67524, KK67525, KK67526, KK67527, LK26089, LK26093, LK26096, LK26098, LR50337, LR50339, LR50340, LR50341, LR50342, LR50348, LR50350, GR46897.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood products, that were not tested for NAT-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units.
DISTRIBUTION PA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 2076206.
RECALLING FIRM/MANUFACTURER Recalling Firm: Central Kentucky Blood Center, Inc., Lexington, KY.
Manufacturing Firm: Tacoma Pierce County Blood Bank, dba Cascade Regional Blood Services, Tacoma, WA..
REASON Blood product, which was bacterially contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Platelets.
CODE Unit number: W90171.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Traverse City, MI.
REASON Blood Product, collected from a donor who reported having a headache with fever during the week before donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Removed, Irradiated.
CODE Unit number: 6055465.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 29GV56388, 29GV56389, 29GV56390, 29GV56392, 29GV56394, 29GV56397, 29GV56398, 29GV56408, 29GV56413, 29GV56416, 29GV56417, 29GV56419, 29GV56420, 29GV56421, 29GV56424, 29GV56425, 29GV56427, and 29GV56429.
RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, collected using trip scales that lacked quality control documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION VA and NC.

PRODUCT
a) Platelet pheresis, leukoreduced.
b) Platelet pheresis, leukoreduced, irradiated.
CODE
a) Units: 29FP92590, 29FP92578 (split);
b) Units: 29FP95282, 29FP92578 (split).
RECALLING FIRM/MANUFACTURER American National Red Cross, Norfolk, VA.
REASON Blood Products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA, NC and PA.

PRODUCT Source Plasma.
CODE Unit number FJSZWZ.
RECALLING FIRM/MANUFACTURER International BioResources, LLC, (formerly Aventis Bio-Services), Roanoke, VA.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 49GN15128, 49GM01458, 49GN16396, 49GC02349, 49GW00301, 49GC02363, 49GC02365, 49GC01694, 49GM01457, 49GW04222, 49GW04149, 49GN15129, 49GW03899, 49GW03897, 49GW03898.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION OK and TX.

PRODUCT Red Blood Cells.
CODE Unit numbers: FT05124, FT05125, FT05127, FT05128, GP54711, GV50346, GV50363, GV50364, KC68892, KC68904, KC68915, KC68931, KH44770, KJ56017, KJ56019, KJ56020, KM08189, KM08190, KM08191, KM08192, KM08193, KM08196, KM08198, LR43493, LR43495, LR43496, LR43498, LR43501, LR43504, LR43505, LR43508, LR43511, LR43512, LR43513, LR43527, LR43532, LR43535, LR43536, LR43542, LV32119, LV32128, LV32130, and LV32133.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood products, manufactured without the entire quantity of additive solution added, were distributed.
VOLUME OF PRODUCT IN COMMERCE 43 units.
DISTRIBUTION WV, OH, and PA.