JULY 2010
WEEK ENDING JULY 31
PRODUCT Source Plasma.
CODE
Units: 0540694599; 0540680948; 0540677294; 0540675308
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Louisville, KY,
REASON Blood products, collected from a donor whose physical
exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION
Switzerland, IL
PRODUCT
1) Platelets,
2) Red Blood Cells.
CODE
1) Unit: 3878524;
2) Unit: 3900206
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK
REASON Blood products, collected from donors who were
previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY, CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Units: X73159; X48910
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN,
REASON Blood products, collected from a donor considered to be
at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION TN, GA, Korea
PRODUCT
1) Plasma Frozen within 24 hours (FP24).
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 041FT06668
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross Blood Services, Alabama Region,
Huntsville, AL.
REASON Blood products, collected from a donor whose suitability
to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL
PRODUCT
1) Cryoprecipitated AHF.
2)
Red Blood Cells.
3) Fresh Frozen Plasma. CODE
1) Units: 53FH53811; 53FH51111; 53FH38995;
2) Units: 53FH51111; 53FH53811; 53FH34443; 53FH37002; 53FH38995; 53FH41019;
3) Unit: 53FH37002
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross-Greater Chesapeake and
Potomac Region, Baltimore, MD
REASON Blood products, collected from a donor whose suitability
to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION DC, MD, NC
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE Unit: LV24186
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI,
Manufacturer: BloodCenter of Wisconsin, Inc., Kenosha, WI.
REASON Blood product, collected from a donor who reported
travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Source Plasma.
CODE
Units: 0530610953, 530610212, 530609324, 530608415, 530607274, 530606678,
530605139, 530604848, 530603447, 530601759, 530601471, 5306000046, 530598857
RECALLING FIRM/MANUFACTURER
CSL Plasma, Lexington, KY,
REASON Blood products, collected from a donor who did not
receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units
DISTRIBUTION
IL, Germany, Switzerland
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Unit: GP53048
RECALLING FIRM/MANUFACTURER
Blood Bank Of San Bernardino and Riverside Counties, San Bernardino, CA, .
REASON Blood products, collected from a donor considered to be
at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA, Austria
PRODUCT Red Blood
Cells.
CODE
Units: W012708002803; W012708001705
RECALLING FIRM/MANUFACTURER
Department of Army William Beaumont Army Medical Center, El Paso, TX,
REASON Blood products, collected from a donor with a history of
hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Units: W249709900392; W249709900392
RECALLING FIRM/MANUFACTURER
Cumberland County Hospital System, Inc., Fayetteville, NC,
REASON Blood products, collected from a donor whose suitability
to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC
PRODUCT Source Plasma.
CODE
Units: 4080311265, 4080307585, 4080301710, 4080298495, 4080291465, 4080285663
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Akron, OH,
REASON Blood products, collected from a donor whose scheduled
physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION IL
PRODUCT Source Plasma.
CODE
Units: 4040077035, 4040076573, 4040076194, 4040075561, 4040075216, 4040072719,
4040072149, 4040071765, 4040070992, 4040070670, 4040069884, 4040069565,
4040068705, 4040068453, 4040059946, 4040059253, 4040058935, 4040058228,
4040057972, 4040057002, 4040056668, 4040055976, 4040055494, 4040054847,
4040054435, 4040053761, 4040053395, 4040052721, 4040052346, 4040051743,
4040051485, 4040050883, 4040050387, 4040049902, 4040049389, 4040049028,
4040048469, 4040048166, 4040047293, 4040046766, 4040046463, 4040045606,
4040045192, 4040044769, 4040044273, 4040043743, 4040043226, 4040042685,
4040042349, 4040041877, 4040041569, 4040041117, 4040040805
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL,
Manufacturer: ZLB Bioplasma Inc., Lexington, KY.
REASON Blood products, collected from a donor whose scheduled
physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 53 units
DISTRIBUTION
IL, Switzerland, Germany
PRODUCT Recovered
Plasma.
CODE Unit: P87454
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA,
REASON Blood product, collected from a donor who was at risk
for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
Switzerland
PRODUCT Source Plasma.
CODE
Unit: YZ029044
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank, Inc. of Wisconsin, Memphis,
TN,
Manufacturer: Interstate Blood Bank, Inc. of Wisconsin, Milwaukee,
WI.
REASON Blood product, collected from a donor with a history of
incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72N290984
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL
REASON Blood product, with an absolute red cell volume below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Source Plasma.
CODE
Units: 4020446964, 4020445016, 4020444151, 4020442085, 4020434766, 4020430201,
4020423504, 4020421900
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Akron, OH,
REASON Blood products, collected from a donor who received a
body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION
IL, Switzerland
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72L152973
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL
REASON Blood product, which was inappropriately distributed in
a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Source Plasma.
CODE Units: 4100303755, 4100302732, 4100300513
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Kansas City, MO,
REASON Blood products, collected from a donor who received a
tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72L690370
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL
REASON Blood product, which was inappropriately distributed in
a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72M851118
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL,
REASON Blood product, which was inappropriately distributed in
a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma. CODE
1) and 2) Unit: 49GV35518
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK,
REASON Blood products, collected from a donor whose suitability
to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX, OK
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72N068482
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N492730
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Red Blood
Cells Leukocytes Reduced. CODE Unit: 55S55641
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL, AR
PRODUCT Red Blood
Cells Leukocytes Reduced. CODE
Units: W224308500657, 662268, W224310510603, W224309503401
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA,.
REASON Blood products, collected from a donor who reported
travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA
PRODUCT Red Blood
Cells Leukocytes Reduced. CODE Unit: 6204408
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX
REASON Blood product, collected from a donor who traveled to an
area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Recovered
Plasma.
CODE
Unit: W036509031626
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA,
REASON Blood product, collected from a donor considered to be
at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
Switzerland
PRODUCT
Cryoprecipitated AHF, Pooled.
CODE
Unit: W037910110761
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA,
REASON Blood product, collected from a donor whose suitability
to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IA
PRODUCT Source Plasma.
CODE
Unit: LC0635830
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM
REASON Blood product, collected from a donor who reported post
donation information regarding a body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT
1) Plasma Frozen.
2) Red Blood Cells.
3) Fresh Frozen Plasma. CODE
1) Units: W038509801565; W038508331750;
2) Units: W038509801565; W038508331750; 4133133;
3) Unit: 4133133
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,
REASON Blood products, collected from a donor considered to be
at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION GA, SC
PRODUCT
1) Cryoprecipitated AHF.
2)
Red Blood Cells.
3) Plasma.
CODE
1) Unit: 4132630;
2) and 3) Units: W038508340256, 4132630
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,
REASON Blood products, collected from a donor who was
previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION
Korea, Republic OF (South); GA
PRODUCT
Apheresis Platelets Irradiated Leukocytes Reduced-7D. CODE
Unit: 4759300 (2 Units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL
REASON Blood products, with positive bacterial detection
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: W043210019652 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN,
REASON Blood products, labeled leukoreduced without the
assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION TN, GA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Unit: W118809203823
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., St Augustine, FL,
REASON Blood products, collected from a donor with a history of
Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION
Switzerland, FL
PRODUCT
Source Plasma. CODE Unit: 09EINA1862
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Elkhart, IN,
REASON Blood product, collected from a donor whose scheduled
physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT
Source Plasma. CODE
Units: 0490718560, 0490721730, 0490720322
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prairie, TX,
REASON Blood products, collected from a donor whose scheduled
physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IL
PRODUCT Source Plasma.
CODE
Units: 6140261957, 6140259890
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Evansville, IN,
REASON Blood products, collected from a donor whose scheduled
physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
W051510031497 (2 units)
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON Blood products, which were labeled as leukoreduced, but
had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH, NY
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Units: LJ61398, KL19674, FS17402;
2) Units: KF40804 (part 1), KF40804 (part 3)
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI,
REASON Blood products, for which storage conditions and
shipment information were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION WI
PRODUCT
1) Platelets Pheresis Leukocytes Reduced.
2) Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
1) and 2) Unit: 9868176
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON Blood products, which were possibly contaminated with
gram positive rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT Red Blood
Cells Leukocytes Reduced. CODE Unit: W045010012021
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO,
REASON Blood product, which did not have red cell preservative
solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KS
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: KF67456
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI,
Manufacturer: BloodCenter of Wisconsin, Inc., Waukesha, WI.
REASON Blood product, collected from a donor who received the
shingles vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Red Blood
Cells Leukocytes Reduced. CODE
Unit: W044608203256
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on February
REASON Blood product, manufactured without the additive
solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Recovered
Plasma.
CODE
Unit: 55S55641
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL, AR
PRODUCT Recovered
Plasma.
CODE
Unit: W041608052498U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS
Manufacturer: Blood Systems Inc/dba United Blood
Services, Hattiesburg, MS.
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
Switzerland
WEEK ENDING JULY 24
PRODUCT
Source Plasma,CODE
Units: 09VMNM6140, 09VMNM4297, 09VMNL8158, 09VMNL6969, 09VMNL0562, 09VMNK8176, 09VMNK5683, 09VMNK4450, 09VMNK0982, 09VMNJ7794 and 09VMNJ4860
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Mounds View, MN,
REASON
Blood products, collected from a donor who had not had an annual physical performed, were distributedVOLUME OF PRODUCT IN COMMERCE
11 unitsDISTRIBUTION
CA
PRODUCT
Source Plasma,CODE
Units: 4920206775, 4920205016, 4920203888, 4920203241, 4920198342, 4920197920, 4920196898, 4920196384, 4920195250, 4920194746, 4920193637, 4920193115, 4920191644, 4920190213, 4920189291, 4920188842, 4920187437, 4920186141, 4920185273, 4920184886, 4920183704, 4920182733, 4920180857, 4920179969, 4920179518, 4920170811, 4920169878, 4920169439, 4920168495, 4920168123, 4920167239, 4920166812, 4920165914, 4920165466, 4920164582, 4920164150, 4920163324, 4920162938
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Boca Raton, FL,
Manufacturer: CSL Plasma, Springfield, OH.
REASON
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
IL, Germany, Switzerland
PRODUCT
Red Blood Cells,CODE
Unit: 6059180RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON
Blood product, which was collected from a donor who traveled to a malarial endemicarea, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
OH
PRODUCT
Source Plasma,CODE
Units: 0530622293, 0530620404, 0530618722, 0530617861, 0530617047, 0530616124, 0530615083, 0530614455, 0530613150, 0530612740, 0530611053, 0530610490, 0530609346, 0530608732, 0530607573, 0530606970, 0530605820, 0530605309, 0530604211, 0530603610, 0530602636, 0530602065, 0530600978, 0530599819, 0530599356, 0530598411, 0530597977
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Boca Raton, FL,
Manufacturer: CSL Plasma, Lexington, KY.
REASON
Blood products, collected from a donor whose physical examination was expired, were distributed.VOLUME OF PRODUCT IN COMMERCE
27 unitsDISTRIBUTION
IL, Germany, Switzerland
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72M913057RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 19LR15032RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
REASON Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
TN
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced Irradiated.
CODE
1) Unit: 22FM06806;
2) Unit: 22KC95930
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood products, which were labeled as negative for the S antigen, but were collected from a donor who subsequently tested positive for S antigen, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
PA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: 22LC33672
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributedVOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
PA
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72N116982RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72M734461RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72M912884RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72N337557RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
AL
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72N10496XRECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72M694354RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA,
REASON
Blood product, with a low platelet count, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
GA
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: 72N11739XRECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with a platelet count below the specified minimum requirement, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
AL
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 03FM47035RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
REASON
Blood product, collected from a donor whom donor suitability was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
GA
PRODUCT
Source Plasma.CODE
Unit: 09DIAL2608RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Dubuque, IA,
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets.
CODE
1) and 2) Unit: 01KX00785
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY,
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
PA, NY
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 53K56871RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD,
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
MD
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 53J29500RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD,
REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
MD
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Leukocytes Reduced.
CODE
1) Unit: W037709000423;
2) Unit: W0307709000423
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH,
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: Unit 38FV68983
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
IN, OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Pooled Leukocytes Reduced.
CODE
1) Unit: 42H60009;
2) Units: 42FX67497POOL; 42FX67520POOL; 42H60009POOL; 42H60004POOL; 42H60006POOL; 42H59997POOL; 42H60018POOL
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH
REASON
Blood products, possibly contaminated with air, were distributed.VOLUME OF PRODUCT IN COMMERCE
8 unitsDISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Units: 22GZ39134 and 22GM60502RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, .
REASON Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
NJ, PA
PRODUCT
Source Plasma.CODE
Units: 4240226541, 4240220002, 4240218712, 4240217265, 4240216761, 4240215513, 4240215160, 4240214045, 4240213506, 4240211631, 4240210895, 4240209695, 4240208742, 4240207633, 4240206837, 4240205362, 4240204790
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Davenport, IA,
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.VOLUME OF PRODUCT IN COMMERCE
17 unitsDISTRIBUTION
Switzerland, IL
PRODUCT
Source Plasma.CODE
Units: 4100364838, 4100361389, 4100356793, 4100347367, 4100342910RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Kansas City, MO, .
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.VOLUME OF PRODUCT IN COMMERCE
5 unitsDISTRIBUTION
IL
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 8883824RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Ocala, FL,
REASON
Blood product, collected from a donor who was previously deferred for testing repeat reactive for HTLV-I/II, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 24FW31505RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, Louisville, KY,
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
KY
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen.
CODE
Unit: 42FP27508RECALLING FIRM/MANUFACTURER
The American National Red Cross, Cleveland, OH,
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 24KE69016RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY,
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
KY
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 24GY32502RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY,
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
KY
PRODUCT
Source Plasma.CODE
Units: 09GUTD6504, 09GUTD8499, 09GUTD5081, 09GUTD4387, 09GUTD2986, 09GUTD2235, 09GUTC6434, 09GUTC5653. 09GUTC4209, 09GUTC3441, 09GUTC0173, 09GUTB9405, 09GUTB8011, 09GUTB7278, 09GUTB5903, 09GUTB5174 and 09GUTB3900
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Saint George, UT,
REASON
Blood products, collected from a donor who had not had an annual physical performed, were distributed.VOLUME OF PRODUCT IN COMMERCE
17 unitsDISTRIBUTION
CA
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE
Unit: W091009328162RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK,
REASON
Blood product, which was collected from a donor who had taken aspirin prior to the donation, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
OK
PRODUCT
1) Platelets Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 2956896;
2) Units: 2956896, 2924787
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH,
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
3 unitsDISTRIBUTION
OH, KY
PRODUCT
1) Recovered Plasma.
2) Red Blood Cells Leukocytes Reduced.
3) Fresh Frozen Plasma.
CODE
1) Unit: 6174086;
2) Units: 6205935, 6174086, 6142542;
3) Units: 6205935, 6142542
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX,
REASON Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 unitsDISTRIBUTION
Austria, TX
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.CODE
Unit: W037709086436RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH,
REASON
Blood product, which did not meet acceptable product specifications, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: 9648372RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
TX, NJ
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Units: 18FW73596RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI,
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
MI
PRODUCT
Red Blood Cells.CODE
Unit: W088409008173RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI,
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 unitDISTRIBUTION
HI
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets.
3) Plasma Frozen.
CODE
1), 2) and 3) Unit: P51128
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN,
REASON
Blood products collected from a donor who may have warranted deferral for residency in an area at risk for Creutzfeldt-Jakob Disease (vCJD) were distributed.VOLUME OF PRODUCT IN COMMERCE
3 unitsDISTRIBUTION
TN, GA
PRODUCT
Red Blood Cells Leukocytes.CODE
Unit: W117009119797RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA,
Manufacturer: Blood Centers Of The Pacific- Redwood City Center, Redwood City, CA.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
Recovered Plasma,CODE
Unit: 19LR15032
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
Recovered Plasma.CODE
Unit: 53K56871RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD,
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
MD
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Pooled Leukocytes Reduced.
3) Platelets Leukocytes Reduced.
CODE
1) Units: 442FG33587; 42FG33588; 42FG33598; 42FG33602; 42FG33603; 42FG33604; 42FG33606; 42FG33610; 42FG33611; 42FG33613; 42FG33616; 42FG33617; 42FG33618; 42FG33619
2) Units: 11509; 11510; 11526;
3) Units: 42FG33585; 42FG33615
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH,
REASON
Blood products, labeled as volunteer were collected from donors who received monetary payment, were distributed.VOLUME OF PRODUCT IN COMMERCE
19 unitsDISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Units: 42FR48513; 42J86868; 42J86879; 42J86885
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH,
REASON
Blood products, collected using a scales that had unacceptable quality control results, were distributed.VOLUME OF PRODUCT IN COMMERCE
4 unitsDISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Units: 20M57203; 20KK55929; 20LS32166RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT,
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.VOLUME OF PRODUCT IN COMMERCE
3 unitsDISTRIBUTION
UT
PRODUCT Recovered Plasma.
CODE
Units: 22GZ39134 and 22GM60502
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
CA
PRODUCT
Recovered Plasma.CODE
Unit: 24FW31505
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, Louisville, KY.
REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
Recovered Plasma.CODE
Unit: 24KE69016
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY,
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
Recovered Plasma.CODE
Unit: 24GY32502
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY,
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
CA
PRODUCT
Source Plasma.CODE
Unit: AQ030483RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN,
Manufacturer: Plasma Biological Services, Asheville, NC.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
NC
PRODUCT
Recovered Plasma.CODE
Unit: 9648372RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
TX, NJ
PRODUCT
Platelets Pheresis Leukocytes Reduced.CODE
Unit: W045109960002 (split)
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO,
REASON
Platelets, mislabeled as leukoreduced, were distributed.VOLUME OF PRODUCT IN COMMERCE
2 unitsDISTRIBUTION
MO
PRODUCT
Red Blood Cells Leukocytes Reduced.CODE
Unit: W036209407248RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.VOLUME OF PRODUCT IN COMMERCE
1 unitDISTRIBUTION
COWEEK ENDING JULY 17
PRODUCT
Source Plasma.
CODE
Units: 4210366176; 4210365011; 4210363098
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Omaha, NB,
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, IL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 53FM05356
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore,
MD,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: 1508985 (double collection)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN,
Manufacturer: Memorial Blood Centers, Plymouth, MN.
REASON
Blood products, collected from donors whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
PRODUCT
Source Plasma.
CODE
Units: TA2168030, TA2168215, TA2173396, TA2174118
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, New Mexico,
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
England
PRODUCT
Cryoprecipitated AHF, Pooled.
CODE
Units: 8060379, 8057065
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,
REASON
Blood products, manufactured from units of Whole Blood that were overweight,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1677-10;
2) Fresh Frozen Plasma.
CODE
1) Units: 93L30356, 93L32026, 93L35684, 93L38435, 93L21450, 93L22596, 93L23904,
93L25347, 93L27618, 93L30043, 93R01203;
2) Units: 93L38435, 93L22596, 93L30043, 93GC02513
RECALLING FIRM/MANUFACTURER
Mercy Hospital, BB, Springfield, MA,
REASON
Blood products, collected from a donor with a history of hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
MA
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated.
2) Red Blood Cells.
3) Platelets Pooled Leukocytes Reduced.
4) Recovered Plasma.
CODE
1) Unit: W120609383914;
2) Units: W120609207863, W120609206376;
3) Units: W120609384771;
4) Units: W120609206376, W120609207863
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI,
REASON
Blood products, collected from a donor with a history of exposure to and
treatment of rabies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Switzerland, Michigan
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen.
CODE
1) and 2) Unit: 9352826
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA,
REASON
Unit: Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
Source Plasma.
CODE
Unit: 07GNCG2874
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Greensboro, NC,
REASON
Blood product, collected from a donor, whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 7144298
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute –Sylvan N Goldman Center, Oklahoma City, OK,
REASON
Blood product, collected from a donor who was permanently deferred, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
W068510010493 Part A; W068510010493 Part B; W068509018356 Part A; W068509018356
Part B; W068510011107 Part A; W068510011107 Part B
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA,
REASON
Blood products, which were collected from a donor who traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WA, ID
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen within 24 hours (FP24).
CODE
1) and 2) Unit: 19LH30390
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, KY
PRODUCT
Source Plasma.
CODE
Units: 05ANCB0982, 05ANCB0820, 05ANCB0600, 05ANCA9729, 05ANCA9124, 05ANCA8538,
05ANCA8148, 05ANCA7945, 05ANCA7620, 05ANCA7440
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC,
REASON
Blood products, collected from a donor who had previously tested reactive for
Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 1514629
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON
Blood product, with platelet yield below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Red Blood Cells.
CODE
Unit: 1458690
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN,
Manufacturer: Memorial Blood Centers, Plymouth, MN.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 03G50219B1, 03G50219B2
RECALLING FIRM/MANUFACTURER
The American National Red Cross- Southern Region, Douglasville, GA,
REASON
Blood products, collected from a donor for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 4224272 (Bags 1 & 2)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON
Blood products, which were incorrectly tested for viral markers, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets.
3) Fresh Frozen Plasma.
CODE
1), 2), and 3) Units: 2373937
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
REASON
Blood products, collected from a donor who traveled to an area considered at
risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY
PRODUCT
Source Plasma.
CODE
Units: 4100366459, 4100365389, 4100362907, 4100362151, 4100360549, 4100359558,
4100356716, 4100355069, 4100353523, 4100352574, 4100350951, 4100350183,
4100346510, 4100345847, 4100341596, 4100335593
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Kansas City, MO
REASON
Blood products, collected from a donor who did not receive a complete physical
examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
IL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 1512573
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON
Blood components, processed and refrigerated more than 8 hours after
collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 1526427
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated January 6,
REASON
Blood components, processed and refrigerated more than 8 hours after
collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Source Plasma.
CODE
Units: 0460102740; 0460100226; 0460100384; 0460101384; 0460101896; 0460102564;
0460103203; 0460103382; 0460107655; 0460107844; 0460108366; 0460108604
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX,
REASON
Blood products, collected from a donor who received a tattoo within 12 months of
donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Spain, CA
PRODUCT
Platelets Pheresis Leukocytes Reduced. R
CODE
Units: 09GP46296; 09GP46296
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB
REASON
Blood products, labeled as leukoreduced, but which did not meet the criteria for
leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NB
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W038110023096
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL,
REASON
Blood product, collected from a donor possibly at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: W05209175282H; W035209175282H; W035208164148K; W035208164148K; 4030978;
4030978
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 27LC76782
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 24KQ80505
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Louisville, KY,
Manufacturer: American National Red Cross Blood Services, Louisville, KY.
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
PRODUCT
Source Plasma.
CODE
Unit: 4020062851
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma Inc., Boca Raton, OH,
Manufacturer: CSL Plasma Inc. Akron, OH.
REASON
Blood product, collected from a donor whose scheduled physical exam was
incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W120609414777
RECALLING FIRM/MANUFACTURER
Michigan Blood, Traverse City, MI.
REASON
Blood product, collected from a donor who traveled to an area considered endemic
for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 53LL00315
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore,
MD,
REASON
Blood product, incorrectly labeled as negative for the Jk (a) red cell antigen,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W071209004131
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN,
REASON
Blood product, collected from a donor who traveled to an area considered endemic
for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
PRODUCT
Source Plasma.
CODE
Unit: 08CWYF0296
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Cheyenne, WY
REASON
Blood
product, collected from a donor for whom donor suitability was not adequately
determined, was distributed. VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Units: 017FQ18649; 017FQ18649; 017FQ18649;
2) Units: 017FQ18637; 017FQ18637; 017FQ18655; 017FQ18655; 017FQ18655
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN,
REASON
Blood products, which did not meet the acceptable product specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MN
PRODUCT
1) Plasma Frozen with 24 hours (FP24).
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) 03S46682
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA,
REASON
Blood products, collected from a donor for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets.
3) Fresh Frozen Plasma.
4) Source Leukocytes.
CODE
1), 2), 3), 4) Unit: W044608300770
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood products, collected from a donor with a history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, NJ
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 09FC37692 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB,
REASON
Blood products, collected in a manner that may have compromised the sterility of
the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NB
PRODUCT
Source Plasma.
CODE
Units: 6130023335, 6130023031, 6130024323
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc, Zlb Plasma, Duluth, MN,
REASON
Blood products, collected from donors who were previously deferred for high risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Germany
PRODUCT
1) Fresh Frozen Plasma.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 2426762;
2) Units: 2426762, 2917746
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA,
REASON
Blood products, collected from a donor who was previously deferred for testing
positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA, Austria
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 004J19803, 004KH29553, 004KK80768, 004KM20958
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NH, VT, NY, MA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Cryoprecipitated AHF.
CODE
1) and 2) Unit: 04V59585
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA,
Manufacturer: ANRC ARC Blood Services, New England Region, Danvers, MA.
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA, ME
PRODUCT
Recovered Plasma.
CODE
Unit: 53FM05356
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore,
MD,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 308438105
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: United Blood Services, Bismarck, ND.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: W042408019401M, W042408019407A, W0424080194272, W042408019430C,
W0424080194336, W042408019497B, W042408019510C, W0424080194088
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc, Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Rapid City, SD.
REASON
Apheresis red cells, manufactured using Lactated Ringers Solution instead of
Saline as the volume replacement solution for the donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units (Double Collections)
DISTRIBUTION
CA, TX, MI, SD, NH
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 17FF31040, 17FF31132, 17FF31128, 17FF28548, 17FF28377, 17FF28544,
17FF30792
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Saint Paul, MN,
REASON
Blood products, which may have exceeded the maximum limit for hematocrit, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN
PRODUCT
Source Plasma.
CODE
Units: 09OUTD7444; 07OUTE7478
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Ogden, UT,
REASON
Blood products, collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
Source Leukocytes.
CODE
Unit: W044609512182
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
PRODUCT
Source Plasma.
CODE
Units: AQ030479; AQ030602
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Ashville, NC
REASON
Blood products, which were collected from a donor in which donor suitability was
not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030651
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN,
Manufacturer: Plasma Biological Services, Ashville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030628
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Ashville, NC,
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030444
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN,
Manufacturer: Plasma Biological Services, Ashville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: GJ07522; GJ07526; GW32408; GW32422; GW32425; KL20752; KL20755; LC94828;
LJ61865; KL20740
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood products, lacking assurance of having been maintained at an acceptable
temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
WI
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: 1507716
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON
Blood product, lacking assurance of having been maintained at an acceptable
temperature during shipping, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
PRODUCT
Recovered Plasma.
CODE
Unit: 27LC76782
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: W036908259025 ( part 1 and 2)
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE,
REASON
Blood products, with an unacceptably low red cell recovery rate, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD
PRODUCT
1) Red Blood Cells.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: W065608014498
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ,
REASON
Blood products, collected from a donor who received the shingles vaccine, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
PRODUCT
Platelets.
CODE
Unit: W044608343956
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood product, for which documentation of the collection time was discrepant,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
Recovered Plasma.
CODE
Unit: 2917746
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA,
REASON
Blood product, collected from a donor who was previously deferred for testing
positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
PRODUCT
Recovered Plasma.
CODE
Units: 004J19803, 004KH29553, 004KK80768, 004KM20958
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: W065610003177;
2) Unit: W065610010299
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ,
REASON
Blood products, which were incorrectly labeled as negative for unexpected
antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
PRODUCT
Recovered Plasma.
CODE
Unit: 004Y18860
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA,
Manufacturer: ANRC ARC Blood Services, New England Region, Danvers, MA.
REASON
Blood product, collected from donors for whom donor suitability was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
WEEK ENDING JULY 10
PRODUCT
Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72J389876
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON
Blood product, with platelet count below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
PRODUCT
Red Blood Cells,
CODE
Unit: 3157921
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON
Blood product, collected from a donor taking the medication Proscar, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: W068509030122;
2) Unit: W068509353543
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA,
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
WA, ID
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 2567416
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
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
KY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 20M58459
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 2470663
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
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
KY
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 2489635,
2) Units: 2430587,2434419, 2489635, 2512191
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
PRODUCT
Red Blood Cells.
CODE
Unit: W020009100984
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Bb, Bethesda, MD,
REASON
Blood product, collected from a donor who reported travel to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
District of Columbia
PRODUCT
Red Blood Cells.
CODE
Unit: W020408002137
RECALLING FIRM/MANUFACTURER
Naval Hospital, Camp Lejeune, NC,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Red Blood Cells.
CODE
Units: 4818826, 4821498
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Bb, Bethesda, MD
REASON
Blood products, collected from a donor who traveled to an HIV Group O risk area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Afghanistan, Bahrain
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W03509005931
RECALLING FIRM/MANUFACTURER
Community Blood Center dba Community Tissue Services, Dayton, OH,
REASON
Blood product, collected from a donor who was previously deferred, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Source Plasma.
CODE
Units: AU0049555; AU0048602; AU0048243; AU0049918
RECALLING FIRM/MANUFACTURER
DCI Biologicals Austin, LLC, Austin, TX,
REASON
Blood products, collected from a donor whose physical exam was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: 06GS20840
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Source Plasma.
CODE
Units: SS0035343; SS0039872; SS0059043
RECALLING FIRM/MANUFACTURER
DCI Biologicals San Marcos, LLC, San Marcos, TX,
REASON
Blood products, collected from a donor who received a body piercing within 12
months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: W043210001777; W043210001777
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood products, with unacceptably high platelet yields, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 024FH67277; 024FH67277
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO
REASON
Blood products, processed from an apheresis unit with platelet yield below the
specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 007GJ36609
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tucson, AZ
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: W0407099030265
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN,
REASON
Blood product, with platelet yield below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: W0419090486672
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV,
REASON
Blood product, with insufficient plasma to support the platelet concentration,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: 2907576
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH,
REASON
Blood product, collected from a donor who reported travel to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
PRODUCT
Platelets Leukocytes Reduced.
CODE
Units: 6735905; 0817396
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,
REASON
Blood products, which may have been stored under unacceptable temperature, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: W086509002348, W086309005244, W086209006280, W086209009277,
W086109006758, W085009002221, W084909004377, W084609002631, W084709000910,
W086209006293, W085009002222, W085909006739, W086009006304, W086309005193,
W086909000848, W085609002200, W085809004665, W086509002364, W087009002641,
W084609002630, W085409001195, W085609002203, W086109006735, W086509002385,
W084109001855, W086009006374
RECALLING FIRM/MANUFACTURER
ITXM Clinical Services, Pittsburgh, PA,
REASON
Blood products, leukodepleted greater than five days after collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
PA
PRODUCT
Whole Blood.
CODE
Unit: 0822633; 0822638; 0822670; 0822708
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,
REASON
Blood products, collected in 500 mL bags but labeled as 450 mL, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
PRODUCT
Liquid Plasma.
CODE
Unit: W020408002137
RECALLING FIRM/MANUFACTURER
Naval Hospital, Camp Lejeune, NC,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Unit: W221609400615
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX,
REASON
Blood products, collected from a donor who received a bone graft within one year
of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX
PRODUCT
Recovered Plasma.
CODE
Unit: 007GJ36609
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tucson, AZ,
REASON
Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Source Plasma.
CODE
Unit: AQ030475
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC,
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Memphis, TN,
Manufacturer: Plasma Biological Services, Asheville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030654
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN,
Manufacturer: Plasma Biological Services, Asheville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Source Plasma.
CODE
Unit: AQ030467
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN,
Manufacturer: Plasma Biological Services, Asheville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: 7164980, 7131248, 7131274, 7164847, 7131800, 7131665, 7131673, 7131538,
7131348, 7131712
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON
Blood products, for which Quality Control was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
TX
PRODUCT
Source Plasma.
CODE
Unit: 05ANCA1760
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Memphis, TN,
Manufacturer: Plasma Biological Services, Asheville, NC.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
PRODUCT
Platelet Pheresis Leukocyte Reduced-7 day.
CODE
Unit: 4761440
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL
REASON
Blood product, with positive bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Fresh Frozen Plasma (Apheresis).
CODE
Units: KF41050 Part B; KF41050 Part C
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood products, which may have reached an unacceptable temperature during
storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
WEEK ENDING JULY 3
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: 017GR52399
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Saint 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 MN
PRODUCT Source
Plasma for further manufacture.
CODE
Units: 2040055458, 2040053823, 2040052644
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Columbus, OH,
REASON Blood products, collected from a donor whose scheduled
physical exam was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION NC
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Plasma Frozen.
CODE
1) and 2) Unit: 35FX31325
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Roanoke, VA
REASON Blood products, collected from a donor whose suitability
to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WV, VA
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE Unit: 72M912651
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT
1) Platelets Leukocytes Reduced. ;
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 16GW65754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH.
REASON Blood products, which were collected from a donor who
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Leukocytes Reduced.
CODE
1) and 2) Unit: 42K03922
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malarial, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Source
Plasma. CODE
Units: TA0009385, TA0009509, TA0009802, TA0009915, TA0010386, TA0010622,
TA0009110
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana, LLC, Gallup, NM,
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR.
REASON Blood products, collected from a donor who received a
tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION NC, Austria
PRODUCT
1) Red Blood Cells.
2) Fresh Frozen Plasma. CODE
1) and 2) Unit: 2410916
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON Blood products, collected from a donor taking the
medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Source
Plasma. CODE
Units: TA2027243; TA2027466; TA2027967; TA2028589; TA2029646; TA2034008;
TA2034254
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR
REASON Blood products, collected from a donor who failed to
answer questions regarding risk for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION NC
PRODUCT Source
Plasma. CODE
Units: 392024241, 392024888, 392024736, 392024460, 392023913, 392023630,
392022516, 392022315, 392021477, 392019895, 392019018, 392018776, 392017949,
392017800, 392016873, 392015873, 392015695, 392021266, 392014979, 392014796,
392014513, 392014318, 392014004, 392013315, 392011484, 392011296, 392010995,
392010791, 392011918, 392011746, 392010035, 392009822, 392009567, 392009386,
392009013, 392008696, 392007424, 392007190, 392006837, 392006655, 392003751,
392003669, I56018212, I56018076, I56017991, I56016744, I56016629, I56016549,
I56016464, I56016382, I56016060, I56015712, I56015693, I56015156, I56015051,
I56014305, I56014146, I56013685, I56013373, I56013201, I56012705, I56012233,
I56008497 and I56008467
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park,
NC, Manufacturer: Talecris Plasma Resources, Inc., Rockford, IL.
REASON Blood products, collected from a donor who was
previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 64 units
DISTRIBUTION NC, Austria
PRODUCT Recovered
Plasma.
CODE Unit: 4164109
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON Blood product, collected from a donor at increased risk
for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria
PRODUCT Red Blood
Cells (Apheresis) Leukocytes Reduced.
CODE
Units: 53LK15606; 53LK15607; 53LK15607; 53LK15606
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore,
MD,
REASON Blood products, not tested for hemoglobin content as
part of the collection equipment validation process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION MD
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated.
CODE Unit: 8037059
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON Blood product, with platelet yield below the specified
minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Units: 8206247 Part 1; 8206247 Part 2; 8205841 Part 1; 8205841 Part 2; 8205513
Part 1; 8205513 Part 2
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION OH
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Unit: 8115549;
2) Units: 8115549; 8115907; 8116095
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, 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 4 units
DISTRIBUTION OH
PRODUCT Fresh
Frozen Plasma.
CODE Unit: W010407004016
RECALLING FIRM/MANUFACTURER
Department of the Army, Brooke Army Medical Center, Fort Sam, Houston, TX
REASON Blood product, collected from a donor whose risk for
variant Creutzfeldt-Jakob Disease (vCJD) was undetermined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: 12C84554
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC,.
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC, AL
PRODUCT Red Blood
Cells. CODE Unit: W121609542219
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC,
REASON Blood product, collected from a donor who traveled to an
area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: W0415100010056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Lubbock Center, Lubbock, TX
Manufacturer: Blood Systems, Inc., San Angelo, TX.
REASON Blood product, collected from a donor who was at risk
for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Units: W041009231481L, W0410100184536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., dba United Blood Services,
Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., dba United Blood Services, Chandler,
AZ.
REASON Blood products, for which quality control testing was
not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N220724
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N333896
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N093024
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT
1) Fresh Frozen Plasma.
2)
Red Blood Cells.
3) Platelets.
CODE
1) Unit: 1030796;
2) and 3) Unit: 1030796, 0914211;
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON Blood products, collected from a donor for whom donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION VA, MN
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Unit: W035209185910Z
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX,.
REASON Blood products, collected from a donor who received a
blood transfusion within a year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated.
2) Fresh Frozen Plasma. Recall # B-1598-10;
3) Red Blood Cells.
CODE
1) Unit: W120609383914;
2) and 3) Unit: W120609207864
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI,
REASON Blood products, collected from a donor with a history of
exposure to and treatment for rabies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MI
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Red Blood Cells.
3) Platelets Pooled Leukocytes Reduced.
CODE
1) Unit: W120609270227;
2) Unit: W120609202742;
3) Units: W120609380204, W120609381649
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI,
REASON Blood products, collected from a donor who resided in an
area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION MI
PRODUCT
1) Red Blood Cells.
2) Fresh Frozen Plasma.
3)
Recovered Plasma.
CODE
1) and 2) Unit: W035409010150;
3) Unit: 3167933
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Austria, OH
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: W117010154265 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA,
REASON Blood products, which were not quarantined after
receiving post donation information concerning an illness following donation,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Source
Plasma. CODE Unit: 08NWVB4925
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Clarksburg, WV
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Source
Plasma. CODE
Unit: 09DIAM6213
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Dubuque, IA,.
REASON Blood product, collected from a donor who did not have a
complete physical exam prior to donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE CA
DISTRIBUTION 1 unit
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: W117009140843
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Platelet
Pheresis Leukocytes Reduced.
CODE
Unit: W035410004669 (7 units)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
REASON Blood products, labeled with an extended expiration
date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION OH
PRODUCT
1) Red Blood Cells.
2) Fresh Frozen Plasma. CODE
1) and 2) Unit: 72M447306
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA,
REASON Blood products, collected from a donor who was
previously deferred for receiving a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Cryoprecipitated AHF, Pooled.
CODE
1) Unit: W038110054274;
2) Unit: W038110982894
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers – Lake Park, Lake Park, FL,
REASON Blood products, manufactured from units of Whole Blood
that were overweight, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Units: W038109032908, 7375108
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Inc., Melbourne, FL
Manufacturer: Florida’s Blood Centers, Inc., Rockledge, FL.
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Unit: LC87524;
2) Unit: LC88580
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI,
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WI
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: W036309160505
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI,
Manufacturer: BloodCenter of Wisconsin, Inc., Racine, WI.
REASON
Blood product, collected from a donor who took aspirin within 48 hours of
donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: 29KF48780
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 2495919
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Units: 2466096, 2393080B, 2393080A, 2466096A
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION KY
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: W045010026325
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KS
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Units: 2435190, 2534284;
2) Units: 2435190, 2495268, 2534284
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION KY
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: W041609045435R
RECALLING FIRM/MANUFACTURER
Blood Systems Inc,/dba United Blood Services, Meridian, MS,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MS
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: 003GL94680
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N569412
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., East Alabama Region, Opelika, AL
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced.
CODE
Unit: 72N430021
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Dunwoody, GA,
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
1) Red
Blood Cells Leukocytes Reduced.
2) Platelets Pooled Leukocytes Reduced.
CODE
1) Unit: 0824440;
2) Unit: 1016908
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,.
REASON Blood products, collected from a donor for whom donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Red
Blood Cells Leukocytes Reduced.
CODE
Unit: W036209625278
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO,
REASON Blood product, which was incorrectly labeled as negative
for the K red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: 03LE51675
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: GL01133
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc, Milwaukee, WI,
REASON Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: 2880059
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH,
REASON Blood product, which did not have a platelet count
performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH
PRODUCT
1) Platelets Pooled Leukocytes Reduced.
2) Red Blood Cells.
CODE
1) Unit: 1010007;
2) Unit: 6748176
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH,
REASON Blood product, collected from a donor who was at risk
for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Recovered
Plasma.
CODE
Unit: 12C84554
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC, AL
PRODUCT Red Blood
Cells Leukocytes Reduced.
CODE
Unit: W149509205472
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA,
REASON Blood product, manufactured without the additive
solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Recovered
Plasma.
CODE
Unit: 0914211
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT Recovered
Plasma.
CODE
Unit: 29KF48780
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Recovered
Plasma.
CODE
Unit: W041609045435R
RECALLING FIRM/MANUFACTURER
Blood Systems Inc,/dba United Blood Services, Meridian, MS,
REASON Blood product, collected from a donor for whom donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland