JANUARY 2009
WEEK ENDING JANUARY 3
PRODUCT
Platelets Pheresis Leukocytes Reduced, CODE Unit: 1411995
RECALLING FIRM/MANUFACTURER Community Blood Council of
New Jersey, Inc., Trenton , NJ ,
REASON Blood product, which tested
positive for Cytomegalovirus (CMV), but was labeled as negative for CMV, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT
Red Blood Cells Leukocytes Reduced, CODE Unit: 9061630
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford , TX ,
REASON
Blood product, which was collected
from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 4046579 (part 1 and part 2)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford ,
TX
REASON Blood product,
which was collected from a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX
PRODUCT
Platelets Pheresis Leukocytes Reduced, CODE Unit: 72H373764
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood
Centers, Inc., Gainesville , FL ,
Manufacturer: LifeSouth Community Blood Centers, Inc., Mobile , 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: 72F261562
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood
Centers, Inc., Gainesville , FL ,
Manufacturer: LifeSouth Community Blood Centers, Inc., Brooksville, FL.
REASON
Blood product,
with a low platelet count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT
Platelets Pheresis Leukocytes Reduced, CODE Unit: 72F682645
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville , FL
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE1 unit
DISTRIBUTION FL
PRODUCT
Red Blood Cells Leukocytes Reduced, CODE Units: W11916, W08504
RECALLING
FIRM/MANUFACTURER Northern Illinois Blood Bank dba Rock River
Valley BC, Rockford, IL,
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 IL and NC
PRODUCT Red Blood Cells Leukocytes Reduced, CODE
Unit: 6614642
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc.,
Lakeland , FL ,.
REASON Blood product, which was labeled with
an incorrect expiration date and product code, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells
Leukocytes Reduced,
CODE
a) Units:
2541733, 2541736, 2541737, 2541738, 2541741, 2541758, 2541759;
b)
Units : 2541731, 2541732, 2541733, 2541734, 2541735, 2541736, 2541737, 2541738,
2541739, 2541740, 2541742, 2541743, 2541744, 2541745, 2541746, 2541747, 2541748,
2541749, 2541750, 2541753, 2541754, 2541755, 2541756, 2541757, 2541758, 2541759,
2541760, 2541761, 2541762, 2541763, 2541764, 2541765, 2541767, 2541768
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville , TN
,
REASON Blood products,
labeled with an extended expiration date, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION TN and KY
PRODUCT
Red Blood Cells Leukocytes Reduced, CODE Units: 4458387, 4458421,
4458445
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers , Baton Rouge , LA ,
REASON Blood products, collected
from an unsuitable donor due to a history of hemochromatosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION LA
WEEK ENDING JANUARY 10
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, b)
Platelets Pheresis Leukocytes Reduced,
c) Fresh Frozen
Plasma,
CODE
a) Units: 170795192,
170795042, 170793622 (Part 1 and 2), 170792733, 170789051, 170790984, 176531970,
176533855;
b) Units: 170792733 (Part 1 and 2);
c) Units: 170790984,
176531970
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Mcallen, TX,
REASON Blood products, collected
from donors, whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION TX
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit: KT60602
RECALLING FIRM/MANUFACTURER Inova Health Care Services,
Blood Donor Services, Sterling, VA,
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 MD,
VA
PRODUCT
a)
Medtronic MEGELLAN Autologous Platelet Separator Disposables Kit, REF Catalog
Number 9320100, MDK300, MDK30066. Sterile. Model 9320100, MDK300, MDK30066,
COS310 (MDK300). The Medtronic Magellan Autologous Platelet Separator
Disposables Kit consists of sterile fluid pathway single-patient-use components
necessary for each platelet separation procedure with the Magellan Autologous
Platelet Separator Instrument
b) Medtronic Magellan Basic Platelet Separator kit, Catalog Number MDK305, MDK30566 sterile, Model MDK305, MDK30566, BOS350 (MDK305),
c) Arteriocyte Medical Systems MAGELLAN® Autologus Platelet Separator Disposables Kit, Catalog Number AMS300 Sterile, Model AMS300ID,
d) Arteriocyte Medical Systems MAGELLAN Basic Platelet Separator Kit, Catalog
Number AMS305, AMS301 sterile, Model AMS305ID, BOS360, BOS370, COS320, COS330,
CODE
a) Lot # 6330342 6725441 6799124
6826348 6826356 6932845 7013496 7013517 7075241 7075259 7123759 7189715 7259411
7259429 506004274 506006002; Lot # 2955994 3047488 3122644 3242494 3453582
3843151 3919549 3972059 3972251 3972340 4053812 4109118 4164344 4196768 4847532
4847541 4913675 4913683 4913691 4979771 4979797 5032693 5090893 5090914 5090949
5245488 5245496 5528091 5535400 5535418 5625991 5626011 5626029 6019423 6109672
6134940 6134966 6200185 6258820 6258862 6258889 6405367 6405404 6405501 6444489
6517035 6589522 6666701 6666735 6725432 6792352 6792379 6826364 7013509 7123724
7123732 505000841 505002283 505002284 505003953 505005447 505006910 506001662
506003184 506004729 506006000 507000675 507002534; Lot # 9285049 9796818 9796851
9816840 9816843 9816845 9851563 9853140 9860205 9331771 7193706 7311469 7311485
7434258 7434371 7446380 7446398 7539666 7539674 7599319 7599343 7721960 7721978
7740714 7740722 7740731 7856717 7871562 7886781 7886799 7886801 9260351 9377681
9377701 9412052 9682538 9704119 9704135 9742300 9796771 9796797 9796826 9796834
9806150 9806999 9807498 9808044 9808158 9808321 9816837 9826714 9830191 9830194
9830198 9830201 9837280 9837282 9837284 9837286 9837288 9853127 9860207 9860208
9860216 9868038 9979216; Lot # 579154 586641 613879 634164 662962 759324 774619
80052696 80054317 80056919 80063536 80064479 80064978 80065803 80065958 80066436
80066935 80067611 80068447 80069230 80069876 80070642 80070826 80071390 80072061
80072112;
b) Lot # 3306056 3726886 4053821 4078112 4078139 4799235 5032677 5163984 3047541 3122652 3228588 3242507 3726923 3726966 3919426 3919493 3972155 3972315 4109193 4799227 5032685 5163992 5218931 6015844 505000842 505000843 505002285 505003954 505006911 506001664 506003185 506004730 506006001 507000676 507002535; Lot # 9285065 9377672 9796800 9816836 9816842 9331762 5164004 5164012 5291441 5291468 5311406 5311414 5425745 5535426 5670054 5670062 5670071 5713026 5713034 5713042 5775964 5775981 5775999 6015828 6016011 6019440 6093332 6200134 6200151 6200169 7075216 7123741 7189336 7189387 7311493 7311506 7708271 7708280 7740749 7856709 7871554 9102290 9242031 9331818 9377699 9405979 9682546 9682562 9704127 9704143 9704151 9796789 9796842 9796877 9808322 9815824 9816834 9816835 9816838 9816844 9830193 9830195 9830199 9830202 9837281 9837283 9837285 9837287 9868043 9949021 9951553 9979215; Lot # 588798 613000 656529 691316 701013 713511 739543 743342 80052330 80052667 80060346 80061248 80068105 80069489 80069627 80070004 80070144 80071229;
c) Lot # 9955827 9983369 9991227;
d) Lot # 9951547 9955831 9983372; Lot # 80069668; Lot # 629430 15349921
15405231; Lot # 597114 665618 80052558 80053141 80067369; Lot # 611963 701885
733424 80069624
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Medtronic Cardiovascular Revascularization and Surgical Therap, Brooklyn
Park, MN,
Manufacturer: Medtronic Mexico,
S. De R. L. De C. V., Tijuana, Baja California, Mexico.
REASON
Luer-Lok syringes, which lack assurance
of sterility, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
77,920 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Platelets Pheresis Irradiated,
b) Platelets Pheresis,
CODE
a) and b) Unit:
9935527
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood products, labeled leukoreduced without the assurance that they met the
criteria for leukoreduced products, were distributed.
VOLUME OF
PRODUCT IN COMMERCE
2 units
DISTRIBUTION FL
PRODUCT Administration Components for I.V. Infusion packaged with Mononine
(Coagulation Factor IX, Human); The Administration Components for I.V. Infusion
pack, labeled sterile, contains 1 winged infusion set of I.V. infusion, one 5
micron filter spike and 1 transfer needle, REF 7C5009; The Mononine, NDC
0053-7668-04,
CODE Lot 60970417;
packaged with Mononine lots J22306, J22506, J22607, J22707 and
J23208
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Aventis Behring L.L.C., Bradley, IL, Manufacturer: B. Braun Medical, Inc., Allentown, PA.
REASON Sterile component
packs contained in the Mononine cartons; which may have an incomplete seal
between the soft blister pack and the package cover compromising the sterility
of the components, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
2,289 packs
DISTRIBUTION AZ, CA,
FL, GA, ID, IL, IN, IA, KS, KY, MA, MI, MO, NJ, NC, ND, PA, TN, TX,
WA
PRODUCT Platelets,
CODE
Unit:
4304995
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
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 TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 4025834
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON
Blood product, collected from a
donor who reported living in a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION TX
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE Units: 50KW04277 (2
units)
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Toledo, OH,
REASON Blood products, collected from a donor
who visited a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE
2 units
DISTRIBUTION OH
PRODUCT
a)
Red Blood Cells (Apheresis) Leukocytes Reduced, b) Red
Blood Cells Leukocytes Reduced Irradiated, CODE
a) Units: 9043160 (2 units);
b) Unit:
7932252
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood products, collected from a donor who reported travel to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
3 units
DISTRIBUTION TX
PRODUCT Platelets,
CODE
Unit:
4246417
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
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 TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 9085301
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON
Blood product, collected from a donor
who travel to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TX
PRODUCT Cornea,
CODE
Units: 04830801,
04830802
RECALLING FIRM/MANUFACTURER Northeast PA Lions
Eye Bank, Inc., Allentown, PA,
REASON Human tissue for
transplantation, collected from a donor whose blood sample for testing, was
hemodiluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION PA
PRODUCT
a)
Red Blood Cells,
b) Platelets,
CODE a) and b) Unit:
3886360
RECALLING FIRM/MANUFACTURER New York Blood
Center, Inc., Long Island City, NY
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 NY
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: 71X265425
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
CODE
Unit:
2202646
RECALLING FIRM/MANUFACTURER Suncoast Communities
Blood Bank, Inc., Sarasota, FL
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 FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Units: 7714166 Part 1; 7714166 Part 2
;7714029 Part 1; 7714029 Part 2
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota,
FL
REASON Blood products, which were collected from a donor who traveled to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT
IN COMMERCE
4 units
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: 71X441751
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Brooksville, FL,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: 72H264050
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood
Centers, Inc., Gainesville, FL,
Manufacturer:
LifeSouth Community Blood Centers, Inc., Brooksville, FL.
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: 72 E67639X
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Source Plasma,
CODE
Units:
363014503 and 363009807
RECALLING FIRM/MANUFACTURER Talecris Plasma Resources Inc., Fort Worth,
TX
REASON Blood products, which were collected from a donor who was deferred due to
risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel,
were distributed
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION NC
PRODUCT Red
Blood Cells Leukocytes Reduced, CODE Unit: 9844028
RECALLING FIRM/MANUFACTURER
LifeShare
Blood Centers, Lake Charles, LA,
REASON Blood product, collected from
a donor with an elevated body temperature, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TX
PRODUCT
Red Blood Cells Leukocytes Reduced Washed,
CODE
Unit: 40LZ21000
RECALLING
FIRM/MANUFACTURER American National Red Cross HOA Blood Services
Region, Peoria, IL,
REASON Blood product, which was washed with an
incorrect saline solution, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IL
WEEK ENDING JANUARY 17
PRODUCT Red Blood Cells,
CODE
Units: 4402032, 4402034,
4402031
RECALLING FIRM/MANUFACTURER Suncoast Communities
Blood Bank, Inc., Sarasota, FL,
REASON Blood
products, collected from donors whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION FL
PRODUCT Red Blood Cells,
CODE
Unit: 6233907
RECALLING
FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL,
REASON
Blood product, collected from a donor in
which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells,
Leukocytes Reduced,
c) Platelets Leukocytes Reduced,
CODE
a) Units: 019GR58259, 019GR58261;
b) Units: 019GR58244, 019GR58247, 019GR58248, 019GR58249, 019GR58250, 019GR58251, 019GR58252, 019GR58253, 019GR58254, 019GR58257, 019GR58261;
c) Units: 019GR58244, 019GR58248, 019GR58249, 019GR58251, 019GR58252,
019GR58253, 019GR58261, 019GR58263
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN,
REASON Blood products, collected in a manner
that may have compromised the sterility of the units, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
21
units
DISTRIBUTION TN,
KY
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: 123769835
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ, Manufacturer: Blood Systems, Inc.,
Albuquerque, NM.
REASON Blood product, which was possibly
contaminated with Propionibacterium species, was distributed.
VOLUME
OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION NM
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE Unit: 019FZ35332 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services Tennessee Valley Region, Nashville, TN,
REASON
Blood products, collected using
apheresis kits that had exceeded the acceptable time period for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION TN
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Units: 5425275, Part A and
B
RECALLING FIRM/MANUFACTURER The Blood Center of New
Jersey, East Orange, NJ
REASON Blood products, which were possibly
contaminated with Peptostreptococcus Asaccharrolyticusi, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION NJ
PRODUCT Recovered Plasma,
CODE
Units: 4402032, 4402034,
4402031
RECALLING FIRM/MANUFACTURER Suncoast Communities
Blood Bank, Inc., Sarasota, FL,
REASON Blood
products, collected from donors whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
3
units
DISTRIBUTION NY
PRODUCT Red Blood Cells,
CODE
Unit: W050908009749
RECALLING
FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA,
REASON
Blood product, labeled as negative for
red cell antibodies, but collected from a donor with a history of testing
positive for red cell antibodies, was distributed.
VOLUME OF PRODUCT
IN COMMERCE
1
unit
DISTRIBUTION PA
PRODUCT Recovered Plasma,
CODE
Unit: 6233907
RECALLING
FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL,
REASON
Blood product, collected from a donor in
which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION Switzerland
PRODUCT Platelets
Pheresis Leukocytes Reduced, CODE Unit: 123796881
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ, Manufacturer: Blood Systems, Inc.,
Albuquerque, NM.
REASON Blood product, which was possibly
contaminated with Diptheroid bacilli, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1
unit
DISTRIBUTION NM
WEEK ENDING JANUARY 24
PRODUCT
a) Recovered Plasma,
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b)
Recall #: 9621705
RECALLING FIRM/MANUFACTURER LifeShare
Blood Centers, Baton Rouge, LA,
REASON Blood products, collected from a donor
who had sexual contact with a person who was born in an HIV Group O risk area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION AR,
Switzerland
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE Unit: FQ87827
RECALLING
FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by
facsimile on December 30, 2005. Firm initiated recall is
complete.
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 WI\
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Units: GN23880, GN24950
RECALLING
FIRM/MANUFACTURER
Blood Center 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 Recovered Plasma,
CODE
Unit: LE79752
RECALLING
FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI,
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 Red Blood Cells Leukocytes Reduced,
CODE Unit: 026FW11484
RECALLING
FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL,
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 FL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 026GG14372
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: The American National
Red Cross, Mobile, AL
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
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 4036137
RECALLING
FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood product, which was collected from
a donor who traveled to malarial endemic areas, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION TX
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 9457027
RECALLING
FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc.,
Jackson, TN,
REASON Blood product, which tested positive for
red cell antibodies, but was labeled as negative for red cell antibodies, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION TN
PRODUCT Recovered Plasma,
CODE
Unit: 026FW11484
RECALLING
FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL,
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 Israel
PRODUCT Recovered Plasma,
CODE
Unit: 026GG14372
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: The American National
Red Cross, Mobile, AL.
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
a) Platelets Pheresis Leukocytes Reduced, Irradiated,
b) Platelets Pheresis Leukocytes Reduced,
CODE
a) Units: 026KP28295 Part 1, 026KP28295
Part 2, 026KP28289;
b) Unit: 026KP28304
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross
Blood Services, Montgomery, AL.
REASON Blood products, collected using an
expired blood collection set, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
4 units
DISTRIBUTION AL
WEEK ENDING JANUARY 31
PRODUCT Platelets,
CODE
Unit:
7950264
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, 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 TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 027GW30654
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 Source Plasma,
CODE
Units: 363016138, 363016408, 363016950,
363017201, 363017711, 363018249, 363018667, 363018975, 363019374, 363019716,
363021115, 363021459, 363020357, 363020746, 363021670, 363021970, 363022839,
363023175, 363028486, 363028681, 363029547, 363030066,
363030604
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Fort Worth, TX,
REASON Blood products, collected from a
donor whose physical exam was incomplete, were distributed.
VOLUME OF
PRODUCT IN COMMERCE
23
units
DISTRIBUTION NC
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated,
CODE
Unit: W071208005020
RECALLING
FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN,
REASON
Blood product, labeled leukoreduced, but
which had not undergone leukoreduction, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1
unit
DISTRIBUTION TN
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: W036208187080
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood product, collected from a donor
who tested repeat reactive for STS (Serum test for Syphlis) with a positive
confirmatory result, was distributed.
VOLUME OF PRODUCT IN
COMMERCE
1
unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Platelets,
CODE a) and b) Unit:
9569532
RECALLING FIRM/MANUFACTURER
Carter BloodCare,
Bedford, TX,
REASON Blood products,
collected from a donor who traveled to a malaria endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION TX,
MI
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit:
4045710
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood product, which was collected from
a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Cryoprecipitated AHF,
CODE a) and b)
Unit: 6649661
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
TX
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 TX
PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated,
CODE
Units: 16KK23799
(split product)
RECALLING FIRM/MANUFACTURER American Red
Cross Blood Services, Columbus, OH,
REASON Blood
products, labeled leukoreduced without the assurance that they met the criteria
for leukoreduced products, were distributed
VOLUME OF PRODUCT IN
COMMERCE
2
units
DISTRIBUTION OH
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Units: 7725279;
7724935
RECALLING FIRM/MANUFACTURER Suncoast Communities
Blood Bank, Inc., Sarasota, FL,
REASON Blood products, labeled
leukoreduced without the assurance that they met the criteria for leukoreduced
products, were distributed.
VOLUME OF PRODUCT IN
COMMERCE
2
units
DISTRIBUTION FL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 026KG0809
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: American Red Cross Blood Services,
Montgomery, AL.
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
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 041LX50807
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: American Red Cross Blood Services, Alabama
Region, Huntsville, AL.
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
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 026FK65286
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: The American National Red Cross,
Mobile, AL.
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
PRODUCT Blood Cells Leukocytes Reduced,
CODE Units: 019GV27116; 019LJ29154
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
PRODUCT
a) Platelets Leukocytes Reduced Irradiated,
b) Red Blood Cells Leukocytes Reduced,
c) Fresh
Frozen Plasma,
CODE a), b), and c)
Unit: 19LT35959
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
3
units
DISTRIBUTION TN,
KY
PRODUCT
a) Red Blood Cells,
b) Platelets,
CODE
a) and b) Unit:
8801052
RECALLING FIRM/MANUFACTURER
Suncoast Communities
Blood Bank, Inc., Sarasota, FL,
REASON Blood products,
collected from a donor who reported travel to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION FL
PRODUCT Recovered Plasma,
CODE
Unit: 027GW30654
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 Leukocytes Reduced,
CODE Unit: 125946250
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON
Blood product, collected from
a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1
unit
DISTRIBUTION NM
PRODUCT Recovered Plasma,
CODE
Unit: 6649661
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
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 Source Plasma,
CODE
Unit:
KZ038995
RECALLING FIRM/MANUFACTURER Plasma Biological
Services, Inc., Memphis, TN,
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 Austria
PRODUCT Source Plasma,
CODE
Unit:
KP110533
RECALLING FIRM/MANUFACTURER Plasma Biological
Services, Inc., Memphis, TN,
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 Recovered Plasma,
CODE
Unit: 026KG0809
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: American Red Cross Blood Services,
Montgomery, AL.
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: 041LX50807
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: American Red Cross Blood Services, Alabama
Region, Huntsville, AL.
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: 026FK65286
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services,
Birmingham, AL,
Manufacturer: The American National Red Cross,
Mobile, AL.
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 Units: 019GV27116; 019LJ29154
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 CA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit: GW27794
RECALLING
FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood product, which may have reached an
unacceptable temperature during shipment, was distributed.
VOLUME OF
PRODUCT IN COMMERCE
1
unit
DISTRIBUTION WI