AUGUST 2003
WEEK ENDING AUGUST 2
PRODUCT
Red Blood
Cells.
CODE Unit number 6822793.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center,
Tyler, TX.
REASON Blood product, collected in an expired collection bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells Washed.
CODE Units 6966406 and 6973760.
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ.
REASON Blood products, which were prepared using 1.6% saline solution
instead of the .9% saline solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 01GY69999.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New
York-Penn Region, West Henrietta, NY.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Human Tissues for Transplantation.
a) Temporal Bone Core;
b) Temporal Bone Blocks.
CODE
a) ID#EB1069;
b) ID#EB1069, EB1092, EB1139.
RECALLING FIRM/MANUFACTURER Recalling Firm: Providence Health Care, St.
Paul's Hospital Site, Vancouver, BC.
Manufacturer: BC Ear Bank, % St Paul's Hospital, Vancouver, BC.
REASON Tissues for transplantation, for which donor suitability and
tissue processing documentation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 16 units.
DISTRIBUTION PA.
PRODUCT Red Blood Cells.
CODE Unit 5356669.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood product, collected from a donor who had close contact with
a person who had hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Human tissue for transplantation, Corneas.
CODE ID number 03-0351OD, 03-0351OS.
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA.
REASON Corneas, collected from a donor who had intimate contact with an
individual diagnosed with Hepatitis C, were distributed for tansplant.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION IN.
PRODUCT Human Tissues for transplantation. Femoral Popliteal Artery SG.
CODE Serial # 8116577.
RECALLING FIRM/MANUFACTURER CryoLife, Inc, Kennesaw, GA.
REASON Human tissues for transplantation, which were associated with a
complaint of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT Genetic Systems HIV-1/HIV-2 Peptide EIA test kit.
CODE Lot 105VP1.
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc., Redmond, WA.
REASON Test kits that could produce low positive and elevated negative
controls were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION Nationwide.
PRODUCT
a) Fresh Frozen Plasma.
b) Cryoprecipitate.
c) Recovered Plasma.
CODE
a) Unit LE14726; b), and c) Unit FG67643.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood products, collected from a donor who was at increased risk
for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION ME, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets.
c) Fresh Froxen Plasma.
CODE a), b), and c) Unit LE06855.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood products, collected from a donor who was at increased risk
for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION RI.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit 7825381.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor whose medical history
screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 5290340.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor with a history
of Crohn's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Recovered Plasma.
CODE Unit number 21KC43309.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific
Northwest Region, Portland, OR.
REASON Blood product collected from an unsuitable donor due to a history
of travel to an area considered at increased risk of exposure to new variant
Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 21KK63946.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific
Northwest Region, Portland, OR.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.
PRODUCT Human Tissue for transplantation, Corneas.
CODE Tissue numbers 2003-05-4011 and 2003-05-4012.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks,
Columbia, MO.
Manufacturer: Heartland Lions Eye Banks, Hayes, KS. Firm initiated
recall is complete.
REASON Human tissue for transplantation, that tested negative for
hepatitis prior to distribution, but was subsequently found to test repeatedly
reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different
facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION KS, and Germany.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 30GH81556.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood product, collected from an ineligible donor due to use of
an antiviral medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE a), b), and c) Unit number 30GL32538.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood product collected from an unsuitable donor due to a history
of travel to an area considered at increased risk of exposure to new variant
Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA, PA, and Switzerland.
PRODUCT
a) Red Blood Cells. b) Platelets, Irradiated.
CODE
a) and b)
Unit number 9745369.
RECALLING FIRM/MANUFACTURER Our Lady of the Lake Hospital, Inc., Baton
Rouge, LA.
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 unit.
DISTRIBUTION LA.
PRODUCT Red Blood Cells.
CODE Unit number 9957364.
RECALLING FIRM/MANUFACTURER Our Lady of the Lake Hospital, Inc., Baton
Rouge, LA.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Platelets.
CODE
Unit number
9954288.
RECALLING FIRM/MANUFACTURER Our Lady of the Lake Hospital, Inc., Baton
Rouge, LA.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT a) Red Blood Cells,
Leukocytes. b) Red Blood Cells, Leukocytes, Irradiated.
CODE
a) Unit numbers 01LW29287, 01LW29305;
b) Unit number 01LW29292.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New
York-Penn Region, West Henrietta, NY.
REASON Blood products, collected in expired blood collection bags, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 1 unit.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukoreduced.
CODE L40356, G18744, G18751, G18844.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank,
Springfield, IL.
REASON Blood products, leukoreduced by filtration greater than five days
past time of collection, but within the shelf life of the units, were
distributed.
VOLUME OF PRODUCT IN COMMERCE4 units.
DISTRIBUTION IL.
PRODUCT
a) Red Blood Cells. b) Recovered
Plasma.
CODE a) and b) Unit 7827534.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, collected from an ineligible donor with a history
of Crohn's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and Switzerland.
PRODUCT
a) Red Blood Cells. b) Cryoprecipitate. c) Recovered Plasma.
CODE a), b), and c) Unit 7832759.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, collected from a donor whose arm inspection was
not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, MO, and Switzerland.
PRODUCT Tissues for Transplantation:
a) Achilles;
b) Cancellous;
c) 1/2 Patella;
d) Femur;
e) Cortical Shaft;
f) Cortical Segment;
g) Bone Plug;
h) Cortical Disc;
i) Iliac Crest Wedge.
CODE
a) PBA-62500001-02, PBA-62500002-02;
b) PBA-62500058-02, PBA-62500060-02, PBA-62500063-02, PBA-62500007-02,
PBA-62500053-02, PBA-62500061-02, PBA-62500054-02, PBA-62500056-02,
PBA-62500057-02, PBA-62500059-02;
c) PBA-62500003-02, PBA-62500005-02, PBA-62500006-02;
d) PBA-62500008-02;
e) PBA-62500010-02;
f) PBA-62500011-02;
g) PBA-62500018-02, PBA-62500023-02;
h) PBA-62500040-02, PBA-62500042-02, PBA-62500041-02, PBA-62500043-02,
PBA-62500044-02, PBA-62500045-02;
i) PBA-62500047-02, PBA-62500050-02, PBA-62500051-02.
RECALLING FIRM/MANUFACTURER LifeLink Foundation Tissue Bank, Tampa, FL.
REASON Tissues for
transplantation that were collected from donors who were found to test
repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to
distribution.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 10 units;
c) 3 units;
d) 1 unit;
e) 1 unit;
f) 1 unit;
g) 2 units;
h) 6 units;
i) 3 units.
DISTRIBUTION FL, GA, and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit number
FM68985.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood product, that was labeled as leukoreduced but failed
quality control testing due to an elevated white blood cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT Red Blood Cells.
CODE Unit number T43539.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw
Valley Blood Program, Saginaw, MI.
REASON An expired blood product was not properly quarantined and was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Recovered Plasma.
CODE Unit number 9035050.
RECALLING FIRM/MANUFACTURER East Jefferson General Hospital Blood Bank,
Metairie, LA.
REASON Blood product collected from an unsuitable donor due to a history
of residing in an area considered at risk of exposure to new variant
Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Fresh Frozen Plasma.
CODE
Unit
210005.
RECALLING FIRM/MANUFACTURER Aultman Hospital Association Blood Center,
Canton, OH.
REASON Blood product, collected from a donor who was at increased risk
for new variant Creutzfeldt Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Source Plasma.
CODE
0090617980,
0090617953, 0090617855, 0090617819, 0090617708, 0090617650, 0090617549, 0090617504,
0090617340, 0090617282, 0090617149, 0090617060, 0090616974, 0090616896,
0090616817, 0090616727, 0090616648, 0090616547, 0090616475, 0090616361,
0090616280, 0090616160, 0090616086, 0090615984, 0090615911, 0090615813,
0090615729, 0090615606, 0090615525, 0090615395, 0090615314, 0090615169,
0090615086, 0090614848, 0090614719, 0090614628, 0090614511, 0090614413,
0090614276, 0090614123, 0090612941, 0090612774, 0090612705, 0090612012,
0090611964 37238674, 37236595, 37233150, 37231446, 37230098, 37229016,
37227135, 37210229, 37209469, 37205553, 37204242, 37203030, 37202101, 37200633,
37199500, 37198244, 37196486, 37195182, 37194260, 37192785, 37191672, 37190514,
37188528, 37187293, 37185756, 37183714, 37181079, 37180027, 37175634, 37174361,
37173166
RECALLING FIRM/MANUFACTURER NABI Biomedical Center, Scranton, PA.
REASON Blood products, collected from a donor who had a tattoo within
twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 76 units.
DISTRIBUTION PA, CA, Israel, and
Scotland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Irradiated.
c)
Platelets.
d) Platelets, Leukocytes Reduced.
e) Platelets, Pheresis, Leukocytes Reduced.
f) Platelets, Pheresis, Irradiated.
g) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
h) Fresh Frozen Plasma.
i) Cryoprecipitated AHF.
j) Plasma.
CODE
a) FH29405, FH29406, FH29407, FH29408, FH29409, FH29410, FH29411, FH29412,
FH29413, FH29414, FH29415, FH29416, FH29417, FH29418, FH29420, FH29421,
FH29422, FH29423, FH29424, FH29425, FH29426, FT99923, FT99924, FT99925,
FT99926, FT99928, FT99929, FT99930, FT99931, FT99932, FT99933, FT99934,
FT99935, FT99936, FT99937, FT99939, FT99940, FT99942, FT99943, FT99944,
FT99945, FT99946, FT99947, FT99949, FT99950, FT99951, FT99952, FT99953,
FT99955, FT99956, FT99957, FT99958, FT99959, FT99962, FT99963, FT99964,
FT99966, FT99967, FT99968, FT99969, FT99970, FT99971, KS09091, KS09092,
KS09093, KS09094, KS09095, KS09096, KS09097, KS09098, KS09099, KS09101,
KS09102, KS09103, KS09104, KS09105, KS09106, KS09107, KS09108, KS09109,
KS09110, KS09111, KS09112, KS09113, KS09114, KS09115, KS09116, KS09118,
KS09119, KS09120, KS09121, KS09122, KS09123, KS09124, KS09125, KS09126,
KS09127, KS09128, KS09129, KS09130, KS09131, KS09132, KS09133, KS09135,
KS09137, KS09138, KS09139, KS09140, KS09141, KS09142, KS09143, KS09144,
KS09145, KS09146, KS09147, KS09148, KS09149, KS09151, KS09154, KS09155,
KS09156, KS09157, KS09158, KS09160, KS09161, KS09162, KS09163, KS09164,
KS09166, KS09167, KS09168, KS09169, KS09170, KS09171, KS09172, KS09174,
KS09175, KS09176, KS09177, KS09178, KS09179, KS09180, KS09181, KS09182,
KS09183, KS09184, KS09185, KS09186, KS09187, KS09188, KS09189, LC20654,
LC20655, LC20656, LC20658, LC20659, LC20660, LC20661, LC20662, LC20663,
LC20664, LC20665, LC20666, LC20667, LC20668, LC20669, LC20670, LC20672,
LC20673, LC20674, LC20675, LC20676, LC20677, LC20678, LC20679, LC20680,
FT99925, FT99930, FT99932, FT99933, FT99934, FT99935, T99937, FT99942, FT99943,
FT99944, FT99945, FT99949, FT99951;
b) KS09153;
c) FT99925, FT99930, FT99932, FT99933, FT99934, FT99935, FT99937, FT99942,
FT99943, FT99944, FT99945, FT99949, FT99951;
d) FT99921 (2 splits), FT99922, FT99926, FT99938;
e) FT99963, LC20671 (3 splits);
f) FT99922, FT99926, FT99938, FT99954;
g) FT99920;
h) FH29406, FH29412, FH29414, FH29416, FH29424, FT99923, FT99932, FT99933,
FT99935, FT99942, FT99943, FT99951, FT99952, FT99953 (split units), FT99956,
FT99959, FT99964, FT99966, FT99971, KS09091 (split units), KS09113, KS09116,
KS09123(split units), KS09128, KS09129, KS09137, KS09140(split units), KS09143,
KS09154, KS09157, KS09160, KS09163, KS09164, KS09166, KS09167, KS09168,
KS09171, KS09172, KS09174, KS09177, KS09179, KS09180, KS09181, KS09189
i) FT99931, KS09093, KS09096, KS09097, KS09098, KS09099, KS09101, KS09102,
KS09105, KS09106, KS09107, KS09110, KS09111, KS09115, KS09118, KS09119,
KS09120, KS09131, KS09122, KS09124, KS09125, KS09127, KS09136, KS09139,
KS09141, KS09145, KS09146, KS09147, KS09148, KS09149, KS09151, KS09153,
LC20658, LC20659, LC20661, LC20662, LC20663, LC20664, LC20665, LC20666,
LC20667, LC20669, LC20670, LC20673, LC20674, LC20676, LC20678, LC20679;
j) KS09093, KS09105, KS09118, KS09139.
RECALLING FIRM/MANUFACTURER Inova Health System, Blood Donor Services,
Annandale, VA.
REASON Blood products, incorrectly tested for syphilis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 176 units;
b) 1 unit;
c) 13 units;
d) 5 units;
e) 4 units;
f) 4 units;
g) 1 unit;
h) 49 units;
i) 48 units;
j) 4 units.
DISTRIBUTION VA, MD, and D.C.
PRODUCT Red Blood Cells.
CODE Unit 6556662.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, IN.
REASON Blood product, mislabeled as having been tested by NAT for HIV
and HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) Unit J69016;
b) Units J69016, J69412.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw
Valley Blood, Saginaw, MI.
REASON Blood products, collected from an unsuitable donor based on
travel to area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE
a), and b) Units 38FK24368, 38FK23499.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood products, collected from a donor taking the drug
Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION IN, and NC.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1434-3.
CODE
a) Unit numbers 11005909, 11006938, 11007822, 11008816, 11020399, 11021067,
11021753, 11022707, 11023533;
b) Unit number 11019730.
RECALLING FIRM/MANUFACTURER W.E. and Lela I. Stewart Blood Center,
Tyler, TX.
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
a) 9 units;
b) 1 unit.
DISTRIBUTION TX.
PRODUCT Platelets.
CODE Unit number 91-86411.
RECALLING FIRM/MANUFACTURER Medic, Inc, Knoxville, TN.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 9065066 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
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 2 units.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE
a) Unit numbers 90-55646, 90-61262, 90-61898, 90-67011, 90-55965, 90-67231, and
90-70748;
b) Unit number 9065066 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, collected from an unsuitable donor based on
travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 1 unit;
b) 7 units.
DISTRIBUTION TN, and KY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) Unit numbers 90-65239 and 94-81988;
b) Unit number 90-65239.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
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 3 units.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) Unit 34027138;
b) Unit 34028850.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood products, collected from a donor whose eligibility to
donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit 34027009.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood products, collected from a donor whose eligibility to
donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit 10021325.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center, Inc.,
Tyler, TX.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Platelets, Pheresis.
CODE Unit 10022651.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, collected in a manner that may have affected the
sensitivity of viral marker test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE
Unit
12011400.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, which was labeled as leukoreduced, but did not
meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Units GP54665, GP64415, GP64203.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN.
REASON Blood products, collected from an unsuitable donor due to
behavior associated with an increased risk of infection with the human
immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA, Vienna, and Austria.
PRODUCT
a) Red Blood Cells.
b)
Platelets.
CODE
a) and b) Unit number K90576.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, IL.
REASON Blood products, that tested negative for viral markers, but were
collected from an unsuitable donor due to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit number R20297.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, IL.
REASON Blood products, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but were collected from a donor that
previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL, and CA.
PRODUCT
a) Red Blood Cells.
b)
Recovered Plasma.
CODE
a) and b)
Unit 30025565.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood products, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but were collected from a donor that
previously tested repeatedly reactive for anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 6835898, 6835900, 6835903, and 6835904.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood products, collected using a phlebotomy method that may have
compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit number 33019935.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, manufactured from an overweight unit of Whole
Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Platelets, Pheresis, Leukoreduced Irradiated.
CODE
Unit
9067395 (A&B).
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, which were labeled leukoreduced but had an
elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 6704359.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood products, collected from a donor with a history of
jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Source Plasma.
CODE
Unit
92194526.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN.
REASON Blood product, collected from a donor who had body piercing
within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Allergenic Extract, Mite (D, pteronyssinus), scratch vials.
CODE Lot number 326042299.
RECALLING FIRM/MANUFACTURER Allergy Laboratories, Inc., Oklahoma City,
OK.
REASON Allergenic extract, labeled with the incorrect expiration date,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 vials of 1 lot.
DISTRIBUTION VA, TX, OK, KN, and MA.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit numbers 042FN11160 and 042Y34192;
b) Unit numbers 042FJ12443 and 042S94980.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
Ohio Region, Cleveland, OH.
REASON
Blood
products, collected from donors whose body temperature was not properly
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Recovered Plasma.
CODE
a) Unit number 01GG40727;
b) Unit number 01GG49030;
c), and d) Unit numbers 01GG40727 and 01GG49030.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red
Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm
initiated recall is complete.
REASON Blood products, that tested negative for hepatitis, but were
collected from an ineligible donor due to a history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NY, and CA.
PRODUCT Red Blood Cells.
CODE Units 6814988, 8246928, 4031556, 82337732, 2733153, 8414722,
2898803, 7807747, 8235476, 8247304.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc.
REASON Blood products, exposed to unacceptable shipping temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION IN.
PRODUCT Platelets.
CODE Unit 7917032.
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St.
Petersburg, FL.
REASON Blood product, corresponding to a unit of Red Blood Cells that was
implicated in a transfusion reaction and contaminated with Propionibacterium
acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Red Blood Cells.
CODE Unit 15002456.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, labeled with an incorrect expiration date, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Unit GP56843.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN.
REASON Blood products, collected from an unsuitable donor due to
behavior associated with an increased risk of infection with the human
immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA, Vienna, and Austria.
PRODUCT Fresh Frozen Plasma.
CODE
Unit number
91602298.
RECALLING FIRM/MANUFACTURER Vermont Blood Center, Williston, VT.
REASON Blood product, prepared more than eight hours after collection of
the corresponding unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VT.
PRODUCT Platelets.
CODE Unit number F68743.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, IL.
REASON Blood product, manufactured from a unit of Whole Blood that had
extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells.
CODE
Unit
numbers 6801456 and 6801459.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center,
Tyler, TX.
REASON Blood products possibly exposed to unacceptable storage
temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukoreduced, Irradiated.
CODE Units 231471951, 231471949.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Billings, MT.
REASON Blood products, which were stored at unacceptable temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MT.
PRODUCT Source Plasma.
CODE Unit numbers 0270736 and 0271056.
RECALLING FIRM/MANUFACTURER Bowling Green Biologicals, LLC, Bowling
Green, KY.
REASON Blood products, that tested negative for the antibody to
hepatitis C virus (anti-HCV), but were not properly quarantined after the
receipt of subsequent repeatedly reactive anti-HCV results for the donor of the
unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit number 01LT39640.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red
Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Tonawanda, NY. Firm
initiated recall is complete.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 2400464.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 90-67393.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 9074964.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE
Unit
numbers 9065015, 9065992, 9067059, 9068964, 9069520, 9070768, 9072522, 2000374,
2001588, and 2002701.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
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 10 units.
DISTRIBUTION TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 9486656.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, collected from a donor who disclosed recent blood
product administration or tissue implant during the screening process, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelet Pheresis, Leukocytes Reduced.
CODE Unit 6809308-1.
RECALLING FIRM/MANUFACTURER W.E & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, with a platelet count below recommended minimum
requirements, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit 6811510.
RECALLING FIRM/MANUFACTURER W.E & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood product, collected from a donor with hematocrit below
acceptable standards, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit 11023064.
RECALLING FIRM/MANUFACTURER W.E & Lela I. Stewart Blood Center,
Tyler, TX.
REASON Blood product, collected from a donor who disclosed a history of
jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT a) Platelet, Pheresis. b) Platelets.
CODE a) Unit 7058013 (Split unit); b) Unit 1512911.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products, collected from a donor taking the drug DayPro,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT
a)
Red Blood Cells, Leukoreduced.
b) Fresh Frozen Plasma.
c) Platelets. .
CODE
a) Units 16-364-2604, 16-364-2873, 16-364-2871, 16-364-2870, 16-364-2608;
b)Units 6-364-3028, 16-363-3135, 16-363-1696;
c)Unit 16-364-2870.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood products, collected from a donor whose health history
screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION MS, and Switzerland.
PRODUCT Source Plasma.
CODE Unit numbers GP65657, GP65318, GP65152, GP64664, GP64347, GP64201,
GP63700, GP63345, GP63191, GP62863, GP62728, GP62446, GP62305, GP61885,
GP61718, GP61377, GP61226 and GP60291.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN.
REASON Blood products, collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION Germany.
PRODUCT
Red Blood
Cells, Leukocytes Reduced.
CODE Unit numbers 14003195, 34040809.
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart Blood Center,
Inc., Tyler, TX.
REASON Blood products, which failed that parameters for red cell recovery,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 95-47223 and 95-47231.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products exposed to unacceptable shipping temperatures were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.
PRODUCT
a) Recovered Plasma. b) Red Blood Cells (For Manufacturing use only).
CODE
a)Unit
16-364-2873. b)Unit 16-364-3152.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood products, collected from a donor whose health history
screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS, and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 24KH91160.
RECALLING FIRM/MANUFACTURER The American National Red Cross, River
Valley Region, Louisville, KY.
REASON Blood product, manufactured from a unit of Whole Blood more than
8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
a) Platelet, Leukocytes Reduced Irradiated.
b) Platelets, Leukocytes Reduced Pooled.
c) Fresh Frozen Plasma.
CODE
a) Unit number 0939745;
b) Pool number 0083363;
c) Unit number 087161.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products, collected from an unsuitable donor based on the
donor's disclosure of illness with a blood clotting disorder, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 1 unit;
b) 1 pool;
c) 1 unit.
DISTRIBUTION OH.
PRODUCT Source Plasma. .
CODE Unit number 8SZ602.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood product, collected from a donor with an elevated body
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Tecan Genesis RSP and NPS Instruments:
a) Genesis RSP Instruments: Genesis RSP 100, Genesis RSP 150, Genesis RSP 200;
b) Genesis NPS Instruments: Genesis NPS 100, Genesis NPS 150.
CODE Barcode scanner type PosID 2 option and firmware version 2.45 or
lower.
RECALLING FIRM/MANUFACTURER Recalling Firm: Tecan US, Inc., Durham, NC.
Manufacturer: Tecan Schweiz Ag, Hombrechtikon, Switzerland..
REASON Pipetting instruments, in which the barcode readers fail to
correctly read sample bar code labels, were distributed.
VOLUME OF PRODUCT IN COMMERCE 327 instruments.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Red Blood Cells, Autologous.
CODE Units 10026916, 13002907.
RECALLING FIRM/MANUFACTURER W. E. & Lela I Stewart Blood Center,
Tyler, TX.
REASON Autologous blood products, which tested repeatedly reactive for
infectious disease tests, were distributed without the "Biohazard"
label on the bag.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Units GP64824 and GP64220.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN.
REASON Blood products, collected from a donor who had body piercing
within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.
PRODUCT Cornea Tissue.
CODE C-1024234-OS.
RECALLING FIRM/MANUFACTURER Michigan Eye Bank, Ann Arbor, MI.
REASON Human corneas, collected from a donor who subsequently tested
positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION OH.
PRODUCT Corneas Tissues.
CODE 2003-0569 and 2003-0570.
RECALLING FIRM/MANUFACTURER Transplant Services Center, University of
Texas, Southwestern Medical Center, Dallas, TX.
REASON Human corneas, collected from a donor who subsequently tested
positive for HIV (PCR) by another tissue procurement organization, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION TX.
PRODUCT Recovered Plasma.
CODE Unit number FG65837.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood product collected from an unsuitable donor due to a history
of residing in an area considered at increased risk of exposure to new variant
Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODE a) Unit number 2310572; b) Unit number 2310579.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON
Blood
products were collected in a manner that may compromise the sterility of the
products.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Platelets.
CODE Unit numbers 2398798, 2398790, 2398807, 2397002, 2397001, 2392931,
2395083, 2395085, 2397005, 2396901, 2396900, 2397006, 2396899, 2397008,
2398797, and 2398796.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products, manufactured from units of Whole Blood exposed to
incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION TX, and WI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 20J63252.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red
Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: The American National Red Cross, Salt Lake City, UT.
REASON Blood product, collected from an unsuitable donor based on travel
to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE a) Unit number 7060698; b) Unit number 7060698(distributed as two
split products).
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products, collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Platelets Leukocytes Removed.
CODE Unit number 04K60209.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Cleveland, OH.
REASON Blood product, which was prepared in a manner that may compromise
the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells. b)
Platelets.
CODE a) and b) Unit number 1190649.
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH.
REASON Blood products, which were collected from a donor who had
received the Hepatitis A Immune Globulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 7057350.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Irradiated.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 1816504.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 1842054.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a), b) Unit number 1890553.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and FL.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE
Unit number
0920524.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH.
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 OH.
PRODUCT Red Blood Cells Leukocytes Reduced. .
CODE Units 9536933 and 9536931.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, which were collected from a donor who had lived in
a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 2008279.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
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 TN.
PRODUCT Platelets.
CODE Unit 2011555.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, which were collected from a donor who was taking
the medication Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Red Blood Cells.
CODE Units 9032853, 9032852, and 9036306.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, which were collected from a donor who had
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 24KL61869, 24KL61871, 24KL61873, 24KL61875.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, River
Valley Region, Louisville, Ky.
REASON Red Cells, prepared more than eight hours after collection of the
corresponding Whole Blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION IN and KY.
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit 7058820.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood product, in which the corresponding blood component was
contaminated with Staphlyococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT ALYX Component Collection System.
CODE Product code 4R5707, all serial numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare
Corporation, Aka BioLife Plasma Services L.P., Round Lake, IL.
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON The main power switch on an apheresis instrument could become
dislodged and could result in an electric shock to the user.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ, NY, TX, MN, OK, FL, and LA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells for Further Manufacturer.
c) Recovered Plasma.
CODE
a) Unit number 04G25114;
b) Unit number 04S43376;
c) Unit numbers 04GF25114 and 04S43376.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Blood products, that tested negative for hepatitis, but were
collected from an ineligible donor due to a subsequent disclosure of previous
positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA, NH, MA, and Switzerland.
PRODUCT Source Plasma.
CODE Unit numbers 43Q004, 43Q014, 43Q026, 43Q038, 43Q046, 43Q059,
43Q070, 43Q083, 43Q089, 43Q100, 43Q106, 43Q114, 43Q120, 43Q131, 43Q135, 43Q148,
43Q150, 43Q161, 43Q170, 43Q181, 43Q184, 43Q196, 43Q200, 43Q211, 43Q217, 43Q228,
43Q232, 43Q239, 43Q247, 43Q256, 43Q264, 43Q268, 43Q273, 43Q279, 43Q284, 43Q874,
43Q880, 43Q886, 43Q899, 43Q907, 43Q920, 43Q925, 43Q937, 43Q946, 43Q958, 43Q967,
43Q977, 43Q992, 43Q289, 43Q294, 43Q299, 43Q305, 43Q317, 43Q320, 43Q329, 43Q340,
43Q346, 43Q357, 43Q365, 43Q372, 43Q379, 43Q386, 43Q390, 43Q394, 43Q404, 43Q417,
43Q430, 43Q436, 43Q446, 43Q457, 43Q464, 43Q467, 43Q479, 43Q483, 43Q494, 8TA653,
8TJ001, 8TJ008, 8TJ012, 8TJ020, 8TJ024, 8TJ039, 8TJ042, 8TJ050, 8TJ057, 8TJ071,
8TJ080, 8TJ084, 8TJ090, 8TJ096, 8TJ103, and 8TJ113.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood products, that tested negative for viral markers, but were
collected from a donor that was subsequently determined to have multiple risk
factors for increased incidence of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 92 units.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit
numbers 24KG49198, 24KL55687, 24KE43287, 24KW37086, 24KJ63212, 24KJ63213,
24KJ63215, 24KJ63216, 24KJ63217, 24KJ63218, 24KJ63219, 24KJ63220, 24KJ63285,
24KJ63286, 24KJ63291, 24KJ63292, 24KJ63294, 24KJ63295, 24KJ63296, 24KJ63297,
24KJ63298, 24KJ63299, 24KJ63301, 24KJ63302, 24KJ63303, 24KJ63304, 24KJ63305,
24KJ63306, 24KJ63307, 24KJ63308, 24FC10903, 24KS47844, 24KH82494, 24KY53639,
24KY53641, 24KH84228, 24KH84229, 24KH84230, 24KH84232, 24KH84294, 24KC29854,
24KY55230, 24KL58889, 24KQ51380, 24KQ51381, 24KQ51382, 24KQ51384, 24KC30359,
24KH86379, 24KH86380, 24KH86381, 24KE45500, 24KL59603, 24KH86707, 24KG52580,
24KS51211, 24GQ64729, 24KW37260, 24KS47806, 24GQ63978, 24KM79669, 24KG54165,
24KL61584, 24KC31398, 24KC31377, 24KH89351, 24KH90316, 24KH90315, 24KH90317,
and 24KS51899.
RECALLING FIRM/MANUFACTURER The American National Red Cross, River
Valley Region, Louisville, KY.
REASON Blood products, manufactured from units of Whole Blood more than
8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 70 units.
DISTRIBUTION KY, IN, IL, SC, and AL.
PRODUCT Platelets, Leukoreduced.
CODE Unit 042FT32162.
RECALLING FIRM/MANUFACTURER The American Red Cross, Northern Ohio
Region, Cleveland, OH.
REASON Blood product, collected in a manner that may have compromised
sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Source Plasma.
CODE Units 91075154, 91072924.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Columbus, OH.
REASON Blood Products, that tested negative for antibody to hepatitis C
virus (anti-HCV), but were collected from a donor who previously tested
repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Units BMFGSJ, BMFHFY, BMFHNV.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., West Lafayette,
IN.
REASON Blood products, collected from a donor previously deferred for
evidence of possible IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets, Leukoreduced.
c) Fresh Frozen Plasma.
d) Recovered Plasma. .
CODE
a) Units 042R62178, 042Q73850, 042H32889, 042Q75667, 042S93524, 042S94359;
b) Units 042R62178, 042Q73850;
c) Unit 042R62178;
d) Units 042Q73850, 042H32889, 042Q75667, 042S93524, 042S94359.
RECALLING FIRM/MANUFACTURER The American Red Cross, Northern Ohio
Region, Cleveland, OH.
REASON Blood products, collected from a donor who resided in an area
considered at increased risk of exposure to new variant Creutzfeldt-Jakob
Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION OH.
PRODUCT
Platelets
Leukocytes Reduced. .
CODE Unit 27LC28068.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Johnstown, PA.
REASON Blood product, which was identified as having a discrepant
collection time and was not appropriately quarantined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Saphenous Vein.
CODE Unit 7041472.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Human tissue intended for transplantation, which was associated
with tissue that may have been contaminated with gram-negative Staphylococcus
microorganism, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Canada.
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.
CODE Units 2016301 and 2016291.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood products, which were labeled with an incorrect expiration
date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 2502870.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, which was prepared in a manner that may compromise
the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelets Pheresis Leukocytes Removed.
CODE Unit 2006852.
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN.
REASON Blood product, which was received at a temperature above
acceptable limits, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 24KL61877, 24KS52150.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, River
Valley Region, Louisville, KY.
REASON Red Cells, prepared more than eight hours after collection of the
corresponding Whole Blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and KY.