JULY 2002
WEEK
ENDING JULY 6
PRODUCT a) Human Tissue for Transplantation of the following
types:
b)
Femoral-Politeal Artery SG
c)
Right Medial Femoral Condyle
d)
Left Lateral Femoral Condyle
e)
Semitendinosis/Gracilis Tendon
f)
Tibialis Tendon
g) Pulmonary
Monocusp Hemi-Artery
h)
Right Lateral Femoral Condyle.
CODE
a)
Numbers 7718049 and 7718051
b)
Number 7707487
c)
Number 7707494
d)
Number 7707372
e)
Number 7707539
f)
Number 7706651
g)
Number 7707477
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Human tissue for transplantation, associated with
tissue that was implanted in a recipient that subsequently developed a
bacterial
infection
with Clostridium bifermentans, was distributed.
VOLUME OF PRODUCT IN COMMERCE 7 tissues.
DISTRIBUTION TX, FL, TN, WI, OH and GA.
PRODUCT Corneas, Human Tissue for Transplantation
CODE Numbers 02-0597 and 02-0598.
RECALLING FIRM/MANUFACTURER Georgia Eye Bank, Inc.,
Atlanta, GA
REASON Human tissue for transplantation was procured from a
donor that tested positive for human immunodeficiency virus (HIV) by the
polymerase chain reaction (PCR) assay.
VOLUME OF PRODUCT IN COMMERCE 2 corneas.
DISTRIBUTION GA.
PRODUCT a) Patella Tendon, Bisected, Fresh Frozen, Irradiated
In addition, the following products were procured from the same donor and
not
included in the recall notification:
b)
Achilles Tendon
c)
Fascia
d)
Femoral Head
e)
Lumbar
f)
Skin
g)
Crushed Cancellous Chips.
CODE a) Numbers 99126-008 and 99126-009; In addition, the
following products were procured from the same donor and not included in the
recall notification: b) Numbers 99126-004 and 99126-005; c) Number 99126-003;
d) Numbers 99126-010 and 99126-011; e) Number 99126-034;
f)
Numbers 99126-001 and 99126-002; g) Numbers 99126-012, 99126-013, 99126-014,
99126-015, 99126-016, 99126-017, 99126-018, 99126-019, 99126-020, 99126-021,
99126-022, 99126-023, 99126-024, 99126-025, 99126-027, 99126-028, 99126-030,
99126-031, 99126-032, and 99126-033.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood
and Tissue Center, Austin, TX
REASON Human tissue for transplantation, associated with
tissue that was implanted in recipients that subsequently developed bacterial
infections, was distributed.
VOLUME OF PRODUCT IN COMMERCE 30 tissues.
DISTRIBUTION SC and TX.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit 53FH89968.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD
REASON Blood product, collected from a donor who was taking
the drug Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma; e) Source Leukocytes
CODE a) Units 22LR41265, 22LM28239, 22FX24558; b) Units
22LM28239, 22FX24558; c) Units 22LM28239, 22FX24558, 22FX20504; d) Unit
22LR41265; e) Unit 22 FX20504
RECALLING FIRM/MANUFACTURER American Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood products, collected from a donor with a
history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION PA, NY and NJ.
PRODUCT Source Plasma
CODE Units G-65858-032, G-65739-032, G66974-032.
RECALLING FIRM/MANUFACTURER Alpha Therapeutics Corp., City
of Industry, CA
REASON Source Plasma, collected from donors who had tattoos
applied within the past 12 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Spain.
PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Units 35Z11343, 35Z11347, 35Z11351, 35Z11353 and
35Z11348.
RECALLING FIRM/MANUFACTURER American Red Cross,
Appalachian Region, Roanoke, VA
REASON Blood products, collected on an instrument that was
not validated for leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION VA.
PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated
CODE Unit W49129.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood product, which was labeled leukoreduced but
had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Source Plasma
CODE Unit 57185057.
RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS
REASON Blood product, collected from a donor whose health history
screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) Units R11410, W20111; b) Unit W20111.
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA and MD.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit 53J64496.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.
PRODUCT Red Blood Cells
CODE Unit number 36261-2229.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Ventura, CA.
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 Source Plasma
CODE Units 76F336, 76G590, 76G081, 76G206, 76G453,
76F636, 76H090, 76H269, 76H491, 76H696, 76H897, 76I140, 76I305, 76I560, 76I739,
9Q4619, 9Q4904, 9Q5033, 9Q5269, 9A5448, 9Q5709, 9Q5877, 9SY532, CKCTGT, CKCTMF,
CKCVBC, CKCVGD, CKCVRW, CKCWBY, CKCXLZ, CKCXYX, CKCYYK
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 32 units.
DISTRIBUTION IL. And Germany
PRODUCT Source Plasma
CODE Units 73G189, 73G287, 73G504, 73G589, 73G810,
73G922.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units
9ZU248, 9ZU316, CKCMSM, CKCWZL, CKCXMD
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of crystal meth use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 9XT460, 9ZS909, CKBPWH, SKBSFC, SKBSMB,
CKBSWC.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine and crystal meth use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 73J676, 73J787, 73K237, 73K799, 73M059,
CFFLVM, CFFMHD, CFFNCY, CFFNSF, CFFPKL, CFFQDP, CFFRMZ, CFFSNY, CFFSZZ, CFFWLM,
CFFXXJ, CFFYXJ, CFFZGR, CFGBDJ, CFGBVH, CFGCHN, CFGCWP, CFGDMN, CFGDWQ, CFGRSV,
CFGSPH, CFGSYN
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 73N653, 73N731, 73P056, 73P207, 73P432,
73P569, 73P887, 73Q004, 73Q400, 73Q526, 73Q837, 73R064, 73R401, 73R645, 73R956,
73S082, 73S612, 73S780, 73U044, 73U804, 73U921, 73V375, 73V695, 73V792, 74A192,
74A283, 74A670, 74B147, 74B248, 74B601, 74B731, 74C049, 74C220, 74C521, 74D818,
76A255, 76A461, 76A751, 76A881, 76B497, 76B638, 76B819, 76B987, 76C293, 76D030.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of crystal meth use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units.
DISTRIBUTION IL and Germany.
PRODUCT Source Plasma
CODE Units 9ZS767, 9ZS845, 9ZT117, 9ZT1027, 9ZT302,
9XT318, CKBBSG.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 73A181, 73A296, 73A516.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of crystal meth use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units 74B749, 74C018, 74C331.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units CKCRZZ, CKCSFX, CKCSVD, CKCTGP, CKCTMK,
CKCVDW, CKCMNK, CKCNVB, CKCNWW, CKCPBZ, CKCPDS, CKCPKD, CKCPNB, CKCPPR, CKCPSR,
CKCPVG, CKDHSK, CKDHWG.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of using hard drugs, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION IL and Germany.
PRODUCT Source Plasma
CODE Units 73Q441, 73Q678, 73R131, 73R201, 73R526,
73S055, 73S268, 73T232, 73T379, 73T673, 73U579, 73U705, 73V035, 73V204, 73V814,
73V988, 74A317, 74A480, 74B149, 74B290, 74B776, 74B945.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units CFCRWG, CFCSDY, CFCSVQ, CFCTDW, CFCTTN,
CFCVCY, CFCVSS, CFCWRP, CFDCVR, CFDCWY, CFDCZP, CFDDFD, CFDBSR
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Tucson, AZ
REASON Blood products, collected from a donor with a
history of cocaine use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION IL and Germany.
PRODUCT Corneas
CODE Tissue numbers 2002-05-2023 and 2002-05-2024.
RECALLING FIRM/MANUFACTURER Heartland Lions Eye Banks,
Columbia, MO
REASON Human tissue for transplantation, that tested
negative for hepatitis prior to distribution, but was subsequently found to
test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc)
by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION NY.
PRODUCT a) Cryoprecipitated AHF; b) Plasma
CODE a) and b) Unit number S11205.
RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan
Community Blood Centers, Grand Rapids, MI
Manufacturer:
Michigan Community Blood Centers, Saginaw, MI.
REASON Blood products, collected from an ineligible donor
due to use of the medication Lipitor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI and NV.
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Unit KZ62978-1.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which had a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells
CODE Unit number
LX05804.
RECALLING FIRM/MANUFACTURER Inova Health Care Services,
Annandale, VA
REASON Blood product, that tested negative for viral
markers, but was collected from a donor who disclosed a risk factor for
increased incidence of infection with human immunodeficiency virus (HIV), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 32KE53743.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Badger-Hawkeye Region, Madison, WI
REASON Blood product, manufactured from a unit of Whole
Blood that was stored at room temperature for more than 8 hours after
collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells
CODE Unit number FS99623.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Annandale,
VA
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 VA.
PRODUCT Red Blood Cells
CODE Unit number LN52627.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeast Wisconsin, Inc., Milwaukee, WI
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE WI.
DISTRIBUTION 1 unit.
PRODUCT Red Blood Cells
CODE Unit number 29FF47588.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Mid-Atlantic Region, Norfolk, VA
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 VA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 29KL26170 and 29KN26855.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA and NC.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) Unit numbers 53FE70174, 53FE68916, and 53FE66885
b) Unit number 53FE70174
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Chesapeake and Potomac Region, Baltimore, MD
REASON Blood products, collected from an unsuitable donor
based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MD and Washington DC.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
Pheresis; c) Platelets Pheresis, Leukocytes Reduced; d) Platelets Pheresis,
Irradiated
CODE a) Unit number 07FK60316; b) Unit number 07FR11875
(distributed as two split units); c) and d) Unit number 07FP11052.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Arizona Region, Tucson, AZ
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 5 units.
DISTRIBUTION AZ.
PRODUCT Collagenase Santyl? Ointment (1 lot), 250 units per
gram, 15 gram tubes
CODE Lot number 01SO151053.
RECALLING FIRM/MANUFACTURER Advance Biofactures
Corporation,Lynbrook, NY
REASON Product was manufactured during a period when
leaking container tubes were encountered due to a problem on the manufacturing
line.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION FL.
PRODUCT Source Plasma
CODE Unit 57185859.
RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS
REASON Blood product, collected from a donor whose health
history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukoreduced
CODE Units FQ12572.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood product, collected from a donor with a history
of treatment for Lyme disease was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Platelets
CODE Unit 22FK86721.
RECALLING FIRM/MANUFACTURER American Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood product, which may have contained the additive
solution Adsol, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma
CODE a) and b) Unit number 29KF14979.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Mid-Atlantic Region,Norfolk, VA
REASON Blood products, collected from a donor that did not
answer one of the medical history questions concerning behavior known to
increase risk of infection with the human immunodeficiency virus (HIV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number LW16913.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood product, that was leukoreduced using an
expired filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Fresh Frozen Plasma
CODE Unit numbers 5118528, 5116574, 5117854, 5117850,
5117851, 5116449, and 5119939
RECALLING FIRM/MANUFACTURER Department of the Navy,
Naval Medical Center Portsmouth Blood Bank, Portsmouth, VA
REASON Blood products, that were not frozen within 8 hours
of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION NJ, VA, CA, Germany, Cuba and Washington, DC.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Recovered Plasma
CODE a) Unit number 07GX01562; b) and c) Unit numbers 07FG83774
and 07FJ50079.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Arizona Region, Tucson, AZ
REASON Blood products, collected from donors whose arm
inspection were not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AZ and CA.
PRODUCT Source Plasma
CODE Unit number VP-29652.
RECALLING FIRM/MANUFACTURER Pyramid Biological
Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma
CODE Unit number G-87181-046.
RECALLING FIRM/MANUFACTURER Pyramid Biological
Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm
inspection was not acceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelets, Irradiated
CODE Units 32KN01500, 32KN01524
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Madison, WI
REASON Blood products, which were irradiated twice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI.
WEEK ENDING JULY 13
PRODUCT Platelets, Pheresis, Leukoreduced
CODE Units FJ68112-1, FR32706-1, FR32715-1, FR32715-2, FR32769-2,
FW11391-1, FW11653-1, FW11653-2, KM30022-1, KM30022-2,
KZ56547-1,
KZ56547-2, KZ56547-3, KZ56611-1, KZ56611-2, KZ56621-1, LH56337-1, LH56337-2,
LH56337-3, LH56347-1, LH56351-1, LH56354-1, LH56358-1, LH56390-1, LX99610-2,
LX99617-1, LX99617-2
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which had a low platelet count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION WI.
PRODUCT Red Blood Cells Leukocytes Removed
CODE Units 40GV24714 and 40GT35540.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Peoria, IL
REASON Blood products, which were collected from a donor
who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL
and VA.
PRODUCT Red Blood Cells Leukocytes Removed
CODE Unit 40GV32117 and 40GL86809.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Peoria, IL
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 IL and MO.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number LP01938.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood product, collected from a donor that did not
have a hemoglobin determination performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit number 6799821.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
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 LA.
PRODUCT Red Blood Cells
CODE Unit numbers 1918812 and 1914241.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, 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 units.
DISTRIBUTION LA.
PRODUCT Red Blood Cells, Leukoreduced
CODE Units 32KN00524, 32KJ88267, 32KJ88269, 32KJ88270,
32KJ88271, 32KJ88272, 32KJ88273, 32KJ88274, 32KJ88275, 32KJ88276,
32KJ88278,
32KJ88280, 32KJ88281, 32KJ88282, 32KJ88283, 32KJ88286, 32KJ88288, 32KJ88291,
32KJ88293, 32KJ88294.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Badger-Hawkeye Region, Madison, WI
REASON Blood products, which were not refrigerated within 8
hours of Whole Blood collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION CA, IL, MI, PA and WI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
Pooled; c) Recovered Plasma.
CODE a) Unit numbers FW23786 and LP37858; b) Pool numbers
P13855 and P26369; c) Unit number LP37858.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeast Wisconsin, Inc., Milwaukee, WI
REASON Blood products, collected from an ineligible donor
due to medication with antibiotics, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION WI and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number LP41937.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeast Wisconsin, Inc., Milwaukee, WI
REASON Blood product, collected from an ineligible donor
due to a history of ulcerative colitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Source Plasma
CODE Unit numbers 00MMNB9347, 00MMNB9348, 00MMNB9356,
00MMNB9386, 00MMNB9602, 00MMNB9862, 00MMNB9995, 00MMNC0675, 00MMNC0832,
00MMNC0899, 00MMNC1119, 00MMNC1153, 00MMNC1621, 00MMNC2183, 00MMNC3459,
00MMNC5207, 00MMNC6337, 00MMNC7267, 00MMNC7623, 00MMNC8122, 00MMNC8172,
00MMNC8262, 00MMNC8438, 00MMNC8447, 00MMNC8454, 00MMNC8469, 00MMNC8797, 00MMNC8975,
00MMNC9086, 00MMNC9130, 00MMNC9248, 00MMNC9253, 00MMNC9258, 00MMNC9279,
00MMNC9568, 00MMNC9992, 00MMND0075, 00MMND0414, 00MMND0982, 00MMND2390,
00MMND3453, and 00MMND4737.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL
Manufacturer: Community Bio-Resources, Inc., Mankato,
MN.
REASON Blood products, collected from donors whose health
history screening was inadequately performed for medical history questions
concerning behavior known to increase risk of infection with the human
immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 42 units.
DISTRIBUTION MI and Austria.
PRODUCT Red Blood Cells
CODE Unit number 6894702.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport,
LA
REASON Blood product, labeled with an extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Collagenase, Santyl Ointment
CODE Lot 34901047.
RECALLING FIRM/MANUFACTURER Advance Biofactures
Corporation, a subsidiary of Biospecifics Technologies Corp., Lynbrook, NY
REASON Drug product, which did not meet potency
specifications (sub-potent), was distributed.
VOLUME OF PRODUCT IN COMMERCE 26,314 units.
DISTRIBUTION FL.
PRODUCT Collagenase, Santyl Ointment
CODE Lot 00S030K010.
RECALLING FIRM/MANUFACTURER Advance Biofactures
Corporation, a subsidiary of Biospecifics Technologies Corp., Lynbrook, NY
REASON Drug product, which did not meet potency
specifications (sub-potent), was distributed.
VOLUME OF PRODUCT IN COMMERCE 13,428.
DISTRIBUTION FL.
WEEK ENDING JULY 20
PRODUCT
Human Tissues
CODE
004811 (PLIF Spacer 11 mm) Tissue ID #s 005265601014, 005265601015,
005265601016, 005265601017;
004813
(PLIF Spacer 13 mm) Tissue ID #s 005265601011, 005265601012;
004815
(PLIF Spacer 15mm) Tissue ID #s 005265601006, 005265601007, 005265601008,
005265601009, 005265601010;
038050
(DBX Putty 5 cc) Tissue ID #s 005265601112;
239001
(ATSI BTB, Hemi) Tissue ID #s 005265601072;
460300
(Femur Distal Left OA Graft Cryopreserved) Tissue ID# 005265601001;
800150
(Canc. Chips 1.7-10 mm, 30cc) Tissue ID #s 005265601056, 005265601057,
005265601058, 005265601059, 005265601060, 005265601061, 005265601063;
800250
(Fascia Lata - Large) Tissue ID # 005265601074;
800405
(Iliac Crest Wedge) Tissue ID # s 005265601066, 005265601068, 005265601069;
800585
(Patella Wedge) Tissue ID # 005265601065
830010
(BTB W/Quad, Hemi) Tissue ID # 005265601071
830200
(Achilles Tendon w/ Calcaneus) Tissue ID # 005265601073;
830340
(Posterior Tibialis) Tissue ID # 005265601076, 05265601077;
830335
(Anterior Tibialis Tendon) Tissue ID #s 005265601078, 005265601079;
850100
(Femur Head) Tissue ID # 005265601070.
RECALLING
FIRM/MANUFACTURER Musculoskeletal Transplant Foundation, Edison, NJ
REASON
Tissues for transplant, that caused post-op infection due to Enterobacter
cloacae, and corresponded to tissue that was contaminated with Enterobacter
cloacae, were distributed
VOLUME
OF PRODUCT IN COMMERCE 77 units.
DISTRIBUTION
Nationwide.
PRODUCT
Red Blood Cells
CODE
Unit number 6490720.
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, 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 Reduced; b) Cryoprecipitated AHF; c) Plasma
CODE
a), b) and c) Unit number 11FM56341.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region,
St. Louis, MO
REASON
Blood products, that tested negative for the antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a
donor that previously tested repeatedly reactive for anti-HIV-1/2, were
distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
GA, IL and AK.
PRODUCT
Baxter Fenwal Open System and Closed System Apheresis Kits (for use with the
CS-3000Ò
or CS-3000Ò
Plus Blood Cell Separators)
a)
Open System Apheresis Kit;
b)
Semi-Closed System Apheresis Kit;
c)
Closed System Apheresis Kit
CODE
a) Product code 4R2210T, Lot H01G23055; b) Product code F4R2234, Lot H01G09104;
c) Product code 4R2180T, Lot H01G02117.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corporation, Fenwal
Division, Round Lake, IL
Manufacturer:
Baxter Healthcare Corporation, Mountain Home, AR.
REASON
Apheresis Kits, manufactured with a restriction in the Y-site above the
separation container, were distributed.
VOLUME
OF PRODUCT IN COMMERCE a)1,212; b)1,182; c)1,131.
DISTRIBUTION
TX, CA, LA and CO.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE
Unit numbers 03L32520, 03R20627, and 03H16581.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Southern Region,
Atlanta, GA
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
GA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE
Unit numbers 04P46773 and 04P46669.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham,
MA
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
MA.
PRODUCT
Red Blood Cells
CODE
Unit numbers 1119451, 1463023, and 2855530.
RECALLING
FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY
REASON
Blood products, collected from an unsuitable donor based on living in an area
considered endemic for malaria, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
NY and NJ.
PRODUCT
a)Red Blood Cells; b)Platelets
CODE
a) and b) Unit number 50LJ24330.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region,
Toledo, OH
REASON
Blood products, collected from an unsuitable donor based on living in an area
considered endemic for malaria, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
OH and MI.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma
CODE
a) Unit numbers 1549026, 1622559, 1720632, 1853103, and 1659032; b) Unit numbers
1549026 and 1659032; c) Unit number 1659032
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, that tested negative for antibodies to human immunodeficiency
virus (anti-HIV), but were collected from a donor that previously tested
repeatedly reactive for anti-HIV, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION
LA and MI.
PRODUCT
Source Plasma
CODE
Unit numbers 29582075, 27554142, and 27555316.
RECALLING
FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P., Sera-Tec
Biologicals L.P., Deerfield, IL
Manufacturer:
BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Richmond, KY
REASON
Blood products, collected from an ineligible donor due to previous
incarceration, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
CA and NY.
PRODUCT
Source Plasma
CODE
Unit numbers 57108100, 57113395, 57115399, 59105503, and 59108832.
RECALLING
FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P., Sera-Tec Biologicals
L.P., Deerfield, IL
Manufacturer:
BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Louisville, KY
REASON
Blood products, collected from an ineligible donor due to previous blood
product administration, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION
CA.
PRODUCT
Source Plasma
CODE
Unit numbers N-09822-046, N-09816-046, and VP-30144.
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON
Blood products, that tested negative for hepatitis, but were collected from an
ineligible donor due to a history of hepatitis, were
distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
CA and Austria.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced;
b) Platelets, Leukocytes Reduced;
c) Fresh Frozen Plasma
CODE
a), b), and c) Unit number 42FW86254.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region,
Cleveland, OH
REASON
Blood products, that tested negative for viral markers, but were collected from
a donor that subsequently admitted to multiple risk
factors
for increased incidence of infection with human immunodeficiency virus (HIV),
were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
OH.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma
CODE
a), b) and c) Unit numbers 04LE83445 and 04LE81781.
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 6 units.
DISTRIBUTION
MA, ME and CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE
Unit numbers 04P46592, 04P46595, 04P46605, and 04P46588 (distributed as two
split units).
RECALLING
FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham,
MA
REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm'