AUGUST 2001
WEEK ENDING AUGUST 4
PRODUCT
AND CODE: Crushed Cancellous Chips
Tissue ID #s 990078-003,
990078-004, 990078-005, 990078-006, 990078-007,
990078-008,
990078-009, 990078-012, 990078-014, 990078-019, 990078-021, 990078-022,
990078-023
Fascia
Lata Tissue ID #990078-024, 990078-025
Achilles
Tendon Tissue ID #990078-027
Cortical
Cancelleous, unprocessed Tissue ID #990078-028
Unprocessed
Cartilage Tissue ID #990078-002
REASON: Tissues for transplant, that were contaminated
with E.coli, or corresponded to a donor whose tissue was implicated in the
transmission of E-coli, were distributed.
MANUFACTURER/RECALLING FIRM: South Texas Blood and
Tissue Center, San Antonio, Texas
DISTRIBUTION: TX and CA
QUANTITY: 18
PRODUCT AND CODE: Source Plasma, units
G-53071-009, G-53091-009
REASON: Blood products, collected in manner that
compromised the sterility of the units, were distributed.
MANUFACTURER: Alpha Therapeutic Corporation, Tacoma, WA
RECALL BY: Alpha Therapeutic Corporation, Los Angeles,
CA
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
H68034; Platelets, unit H68034; Frozen Recovered Plasma, unit H68034
REASON: Blood products, which tested negative for antibody
to hepatitis C virus (anti-HCV), but collected from a donor that previously
tested repeatedly reactive, were distributed.
MANUFACTURER/RECALLING FIRM: Nueces County Medical
Society Community, Corpus Christi, TX
DISTRIBUTION: TX and CA
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma Units 31608961, 28487654, 27826591, 27627884,
27460436, 27458808, 27453704, 27451076, 27375105, 27372883, 23366787, 23364462,
23198203, 23195417, 23498259, 23495678, 23108882, 23106291, 23101180, 22294265,
22291639, 26087191, 23520394, 23514430, 23511798, 23793279, 23790773, 23693180,
19870236, 43802562
REASON: Blood products, which tested negative for antibody
to hepatitis C virus (anti-HCV), but collected from a donor that previously
tested repeatedly reactive, were distributed.
MANUFACTURER/RECALLING FIRM: Sera-Tec Biologicals
Limited Partnership, Toledo, Ohio
DISTRIBUTION: CA and NY
QUANTITY: 30 units
PRODUCT AND CODE: Red Blood Cells, units
42FW79310, 42Y10050; Platelets, unit 42Y10050; Recovered Plasma, unit 42Y10050
REASON: Blood products, collected from a donor taking the
drug Purinethol for Crohnís disease, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
DISTRIBUTION: OH and CA
QUANTITY: 4 units
PRODUCT AND CODE: Recovered Plasma, Frozen,
Unit 12FK28839
REASON: Blood product, collected from an unsuitable donor
based on a history of hepatitis, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Carolinas Region, Charlotte, NC
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, units
38624582, 38653087
REASON: Blood product, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed
MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center,
Corpus Christi, TX
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, unit 2105657
REASON: Blood product, collected from an ineligible donor,
was distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria,
OH
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
4168875; Fresh Frozen Plasma, unit 4168875
REASON: Blood products, collected from a donor with a
history of having tested positive for hepatitis B core antigen (anti-HBc), were
distributed.
MANUFACTURER/RECALLING FIRM: Blood Center of New
Jersey, East Orange, NJ
DISTRIBUTION: NJ
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
3567383; Platelets, unit 3567383; Source Leukocytes, unit 3567383
REASON: Blood products, collected from a donor who had
lived in an area designated as endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: TX and NJ
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
M30637; Platelets, unit M30637; Recovered Plasma, unit M30637
REASON: Blood products, collected from a donor who lived
in an HIV Group O risk area, were distributed.
MANUFACTURER: Michigan Community Blood Center, Saginaw
Valley Blood Program, Saginaw, Michigan
RECALL BY: Michigan Community Blood Center, Grand
Valley Blood Program, Grand Rapids, MI
DISTRIBUTION: MI and Switzerland
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, units
04C03680, 04C12090; Platelets, unit 04C12090; Recovered Plasma, units 04C03680,
04C12090
REASON: Blood products, collected from a donor who engaged
in high-risk behaviors, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, New
England Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, unit
FK23676; Cryoprecipitate, unit FK23676
REASON: Blood products, collected from a donor who was
taking the drug Amantadine for Parkinsonís disease, was distributed.
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services Inc., Rhode Island Blood Center, Providence, RI
DISTRIBUTION: RI and MS
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma, units
S0020R, S0021R, S0022R, S0023R, S0024R, S0021B, S0022, S0023, S0024
REASON: Blood products, which were exposed to an
unacceptable storage temperature and not relabeled as Source Plasma, Salvaged,
were distributed.
MANUFACTURER/RECALLING FIRM: Indianapolis Blood Plasma,
Inc., Indianapolis, IN
RECALL BY: Indianapolis Blood Plasma, Inc.,
Cincinnati, OH
DISTRIBUTION: NC
QUANTITY: 9 units
PRODUCT AND CODE: Platelet Pheresis,
Leukoreduced, unit 12LT50607
REASON: Unlicensed blood product was distributed in
interstate commerce.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Carolina Region, Charlotte, NC
DISTRIBUTION: SC
QUANTITY: 1 unit
WEEK ENDING AUGUST 11
PRODUCT AND CODE: Corneas for Transplant,
Tissue numbers 01-0148 OD and 01-0148 OS
REASON: Corneas, collected from a donor whose serum tested
positive for anti-HCV, and RIBA positive, were distributed.
MANUFACTURER/RECALLING FIRM: Northwest Lions Eye Bank,
Seattle, WA
DISTRIBUTION: CT and Germany
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 2822185
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Central California Blood
Center, Fresno, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells (4 units),
unit numbers 2862592, 2858158, 2853843, 2849093
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Central California Blood
Center, Fresno, CA
DISTRIBUTION: CA
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, unit
number GQ07568
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Centers of the
Pacific, Irwin Center, San Francisco, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced (3 units), unit numbers 90-45459, 90-45777, and 90-49037
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced (8 units), unit numbers 91-90458, 91-90454, 91-90457,
91-90467, 91-90453, 90-57179, 91-90461,
and 91-90450
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville,
TN
DISTRIBUTION: TN
QUANTITY: 8 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced (8 units), unit numbers 93-89662, 93-89664, 93-89668,
93-89669, 93-89670,
93-89663,
93-89665, and 93-89667
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 8 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Irradiated, unit numbers 93-87749 and 93-87780
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: Medic, Inc., Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 2 units
WEEK ENDING AUGUST 18
PRODUCT AND CODE: Platelets, Pheresis, Leukocytes
Reduced, Irradiated, Unit 4250783
REASON: The corresponding split unit of Platelets,
Pheresis, was implicated in a transfusion fatality, and was found to be
contaminated with Salmonella. The
second half of the unit had been distributed
MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman
Institute, dba Oklahoman Blood Institute, Oklahoma City, OK
DISTRIBUTION: OK
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, unit 53FM43909
REASON: Blood product, corresponding to a unit of
Leukoreduced Red Blood Cells, that were implicated in a transfusion reaction,
and found to be contaminated with Staphylococcus epidermidis, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Greater Chesapeake and Potomac Region, Baltimore, MD
DISTRIBUTION: MD
QUANTITY: 1 unit
PRODUCT AND CODE: Urokinase for Catheter
Clearance, 9000 IU per 1.8mL vial, units: 00I07017, 00I0401, 00I0101, 00H2101,
00H1401, 00H0701, 00G3101, 00G2401, 00G1701, 00G1001, 00F2901, 00F2601,
00F1901, 00E2401, 00E2201, 00E2001, 00E1001, 00E0801, 00D1701, 00D1501,
00D1301, 00D1101.
REASON: Product was not approved, and was manufactured
under conditions which were not in compliance with Current Good Manufacturing
Practices.
MANUFACTURER/RECALLING FIRM: The Medicine Shoppe,
Kingsport, TN
DISTRIBUTION: Nationwide
QUANTITY: 7000 vials
PRODUCT AND CODE: a)Red Blood Cells, units
S01983, S60252; b)Platelets, unit S60252; c)Recovered Plasma, units S01983,
S60252.
REASON: Blood products, collected from a donor who may
have been exposed to hepatitis, were distributed.
MANUFACTURER/RECALLING FIRM: Michigan Community Blood
Center, Saginaw Valley Blood Program, Saginaw,
MI
RECALLED BY: Michigan Community Blood Center, Grand
Valley Blood Program, Grand Rapids, MI
DISTRIBUTION: MI, NY and Switzerland
QUANTITY: 5 units
PRODUCT AND CODE: Source Plasma, units SA022283, SA761477, SA761447, SA761415,
SA761354, SA761253, SA761229, SA761151, SA761114, SA760958, SA760588, SA760567,
SA760388, SA760348, SA760287, SA760222, SA760187, SA760147, SA760118, SA760078,
SA760042, SA759964, SA759924, SA759733, SA759702, SA759344, SA759319, SA759144,
SA758931, SA758895, SA758709, SA758688, SA758630, SA758592, SA758392, SA758152,
SA758088, SA758074, SA757885, SA757868, SA757829, SA757684, SA757654, SA757624,
SA757519, SA757323, SA757311, SA757282, SA757273, SA757235, SA757197, SA757155,
SA757142, SA757093, SA757061, SA757055, 08005090, 07980237, 07978401, 07974007,
07972454
REASON: Blood products, collected from a donor who engaged
in high-risk behavior, were distributed.
MANUFACTURER/RECALLING FIRM: Sera Tec Biologicals
Limited Partnership, Pittsburgh, PA
RECALLED BY: Sera Tec Biologicals Limited Partnership,
North Brunswick, NJ
DISTRIBUTION: NC and MD
QUANTITY: 61
PRODUCT AND CODE: Red Blood Cells, unit
numbers 20FF10497, 20FF15841, 20FF23097, 20FF28779, 20FF31782, 20FF34935,
20FF43341, 20KM06807, 20LY01273, 20LZ01456, and 20LY03802; Platelets, unit
numbers 20FF10497, 20FF23097, and 20FF31782 ;Platelets for Manufacturing Use,
unit numbers 20FF15841, 20FF28779, 20FF34935, and 20FF43341; Recovered Plasma,
unit numbers 20FF10497, 20FF15841, 20FF23097, 20FF28779, 20FF31782, 20FF34935,
20FF43341, 20KM06807, 20LY01273, 20LZ01456, and 20LY03802
REASON: Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from a donor that
previously tested reactive to anti-HCV, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Lewis and Clark Region, Boise, ID
DISTRIBUTION: ID, Ca, TN and MT
QUANTITY: 29 units
PRODUCT AND CODE: Human tissue for
transplantation of the following types: Ilium Bicort Strip 22mm x 6.0cm, serial
numbers 034118130028 and 034118130029
Calcaneus
cross section 13-15mm, serial numbers 034118130038 and 034118130039
Cancellous
Block 3cm x 25mm x 25mm, serial number 034118130007
Iliac
Crest Wedge 13-15mm, serial numbers 034118130034, 034118130035, and
034118130036
Iliac
Crest Wedge 24-26mm, serial numbers 034118130030, 034118130031, and
034118130032
Fibula
Shaft 4cm, serial numbers 034118130015, 034118130016, and 034118130017
Fibula
shaft 8.0cm x 12-13mm, serial number 034118130021
Bone-Tendon-Bone,
Whole W/Quadricep, serial numbers 034118130068 and 034118130069
Femur
Proximal Right, serial number 034118130006
Cancellous
Chips 1.7-10mm, 90cc, serial numbers 034118130011, 034118130012, and
034118130013
REASON: Human tissues for transplantation were distributed
and were subsequently reported to have
tested repeatedly reactive for hepatitis B surface antigen (HBsAg).
MANUFACTURER/RECALLING FIRM: Musculoskeletal Transplant
Foundation, Edison, NJ
DISTRIBUTION: CA, WI, KA, MD, NY, SC, MA, AL, CO, IA, NJ,
TX
QUANTITY: 46 units
PRODUCT AND CODE: Red Blood Cells, units 3029608,
6308285; Platelets, unit 6308285; Fresh Frozen Plasma, unit 6308285; Recovered
Plasma, unit 3029608
REASON: Blood products, collected from a donor taking the
drug Methotrexate, were distributed.
MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL
DISTRIBUTION: IL
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, unit
6912790; Platelets, unit 6912790; Recovered Plasma, unit 6912790
REASON: Blood products, collected from a donor taking the
drug Methotrexate, were distributed.
MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL
DISTRIBUTION: IL
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 12FT89331; Recovered Plasma, unit 12FT89331
REASON: Blood products, collected from a donor who had
been exposed to an individual who is a hepatitis B carrier, were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Durham, NC
RECALLED BY: American Red Cross Blood Services,
Carolinas Region, Charlotte, NC
DISTRIBUTION: NC
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
2208030; Platelets, unit 2208030; Fresh Frozen Plasma, unit 2208030
REASON: Blood products, collected from a donor who had a
tattoo within twelve months of donation, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria,
OH
DISTRIBUTION: OH, SC, CA
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 01Y33686
REASON: Blood product, which was mislabeled as CMV
antibody negative, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, New York-Penn Region, West Henrietta, NY
DISTRIBUTION: NY
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, units
G38368-195, G37872-195, G37480-195
REASON: Blood products, collected from a donor who had
been incarcerated, were distributed.
MANUFACTURER/RECALLING FIRM: Alpha Therapeutic
Corporation - SNA, San Antonio, TX
DISTRIBUTION: NC
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma, units
7030120944, 7030120804, 7030120322
REASON: Blood products, collected from a donor who was at
increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were
distributed.
MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center,
San Antonio, TX
DISTRIBUTION: United Kingdom
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma, unit
28389224
REASON: Blood products, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed.
MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center,
Dallas, TX
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit 04LE21445; Platelets, unit 04LE21445
REASON: Blood products, collected from a donor who
reported having lived in an area designated as endemic for malaria, were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, New
England Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit number FJ60026
REASON: Blood product, collected from a donor whose hemaglobin/hematocrit
had not been documented, was distributed.
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services Inc., dba Rhode Island Blood Center,
Providence, RI.
DISTRIBUTION: R.I.
QUANTITY 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, unit numbers 5091112
REASON: Blood product, that tested negative for the
antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor
that previously tested repeatedly reactive for anti-HBc on more than one
occasion, was distribution.
MANUFACTURER/RECALLING FIRM: Coffee Memorial Blood
Center, Amarillo, TX
DISTRIBUTION: TX
QUANTITY 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit FM28100
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services Inc., Providence, RI
DISTRIBUTION: R.I.
QUANTITY 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 13FY60963
REASON: Blood product, collected from a donor taking the
drug Mercaptopurine, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Detroit, MI
DISTRIBUTION: MI
QUANTITY 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
numbers 4318293 and 4304784; Platelets, unit numbers 4318293 and 4304784;
Recovered Plasma, unit numbers 4318293 and 4304784
REASON: Blood products, that tested negative for
hepatitis, but were collected from an unsuitable donor based on previous
reactive hepatitis testing, were distributed.
MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL
DISTRIBUTION: IL and Scotland
QUANTITY: 6 units
PRODUCT AND CODE: Red Blood Cells, unit
number 3809592; Cryoprecipitated AHF, unit number 3809592; Recovered Plasma,
unit number 3809592
REASON: Blood products, that tested negative for
hepatitis, but were collected from an unsuitable donor based on previous
reactive hepatitis testing, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Permian Basin Blood Institute, Midland, TX
DISTRIBUTION: TX and CA
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
numbers 5133770, 3770099 (2 spilt units distributed), and 3749496
Red
Blood Cells, Leukocytes Reduced, unit number 3710443
Cryoprecipitated
AHF, unit number 5133770
Fresh
Frozen Plasma, unit number 3749496
Recovered
Plasma, unit number 3710443
REASON: Blood products, that tested negative for
antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), and
antibody to hepatitis C virus (anti-HCV), but were collected from donors that
previously tested repeatedly reactive to anti-HIV or anti-HCV, were
distributed.
MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman Center,
Oklahoma Blood Institute, Oklahoma City, OK
DISTRIBUTION: TX and Switzerland
QUANTITY: 8 units
PRODUCT AND CODE: Red Blood Cells, unit
number 24KM58751; Platelets, unit number 24KM58751; Fresh Frozen Plasma, unit
number 24KM58751
REASON: Blood products, that tested negative for
hepatitis, but were collected from an unsuitable donor based on previous reactive
hepatitis testing, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, River Valley Region, Louisville, KY
DISTRIBUTION: KY
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
number 24GV11630; Recovered Plasma, unit number 24GV11630
REASON: Blood products, that tested negative for
hepatitis, but were collected from an unsuitable donor based on previous
reactive hepatitis testing, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, River Valley Region, Louisville, KY
DISTRIBUTION: IN and CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 50C04091
REASON: Blood product, collected from an unsuitable donor based
on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Western Lake Erie Region, Toledo, OH
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 50LH14269
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Western Lake Erie Region, Toledo, OH
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 50X14779
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Western Lake Erie Region, Toledo, Ohio
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 16LY92081
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Central Ohio Region, Columbus, OH
DISTRIBUTION: OH
QUANTITY 1 unit
PRODUCT AND CODE: Platelets Pheresis (7
units), unit numbers 7574655, 7574489, 7575312, 7575177, 7574876, 7574698, and
7574218
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY 7 units
PRODUCT AND CODE: Red Blood Cells, unit
numbers 2131157 and 2132484; Platelets, unit numbers 2131157 and 2132484
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria,
OH
DISTRIBUTION: OH and CA
QUANTITY: 4 units
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, unit numbers C14075C and C14075D
REASON: Blood products, collected from an ineligible donor
due to medication with Furosemide (Lasix), were distributed.
MANUFACTURER/RECALLING FIRM: Tacoma-Pierce County Blood
Bank, Cascade Regional Blood Services, Tacoma, WA
DISTRIBUTION: AZ and NY
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 7558728
REASON: Blood product, collected from a donor who had
traveled to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
5084104
REASON: Blood product, collected from a donor whose
hemaglobin had not been documented, was
distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
24KC22025; Platelets, unit 24KC22025; Fresh Frozen Plasma, unit 24KC22025
REASON: Blood products, collected from a donor who was
taking an experimental drug, were distributed.
MANUFACTURER/RECALLING FIRM: American National Red
Cross Blood Services, River Valley Region, Louisville, KY
DISTRIBUTION: IN and KY
QUANTITY: 3 units
PRODUCT AND CODE: Fresh Frozen Plasma, unit
24FH25076
REASON: Unit of Platelets, implicated in a transfusion reaction,
were found to be contaminated with coagulase-negative staphylococcus. A corresponding blood product was
distributed.
MANUFACTURER/RECALLING FIRM: American National Red
Cross Blood Services, Louisville, KY
DISTRIBUTION: KY
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, units 0024113, 0024467, 0024885
REASON: Blood products, collected from a donor who was at
increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were
distributed
MANUFACTURER/RECALLING FIRM: DCI Biologicals Bryan, Inc.,
Bryan, TX
DISTRIBUTION: Austria
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
C17422
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, units
0015571, 0017611, 0017991, 0018359, 0018769, 0019891, 0020385, 0021749,
0022197, 0022305, 0022765, 0023327, 0023437, 0024685, 0024784, 0025062, 025200,
0026567,0026949, 0027592, 0027852, 0028217, 0028485
REASON: Blood products, collected from an unsuitable
donor, were distributed
MANUFACTURER/RECALLING FIRM: DCI Biologicals Bryan,
Inc., Bryan, TX
DISTRIBUTION: Austria
QUANTITY: 23 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit FG37427; Platelets,
unit FG37427; Fresh Frozen Plasma,
unit FG37427
REASON: Blood products, collected from a donor whose body
temperature had not been documented, were distributed.
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services Inc., Providence, RI
DISTRIBUTION: R.I.
QUANTITY: 3 units
PRODUCT AND CODE: Platelet Pheresis,
Leukoreduced, unit 04GH05165
REASON: Blood product, inappropriately prepared by recording
the incorrect volume on the label, which resulted in the product being
distributed in one platelet bag instead of two.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Dedham, MA
DISTRIBUTION: MA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
2209341; Platelets, unit 2209341
REASON: Blood Products, collected from a donor whose
suitability was not adequately determined, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria,
Ohio
DISTRIBUTION: OH
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
0333642; Red Blood Cells Leukoreduced, unit 0323125; Platelets, unit 0323125
REASON: Blood products, collected from a donor who
reported travel to an area designated as endemic for malaria, were
distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas, Kansas City, MO
DISTRIBUTION: MO
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma, units 01GMIA7860, 01GMIA8157, 01GMIA8936, 01GMIA9230,
01GMIA9961, 01GMIB0273, 01GMIB1037, 01GMIB1354, 01GMIB2108, 01GMIB2425
REASON: Blood products, collected from a donor who had
been incarcerated, were distributed.
MANUFACTURER: Community Bio-Resources, Inc., Grand
Rapids, MI
RECALLED BY: Community Bio-Resources, Inc., Hoover,
Alabama
DISTRIBUTION: Austria
QUANTITY: 10 units
PRODUCT AND CODE: Red Blood Cells, unit
21KK18590
REASON: Blood product that was not quarantined after receiving
information concerning a post donation illness, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Southern Region, Atlanta, GA
DISTRIBUTION: SC
QUANTITY: 1 unit
PRODUCT AND CODE: Collagenase, Santyl
Ointment, Lots 0000067143, 0000067144
REASON: Subsequent to release, the product was found to
exceed the potency specification.
MANUFACTURER/RECALLING FIRM: Advance Biofactures
Corporation, a subsidiary of Biospecifics Technologies Corporation, Lynbrook,
NY
DISTRIBUTION: Nationwide
QUANTITY: 19,548 tubes were distributed
PRODUCT AND CODE: Roferon-A Injection,
Interferon alfa-2a, recombinant, Prefilled Syringes, 9 Million IU/0.5 mL per
syringe, Lots 2003, 2003-02 - Expiration dates 10/2000
REASON: During the 12 month stability testing of the
product, an interferon degradant was found.
MANUFACTURER: F. Hoffmann La Roche Ltd., Basel,
Switzerland
RECALLED BY: Hoffmann La Roche, Inc., Nutley, NJ
DISTRIBUTION: Nationwide
QUANTITY: 8,011 vials distributed
PRODUCT AND CODE: Reagent Red Blood Cells,
Coombs Control Cells (Strong), Lot 0508299, expired June 13, 2001
Reagent
Red Blood Cells, Screening Duet, Lot 0502304, expired June 13, 2001
Reagent
Red Blood Cells, Complement Coombs Control (EC3b), Lot 0529344, expires July 4,
2001
REASON: Reagent Red Blood Cells, which may hemolyze
prematurely due to microbial contamination, were distributed.
MANUFACTURER/RECALLING FIRM: Gamma Biologicals, Inc.,
Houston, TX
DISTRIBUTION: Nationwide
QUANTITY: 3 lots
PRODUCT AND CODE: Fresh Frozen Plasma, unit
91-90588
REASON: Blood product, prepared from a unit of Whole Blood
with a documented extended collection time, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 95-35180
REASON: Red Blood Cells, leukoreduced by filtration
greater than five days past the time of collection, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
units 12Q80995, 12M69417
REASON: Blood products, collected from a donor with a
history of Idiopathic Thrombocytopenic Purpura, were distributed
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Charlotte, NC
DISTRIBUTION: NC
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
C29094
REASON: Blood product, collected from a donor whose arm
inspection had not been documented, was distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
FJ49829
REASON: Blood product, labeled with an extended expiration
date, was distributed.
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services Inc., Providence, RI 02908
DISTRIBUTION: R.I.
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
numbers 3730382, 3770991, 5140574, and 5140864 (2 spilt units distributed)
Red
Blood Cells, Leukocytes Reduced, unit number 3770770
Cryoprecipitated
AHF, unit number 5140574
Fresh
Frozen Plasma, unit number 5136402
Recovered
Plasma, unit number 3730382
REASON: Blood products, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), and antibody to
hepatitis C virus (anti-HCV), but were collected from donors that previously
tested repeatedly reactive to anti-HIV or anti-HCV, were distributed.
MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman Center,
Oklahoma City, OK
DISTRIBUTION: TX and Switzerland
QUANTITY: 9 units
PRODUCT AND CODE: Fresh Frozen Plasma (23
units), unit numbers 50C06082, 50C06085, 50C06086, 50C06088, 50C06089,
50C06090, 50C06092, 50C06093, 50C06095, 50C06096, 50C06097, 50C06099, 50C06100,
50C06103, 50C06104, 50C06105, 50C06106, 50C06107,
50C06109,
50LH18742, 50LH18745, 50LH18746, and 50LH18748
REASON: Blood products, manufactured using a centrifuge
that was found to be at an incorrect temperature, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Toledo, OH
DISTRIBUTION: OH
QUANTITY: 23 units
PRODUCT AND CODE: Recovered Plasma, unit
LL62466
REASON: Blood product, that was not quarantined after
receiving information concerning a post donation illness, was distributed.
MANUFACTURER/RECALLING FIRM: Mid-South Regional Blood
Center, Memphis, TN
DISTRIBUTION: FL
QUANTITY: 1 unit
WEEK ENDING AUGUST 25
PRODUCT AND CODE: Red Blood Cells, Autologous,
units 7583781, 7537250
REASON: Blood products, collected from donors whose
hematocrit had not been performed, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 2 units