JUNE 2002
WEEK ENDING JUNE 1
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number C46225.
RECALLING FIRM/MANUFACTURER South Bend Medical
Foundation, Inc., Central Blood Bank, South Bend, IN
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 IN.
PRODUCT Platelet, Pheresis.
CODE Unit K20252.
RECALLING FIRM/MANUFACTURER Recalling Firm: Mississippi
Valley Regional Blood Center,
Davenport, IA
REASON Blood product, which had a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells.
CODE Units S11408, S11410, S11411, S11412, S11413,
S11414, S11420, S11421, S11425, S11428, S11429, S11430, S11432, S11436, S11442,
S11444, S11445, S11446, S11447, S11448, S11449, S11451, S11452, S11456, S11458,
S11462, S11463, S11465, S11466, S11467, S11468, S11470, S11474, S11476, S11478,
S11480, S11482, S11483, S11485, S11487, S11490, S11493, S11497, S11499, S11506,
S11508, S11510, S11514.
RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan Community Blood Centers, Grand
Valley Blood Program, Grand Rapids, MI
Manufacturer:
Michigan Community Blood Centers, Saginaw, MI.
REASON Blood products, collected from a donor whose
hemoglobin was unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE 48 units.
DISTRIBUTION MI.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated
CODE Unit number 01GK19138 (distributed as two split
units).
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, New York-Penn Region, West Henrietta, NY
Manufacturer: The American National Red Cross, New
York-Penn Region, Syracuse, NY.
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 NY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 17195-0076.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
McAllen, TX
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 TX.
PRODUCT Red Blood Cells
CODE Unit number 6401476.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
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 IL.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number H62115.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
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 IA.
PRODUCT Red Blood Cells.
CODE Unit number V95530.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
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
CODE Unit number N52125.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
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 IL.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a); b) and c) Unit number 2448450.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
REASON Blood products, collected from a donor who should
have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Unit number N-51595-072.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp.,
Long Beach, CA
REASON Blood product, that tested negative for viral
markers, but was collected from a donor that previously tested reactive for a
viral marker, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers 15387-2445, 15389-4681, 15011-6796,
15011-7710, 15011-7851, 15011-7931, 15011-8269, 15012-2838, 15012-4682,
15012-4888, 15012-5269, 15012-6900, 15012-6923, 15013-0059, 15386-4194,
15386-4666, 15387-5270, 15387-6874, 15388-2342, 15388-6031, 15388-8240,
15388-9162, 15389-1057, 15389-3858, 15389-6179, and 15390-0496.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Lubbock,
TX
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 26 units.
DISTRIBUTION TX.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Unit K21759.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
REASON Blood product, labeled as leukoreduced but did not
have white blood cell count determination, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Unit 17196-3292.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
McAllen, TX
REASON Blood product, incorrectly labeled as leukoreduced,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.
PRODUCT Red Blood Cells
CODE Unit number T61875.
RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan
Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI
Manufacturer:
Michigan Community Blood Centers, Traverse City, MI.
REASON Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 17196-0442.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
McAllen, TX
REASON Blood product, labeled with the incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 11325-4060, 11325-4059, 11325-4058,
11325-4057, 11325-4056, 11325-4055, 11325-4054, 11325-4053, 11325-4052, and
11325-4051.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El
Paso, TX
REASON Unlicensed blood products were distributed
interstate.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION NM.
WEEK
ENDING JUNE 8
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Units 12FG83592, 12FR73622.
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Source Plasma
CODE Units 58991008, 57110813, 57108582.
RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife
Plasma Services, L.P., North Brunswick, NJ
Manufacturer:
Biolife Plasma Services, L.P., Louisville, KY.
REASON Blood products, collected from a donor who tested
positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 29941704, 28489504.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec
Biologicals Limited Partnership, North Brunswick, NJ
Manufacturer:
Sera-Tec Biologicals Limited Partnership, Toledo, OH
REASON Blood products, collected from a donor who tested
positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 29944910.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec
Biologicals Limited Partnership, New Brunswick, NJ
Manufacturer: Sera-Tec Biologicals Limited Partnership,
Toledo, OH
REASON Source Plasma, with an elevated alanine
aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit 1849482.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Blood products, collected from a donor who had a
tattoo applied within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY and NJ.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Cryoprecipitate
CODE a) and b) Unit H60999.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
REASON Blood products, which tested negative for anti-HCV,
but were collected from a donor who provided post donation information
regarding previously testing indeterminate for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL and NC.
PRODUCT Capture-P Ready Screen Kit (Platelet Antibody
Detection System),
CODE Lot Number 06996; expiration date March 8, 2002.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Test kits were incorrectly packaged with Capture-P
Ready Screen 1-test strips, instead of 6-test plates.
VOLUME OF PRODUCT IN COMMERCE 61 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Platelets, Pheresis
CODE Unit 7400918.
RECALLING FIRM/MANUFACTURER Manatee Community Blood
Centers, Inc., Bradenton, FL
REASON Blood product, collected from a donor who had the
oral typhoid immunization, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Units 21381-8437, 21381-9338, 21381-9340,
21382-0020, 21382-0034, 21382-0243, 21382-0549, 21382-0752
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
United Blood Services, Fargo, ND.
REASON Red Blood Cells, with incomplete compatibility
testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION ND.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma
CODE a) and b)Unit number 3799828.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 2 units.
DISTRIBUTION FL and NJ.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated,
CODE Unit number 01LZ23852
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New
York-Penn Region, West Henrietta, NY
Manufacturer:
American Red Cross Blood Services, New York-Penn Region, Buffalo, NY.
REASON Blood product, corresponding to a unit of Platelets
that was possibly contaminated with coagulase negative Staphylococcus sp.
bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Source Plasma
CODE Unit numbers 306U9118AB, 306U9138AB, 306U9157AB,
306U9178AB, 306U9178AB, 306U9204AB, 306U9237AB, 306U9254AB, 306U9283AB,
306U9401AB, 306U9415AB, 306U9751AB, 306U9764AB, 306U9797AB, 306U9810AB,
303FR731AB, 306U9651AB, 306U9659AB, 306U9669AB, 306U9676AB, 306U9684AB,
306U9695AB, 306U9716AB, 306U9740AB, 306U9871AB, 306U9885AB, 306U9902AB, and
306U9910AB.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Lincoln, NE
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 27 units.
DISTRIBUTION IL and Germany.
PRODUCT Capture-P? Solid Phase Test System
CODE Lot number 10098.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Test for antibodies to platelets were distributed
with a component that expired prior to the labeled expiration date of the kit.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION Nationwide and Europe.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Fresh Frozen
Plasma; c) Red Blood Cells, for Manufacturing Use Only; d) Recovered Plasma
CODE a) and b) Unit 0680866; c) and d) Unit 0733361.
RECALLING FIRM/MANUFACTURER Memorial Blood Center,
Minneapolis, MN
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MN, MI and PA.
PRODUCT a) Platelet, Pheresis, Leukoreduced; b) Platelet,
Pheresis, Leukoreduced Irradiated; c) Red Blood Cells;
d)
Platelets; e) Fresh Frozen Plasma
CODE a) Units 32KP20191(Split), 32KP20106(Split),
32KP19540; b) Unit 32KP19540; c); d) and e) Unit 32KC15534.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Badger-Hawkeye Region, Madison, WI
REASON Blood products, which tested negative for anti-HCV,
but were collected from a donor who provided post donation information
regarding previously testing indeterminate for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION IL, WI and OH.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets, Leukocytes Reduced
CODE a) and b)Unit number 17KN79755.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, North Central Region, St. Paul, MN
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 MN.
PRODUCT Red Blood Cells
CODE Unit number G82310.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
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 FL.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number K16225.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IA.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number 1829221.
RECALLING FIRM/MANUFACTURER Siouxland Community Blood
Bank, Sioux City, IA
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 4092505.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Dayton, OH
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 OH.
PRODUCT Red Blood Cells
CODE Unit number 1110704.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Dayton, OH
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 OH.
PRODUCT Red Blood Cells
CODE Unit number 0667778.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center,Cincinnati, OH.
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells
CODE Unit number 0667882.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 16GV00070 and 16KC17218.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Central Ohio Region, Columbus, 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.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit.number 32GP13860.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Badger-Hawkeye Region, Madison, WI
Manufacturer:
The American National Red Cross, Green Bay, WI
REASON Blood product, corresponding to a unit of Platelets
that was possibly contaminated with Clostridium sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 17KW30862.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, North Central Region, St. Paul, MN
REASON Blood products, corresponding to a unit of Platelets
that was possibly contaminated with coagulase negative Staphylococcus sp.
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MN and NY.
PRODUCT Red Blood Cells
CODE Unit number 1776051.
RECALLING FIRM/MANUFACTURER Siouxland Community Blood
Bank, Sioux City, IA
REASON Blood product, collected from an ineligible donor
due to medication with the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SD.
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c)
Plasma
CODE a); b) and c) Unit number 32KE15914.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Badger-Hawkeye Region, Madison, WI
REASON Blood products, that tested negative for viral
markers, but were collected from an unsuitable donor due to the application of
a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IL and WI.
PRODUCT Source Plasma
CODE Unit numbers 33-3LM111, 33-3KJ644, 33-3KJ693,
33-3KJ835, 33-3KJ901, 33-3KK021, 33-3KK120, 33-3KK181, 33-3KK317, 33-3KK378,
33-3KK591, and 33-3KK668.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis
Bio-Services, Inc., Knoxville, TN
Manufacturer:
Aventis Bio-Services, Inc., West Allis, WI.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor due to illegal drug use,
were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION Germany and France.
PRODUCT Source Plasma
CODE Unit numbers 6R4734, 6R4789, 6R4944, 6R5014, 6R5215,
6R5304, 6R5378, and 6R5446.
RECALLING FIRM/MANUFACTURER Recalling Firm: Centeon
Bio-Services, Inc., Knoxville, TN
Manufacturer:
Aventis Bio-Services, Inc. (formerly Centeon Bio-Services, Inc.), Minneapolis,
MN.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor due to illegal drug use,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Unit numbers 8W8065, 8W8131, 8W8274, 8W8353, and
8W8525.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis
Bio-Services, Inc., Knoxville, TN
Manufacturer:
Aventis Bio-Services, Inc., Minneapolis, MN.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor due to illegal drug use,
were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Unit number 46724106.
RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS
REASON Blood product, that was not properly quarantined
after the donor disclosed previous incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit number 21744068.
RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate
Blood Bank, Inc., Memphis, TN
Manufacturer:
Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI.
REASON Blood product, that was not properly quarantined
after the donor disclosed previous incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit numbers 09293403, 08386618, 07837548, 07832291,
06949112, 0650222172, 0650222136, 0650222069, and 0650222011.
RECALLING FIRM/MANUFACTURER Recalling Firm: Nabi, Boca
Raton, FL
Manufacturer:
ZLB Bioplasma, Inc. (formerly Nabi), Racine, WI.
REASON Blood products, collected from an ineligible donor
due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION CA.
PRODUCT Platelet, Pheresis
CODE Unit 22KG42465, 22KG42467.
RECALLING FIRM/MANUFACTURER American Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood products, labeled with extended expiration
dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells; b) Platelets Pheresis; c)
Platelets Pheresis, Leukocytes Reduced
CODE a) Unit number 15 009-2350 (distributed as 2 split
units); b) Unit numbers 15006-0519, 15006-8357, 15379-1924, 15380-9311, and
15006-0408;
c) Unit numbers 15012-6382, 15386-3886, 15386-8101, 15386-8251, 15386-8561,
15387-1182, 15387-1726, 15387-1859, 15387-4449, and
15387-9358.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, collected from an ineligible donor
due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION TX.
PRODUCT Indicator Red Cells
CODE Lot numbers 08006, 08007, and 08046, used in the
following test kits: Capture-P? Test System, lot number 08038; Capture-P?
Ready-Screen? Test System, lot numbers 08040 and 08041; Modified Capture-P?
Test System, lot number 08039; Capture-CMV? Test System, lot numbers 08042,
08043, and 08043A; and Capture-S? Test System, lot numbers 08044, 08045, and
08045A.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Test kits were distributed with indicator cells that
may experience a loss of potency.
VOLUME OF PRODUCT IN COMMERCE 3 lots.
DISTRIBUTION Europe.
PRODUCT Capture-R? Ready-Screen? Test System
CODE Lot numbers 37034 and 37035.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Test kits were distributed that exhibited an increase
in false positive tests.
VOLUME OF PRODUCT IN COMMERCE 2 lots.
DISTRIBUTION Nationwide, Europe, Canada and Australia.
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma
CODE a); b) and c) Unit number G70777.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional
Blood Center, Davenport, IA
REASON Blood products, collected from an ineligible donor
due to a history of surgery in the previous 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IA, MO and Switzerland.
PRODUCT Recovered Plasma
CODE Unit number 17KW30862.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, North Central Region, St. Paul, MN
Manufacturer:
The American Red Cross, St. Paul, MN.
REASON Blood product, corresponding to a unit of Platelets
that was possibly contaminated with Clostridium sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukocytes Reduced Washed
CODE Unit numbers 24212-7084 and 24212-7096.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
Blood Systems, Inc., Rapid City, SD.
REASON Blood products that were out of controlled storage
for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION SD.
PRODUCT Source Plasma
CODE Unit numbers 00LWID6857, 00LWID7203, 00LWID7848,
00LWID8397, 00LWID8903, 00LWIE0334, 00LWIE0584, 00LWIE1456, 00LWIE1925,
00LWIE2585, 00LWIE3071, 00LWIE3709, and 0LWIE4186 .
RECALLING FIRM/MANUFACTURER Recalling Firm: Community
Bio-Resources, Inc., Hoover, AL
Manufacturer:
Community Bio-Resources, Inc., Onalaska, WI.
REASON Blood products, collected from an ineligible donor due
to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION Austria.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Units 40FP12757, 40FP127562 (Split unit), 40P82325
(Split unit), 40P82328.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red
Cross Blood Services, Badger-Hawkeye Region, Madison, WI
Manufacturer: American Red Cross Blood Services, Heart of
America Region, Peoria, IL.
REASON Blood products, which were stored at unacceptable temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.
WEEK ENDING JUNE 15
PRODUCT Red Blood Cells
CODE Unit C81380.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood product, collected from a donor whose
Hemoglobin level was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Red Blood Cells
CODE Unit C51957.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood product, collected from a donor whose
hemoglobin level was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit
07FJ60559.
RECALLING FIRM/MANUFACTURER American Red Cross, Arizona
Region, Tucson, AZ
REASON Blood product, collected from a donor who lived in
an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit C64932.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit C56373.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood products, collected from a donor who reported travel
to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma
CODE a), b) and c) Units
H53631, H74401.
RECALLING FIRM/MANUFACTURER Regional Health Resource
Center, Community Blood Services of IL, Urbana, IL
REASON Blood products, collected from a donor who had
engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL, TX and CA.
PRODUCT Platelets Pheresis, Leukoycytes Reduced
CODE Unit J17098.
RECALLING FIRM/MANUFACTURER Recalling Firm: Regional Health Resource Center, Community
Blood Services of IL, Urbana, IL
REASON Blood product, collected in an unsuitable manner,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Source Plasma
CODE Units BTHDGR, BTHDQW, BTHFPH, BTHXSM, BTHYQK,
BTJZBR, BTHZYV, BTJBKY, BTJCDN, BTJCRP, BTHHYK.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis
Bio-Services, Inc., Knoxville, TN
Manufacturer:
Aventis Bio-Services, Inc., Dayton,
OH.
REASON Blood products, collected from a donor who engaged
in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION IL and Germany.
PRODUCT Red Blood Cells
CODE Unit T35600.
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Centers, Grand Valley Blood Program, Grand Rapids, MI
REASON Blood product, collected from a donor with a history
of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b)Unit Z72725.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood products, drawn from an unsuitable donor who
immigrated from a HIV group O high risk country, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit KK36497.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San
Diego, CA
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 CA.