SEPTEMBER 2001
WEEK ENDING SEPTEMBER 1
PRODUCT AND CODE: Red Blood Cells, Unit
KK14666
REASON: Blood product, collected in a bag that may have
had a puncture hole, was distributed.
MANUFACTURER/RECALLING FIRM: Sacramento Medical
Foundation Blood Center, Sacramento, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Carticel (Autologous
Cultured Chondrocytes), Lot CC00335
REASON: Tissue repair product, contaminated with
Corynebacterium, was distributed.
MANUFACTURER/RECALLING FIRM: Genzyme Biosurgery ,
Cambridge, MA
DISTRIBUTION: Norway
QUANTITY: 1 unit
PRODUCT AND CODE: Corneas for Transplant,
Tissue ID # 01-0637, 01-0638
REASON: Corneas, from a donor who tested reactive for the
HIV p24 antigen, with a negative Western Blot, by another donor procurement
organization, were distributed.
MANUFACTURER/RECALLING FIRM: Georgia Eye Bank, Inc.,
Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
5074564; Platelets, Unit 5074564; Recovered Plasma, Unit 5074564
REASON: Blood products, which tested negative for the
antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected
from a donor who previously tested repeatedly reactive for the antibody, with a
negative confirmatory test, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: Texas and Switzerland
QUANTITY: 3 units
PRODUCT AND CODE: Platelets, Pheresis, Unit
1662747
REASON: Blood product, collected from a donor who may have
traveled to an area designated as endemic for malaria, was distributed
MANUFACTURER/RECALLING FIRM: Blood Center of New
Jersey, Inc., East Orange, NJ
DISTRIBUTION: NJ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 0331587
REASON: Drug product, collected from a donor whose spouse
had a history of intravenous drug use, was distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas, Kansas City, MO
DISTRIBUTION: MO
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
38L59729; Recovered Plasma, Unit 38L59729
REASON: Blood products, collected from a donor with a
history of jaundice, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Fort Wayne, IN
DISTRIBUTION: CA, NY
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
E12522
REASON: Autologous Red Blood Cells, which tested repeat
reactive for anti-HCV, with a negative RIBA, was not labeled with a Biohazard
label.
MANUFACTURER/RECALLING FIRM: St. Elizabeth Health
Center, Youngstown, OH
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Corneas for Transplant,
Tissue ID numbers: 99-085(OD), 99-086
(OS), 99-333 (OD), 99-334 (OS), 99-431 (OD), 99-432 (OS), 99-0565 (OD), 99-0566
(OS), 99-0735 (OD), 99-0736 (OS), 00-003 (OD), 00-004 (OS), 00-0239 (OD),
00-0240 (OS)
REASON: Corneas, from donors who tested repeatedly
reactive for either anti-HBc, CMV, HBsAg, and/or the HIV p24 antigen, by
another donor procurement organization, were distributed.
MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Central
Texas, Austin, TX
DISTRIBUTION: CA, TX and MO
QUANTITY: 14
PRODUCT AND CODE: Reagent Red Blood Cells;
Surgiscreen; Lot # 3SS223; Expiration: 6 February, 2001.
REASON: Reagent red blood cells (1, 2 and 3), may lack the
E antigen necessary for antibody detection.
MANUFACTURER/RECALLING FIRM: Ortho Clinical
Diagnostics, Raritan, NJ
DISTRIBUTION: Nationwide and Japan
QUANTITY: 402 packages
PRODUCT
AND CODE: Corneas for Transplant, Donor ID #2001-06-3061, 2001-06-3062
REASON: Corneas, from a donor who tested repeat reactive
for anti-HBc, were distributed.
MANUFACTURER/RECALLING FIRM: Heartland Lions Eye Banks,
Columbia, MO
DISTRIBUTION: Missouri
QUANTITY: 2 Units
PRODUCT AND CODE: Corneas for Transplant,
Donor ID #2001-06-3051, 2001-06-3052
REASON: Corneas, from a donor who tested repeat reactive
for anti-HBc, were distributed.
MANUFACTURER/RECALLING FIRM: Heartland Lions Eye Banks,
Columbia, MO
DISTRIBUTION: MO and Cincinnati
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
1635942; Cryoprecipitate Reduced Plasma, Unit 1635942; Cryoprecipitate AHF,
Unit 1635942
Platelets,
Unit 1635942
REASON: Blood products, collected from a donor with a
history of having tested positive for Hepatitis C, were distributed.
MANUFACTURER/RECALLING FIRM: South Texas Blood &
Tissue Center, San Antonio, TX
DISTRIBUTION: TX
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, Units
H82822, H84757
REASON: Blood products, collected from a donor who
reported travel to an area designated as endemic for malaria, were
distributed.
MANUFACTURER/RECALLING FIRM: Regional Health Resource
Center, Urbana, Illinois
DISTRIBUTION: IL
QUANTITY: 2 units
PRODUCT AND CODE:
Red
Blood Cells, Unit 7000902
REASON: Blood product, collected from a donor whose
hemoglobin had not been documented, was distributed.
MANUFACTURER/RECALLING FIRM:New York Blood Center,
Elmsford, NY
RECALLED BY: New York Blood Center (Center West), New
York, NY
DISTRIBUTION: NY
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma Units
0024973, 0029810, 0031062, 0034881, 0036101, 0037516, 0025336, 0030000,
0035083, 0036514, 0037937, 0028849, 0030473, 0034258, 0035476, 0036639,
0038126, 0029256, 0030676, 0034459, 0035911, 0037228 (22 units)
REASON: Blood products, collected from a donor who had an
accidental mucous membrane exposure to blood, were distributed.
MANUFACTURER/RECALLING FIRM: DCI Biologicals, Wichita
Falls, Inc., Wichita Falls, TX
DISTRIBUTION: Vienna
QUANTITY: 22 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 16LY91798; Fresh Frozen Plasma, Unit 16LY91798
REASON: Blood product, collected from a donor with a
history of having tested positive for Hepatitis C, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Columbus, OH
DISTRIBUTION: OH and CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
7028859
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Department of the Air
Force, Keesler Air Force Base, MS
DISTRIBUTION: MS
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit FG64423
REASON: Blood product, which were mislabeled as CMV
antibody negative, was distributed.
MANUFACTURER:
Central Blood Bank, Pittsburgh, PA
RECALLED BY: Institute for Transfusion Medicine Clinical
Services, Pittsburgh, PA
DISTRIBUTION: PA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis, (Part
II) Unit 0811723
REASON: Blood product, which had a high platelet count,
was distributed.
MANUFACTURER/RECALLING FIRM: Blood Centers of the
Pacific, San Francisco, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis,
Leukoreduced, Unit 0802164
REASON: Blood product, collected from a donor who had a
tattoo within twelve months of donation, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Centers of the
Pacific, San Francisco, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
04N90126
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Dedham, MA
DISTRIBUTION: MA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
04KK38740
REASON: Blood product, collected from a donor who had
lived in an area designated as endemic for malaria, was distributed
MANUFACTURER/RECALLING FIRM: American Red Cross, New
England Region, Dedham, MA
DISTRIBUTION: VT
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
04FR43766
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, New
England Region, Dedham, MA
DISTRIBUTION: NY
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Irradiated, Leukoreduced, Unit C43197
REASON: Blood product, for which documentation of
irradiation was incomplete, was distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
6756870
REASON: Blood product, collected from a donor who had
traveled to an area designated as endemic for malaria, was distributed
MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers,
Lake Charles, LA
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
9520966; Recovered Plasma, Unit 9520966
REASON: Blood product, collected from a donor whose
partner had lived in an area at increased risk for HIV Group O, was
distributed.
MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers,
Lake Charles, LA
DISTRIBUTION: TX and CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
9514753
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers,
Lake Charles, LA.
DISTRIBUTION: LA
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, Units
27721766, 29710898
REASON: Blood products, which tested positive for
syphilis, were distributed.
MANUFACTURER/RECALLING FIRM: Sera-Tec Biological
Limited Partnership, Odessa, Texas
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Cephalothecium (ALK),
Trichothecium roseum, Lot B1016179
REASON: Allergenic extract labeled as Cephalothecium
(ALK), Trichothecium roseum, 10 M/L 1:20 w/v, was prepared from Cephalosporium
acremonium (ALK), 1:20 w/v.
MANUFACTURER/RECALLING FIRM: Allergy Laboratories of
Ohio, Inc., Columbus, OH
DISTRIBUTION: IN
QUANTITY: 1 lot
PRODUCT AND CODE: Platelets, Unit 3922122
REASON: Blood product, collected from a donor who had a
history of high risk behavior, was distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, Texas
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
03S06681; Recovered Plasma, Unit 03S06681
REASON: Blood product, collected from a donor who had a
history of high risk behavior, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Atlanta, GA
DISTRIBUTION: VA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Units
15009-0540, 15006-9967; Fresh Frozen Plasma, Units 15009-0540, 15006-9967
REASON: Blood products, collected from an ineligible donor
with a history of Crohn’s disease, were distributed.
MANUFACTURER: United Blood Services, Texas Blood
Institute - Lubbock Center, Lubbock, TX
RECALLED BY: Blood Systems, Incorporated, Scottsdale, AZ
DISTRIBUTION: TX
QUANTITY: 4 Units
PRODUCT AND CODE: Red Blood Cells Unit
22414-9241
REASON: Blood product, was distributed after the donor
reported having developed Herpes Simplex the night following the donation.
MANUFACTURER: United Blood Services, Las Vegas, NV
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: HIV p24 Antigen Test Kit,
Lots 7288M201, 75339M101
REASON: HIV p24 test kits exhibit an initial reactive
rate, which is higher than the initial reactive rate documented in the package
insert.
MANUFACTURER/RECALLING FIRM: Abbott Laboratories,Abbott
Park, IL
DISTRIBUTION: Nationwide
QUANTITY: 698 kits were distributed
PRODUCT AND CODE: Red Blood Cells, Units
R34824, R34827, R34829, R34831, R34832
REASON: Blood products, labeled with extended expiration
dates, were distributed.
MANUFACTURER/RECALLING FIRM: San Diego Blood Bank, San
Diego, CA
DISTRIBUTION: CA
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, Leukoreduced
(Pheresis), Split Units 15386-7710, 15386-7724, 15386-8007. (The 1st bag was distributed under product
code 04741 and the 2nd bag under product code 04761).
REASON: Blood products, which were stored at unacceptable
temperatures, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Midland, TX
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: Texas
QUANTITY: 6 unit
PRODUCT AND CODE: Platelets, Unit 7837039; Cryoprecipitate,
Unit 7517935; Fresh Frozen Plasma, Unit 7837039
REASON: Blood products, prepared from Whole Blood units
that had discrepant start and end times documented, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit KJ36832
REASON: Red Blood Cells, leukoreduced by filtration
greater than five days past the time of collection, was distributed.
MANUFACTURER:
Central Blood Bank, Pittsburgh, PA
RECALLED BY: Institute for Transfusion Medicine Clinical
Services, Pittsburgh, PA
DISTRIBUTION: PA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocyte
Reduced, Unit C30023
REASON: Blood product, which was stored at unacceptable
temperatures, 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
C42273, C42893
REASON: Blood products, which may have been stored at
unacceptable temperatures, were distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
DISTRIBUTION: IN
QUANTITY: 2 units
WEEK ENDING SEPTEMBER 8
PRODUCT AND CODE: Platelets, M30669, M31111,
M31418, S61759; Fresh Frozen Plasma, M30669, M131111, M31300
REASON: Blood products, collected from donors who had
taken a category X medication, were distributed.
MANUFACTURER: Michigan Community Blood
Centers, Grand Rapids, MI
DISTRIBUTION: MI
QUANTITY: 7 units
PRODUCT AND CODE: Amicus Separator Apheresis
Instrument with software version 2.50
REASON: Blood collection device may return an
inappropriate volume of plasma to a donor during an apheresis procedure.
MANUFACTURER: Baxter Healthcare
Corporation, Largo, FL
RECALLED BY: Baxter Healthcare Corp., Round Lake, FL
DISTRIBUTION: Nationwide and internationally
QUANTITY: 184 Units
PRODUCT AND CODE: Source Plasma Unit 4GG923A
REASON: Blood product, collected from a donor who had been
incarcerated, was distributed.
MANUFACTURER/RECALLING FIRM: Centeon Bio-Services,
Kansas City, MO
DISTRIBUTION: UK
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced , Unit 15-0102747.
REASON: Blood product, collected from a donor taking
Aricept (Donepezil Hydrochloride), was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Midland, TX.
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: TX.
QUANTITY: 1 unit.
PRODUCT AND CODE: Platelets, Pheresis,
Leukoreduced, Irradiated, Unit C10190
REASON: Blood product, for which documentation of
irradiation was incomplete, was distributed.
MANUFACTURER: Aurora Area Blood Bank,
Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells Units GJ64116,
GJ61664; Recovered Plasma Units
GJ64116, GJ61664
REASON: Blood products, which tested negative for the
antibody to the human immunodeficiency virus type 1/2, but were collected from
a donor who previously tested repeatedly reactive for the antibody, Western
Blot indeterminate for HIV-1, were distributed.
MANUFACTURER: Tri-Counties Blood Bank,
Santa Barbara, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced , Unit 12449-7666
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Albuquerque, NM
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: New Mexico
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells , Unit
#1856960; Recovered Plasma, Unit #1856960
REASON: Blood products, that tested negative for antibody
to hepatitis C virus (anti-HCV), but were collected from a donor that
previously tested repeatedly reactive to anti-HCV, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers,
Shreveport, LA
DISTRIBUTION: LA, CA
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, Unit #1767543
REASON: Blood product, that tested negative for antibody
to human immunodeficiency virus (anti-HIV), but was collected from a donor that
previously
tested repeatedly reactive to anti-HIV, was distributed.
MANUFACTURER: LifeShare Blood Centers,
Shreveport, LA
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: AlloDerm Acellular dermal
graft for human transplantation, Lot
B0856, Repliform Tissue Regeneration Matric, Lot B0856
REASON: Human tissue for transplant, collected from a donor
in which HIV-1 PCR testing detected HIV DNA, were distributed.
MANUFACTURER/RECALLING FIRM: LifeCell Corporation,
Branchburg, NJ
DISTRIBUTION: NY, CA, MA and NC
QUANTITY: 18 pieces
PRODUCT AND CODE: Red Blood Cells,
Irradiated, Unit 08V00125
REASON: Blood product, for which documentation of
irradiation was incomplete, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, San Jose, CA.
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis, Unit
08LG05773
REASON: Blood product, with elevated platelet count, was
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, San Jose, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, Unit #08LG05369
REASON: Platelets with a decreased platelet count were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, San Jose, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, Unit #08LG03414
REASON: Blood product, that was labeled leukoreduced but
was not tested to determine the white blood cell count as required
in
the firm's standard operating procedures, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, San Jose, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, Unit #G17870
REASON: Blood product, that was labeled leukoreduced but was
not tested to determine the white blood cell count as required in the firm's
standard operating procedures, was distributed.
MANUFACTURER/RECALLING FIRM: Northern Illinois Blood
Bank, Inc., Rockford, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
#07FK52916
REASON: Blood product, collected from an unsuitable donor
based on living in an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Tucson, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
#03FH08587
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, Atlanta, GA
DISTRIBUTION: Georgia
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood CellsUnit
49Y76410; Platelets, Unit 49Y76410
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Tulsa, OK
DISTRIBUTION: TX, OK
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Unit #10628-1398; Platelets, Irradiated, Unit #10628-1398
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Chandler, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
#10624-4780
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: Arizona,
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Unit #’s 10617-2151, 10623-5350, and 10629-2757
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
10621-4143; Platelets, 10621-4143
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells (2 units),
Unit 36259-2121 (two split units)
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Ventura, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
10625-7923
REASON: Blood product, collected from an unsuitable donor based
on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,Mesa,
AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,Unit
#0345010 and 0351621; Platelets, Unit #0345010
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Bank of
Erie County, Erie, PA
DISTRIBUTION: PA
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, Unit
#5291156
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
#084FT13479
REASON: Blood product, collected from a donor whose
hematocrit was not determined, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Oakland, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Mumps Skin Test Antigen
USP, 0.1 ml, Lot U0225AA
REASON: Results of routine stability testing conducted by
the manufacturer found that the potency of the lot had fallen below the product
specification prior to the product’s expiration date.
MANUFACTURER/RECALLING FIRM: Aventis Pasteur, Inc.,
Swiftwater, PA
DISTRIBUTION: Nationwide
QUANTITY: 16, 354 vials
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 04K36308
REASON: Blood product, collected from a donor with a
history of Idiopathic Thrombocytopenic Purpura, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Dedham, MA
DISTRIBUTION: NH
QUANTITY: 1 Unit
PRODUCT AND CODE: a) Platelets, Unit numbers:
50C01823, 50C01825, 50C01834, 50LG33157, 50C01809, 50LG33178, 50C01839,
50C01846, 50C01856, 50C01863, 50LG33160, and 50LG33180; b)Platelets
Irradiated, Unit numbers: 50LG33254, 50LJ23586, 50C01764, 50LG33120,
50LJ23494, 50LJ23505, and 50LJ23519
REASON: Platelets, not stored under continuous agitation,
were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Toledo, OH
DISTRIBUTION: OH
QUANTITY: a) Platelets (12 units); b) Platelets Irradiated
(7 units) 19 units
PRODUCT AND CODE: Red Blood Cells, Unit
912-5195
REASON: Blood product, collected under conditions where
the sterility may have been compromised, was distributed.
MANUFACTURER/RECALLING FIRM: United Blood
Services-Tucson, Tucson, AZ
RECALLED BY: Blood System, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Unit 004-1741
REASON: Blood product, collected under conditions where
the sterility may have been compromised, was distributed.
MANUFACTURER: United Blood Services, Tucson,
AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Units
GJ2711, GJ73965, GK15229,
REASON: Blood product, collected under conditions where
the sterility may have been compromised, was distributed.
MANUFACTURER/RECALLING FIRM: Tri-Counties Blood Bank,
Santa Barbara, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, Unit 24KC22384;
Recovered Plasma, Unit 24KC22384
REASON: Blood product, collected from a donor taking the
drug Amantadine, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Louisville, KY
DISTRIBUTION: KY
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Unit 22412-5755
REASON: Blood product that was out of controlled storage
for more than 30 minutes was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Las
Vegas, NV
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: NV
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Irradiated,
Unit 22418-6944
REASON: Blood product that was out of controlled storage
for more than 30 minutes was distributed.
MANUFACTURER: Blood Systems, Inc., Las
Vegas, NV
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: NV
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Irradiated, Units
13GC71452, 17KK77071, 17KK77074, 53GC28063, 53FN53992, 53GJ09954,
30GN19667, 30GN19643, 30GN19641, 30GN19666, and 53FQ72572
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 11 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Irradiated,
Unit 11FM55571
REASON: Blood product that was out of controlled storage
for more than 30 minutes was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Southern Region, Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Irradiated ,
Units 17FH92548, 17FZ29358, 17FH92549, 17FH92637, 17FH92611, and
17FH92641; Red Blood Cells, Irradiated, unit number 03H11727
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Southern Region, Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 7 units
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, Units 03F10299,
03F10300 (two split units), 03F10301, 03F10302 (two split units), 03F10303,
03F10304, and 03F10305
REASON: Blood products, exposed to unacceptable storage
temperatures, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Valdosta, GA
RECALLED BY: American National Red Cross, Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 9 units
PRODUCT AND CODE: Red Blood Cells, Units
2641716 and 1371607
REASON