OCTOBER 2001
WEEK ENDING OCTOBER 6
PRODUCT AND CODE: Platelet, Pheresis, (Split
unit) 16356-6320
REASON: Blood products, which had an unacceptable platelet
count, were distributed.
MANUFACTURER/RECALLING FIRM: United Blood Services,
Meridian, MS
RECALLED BY: Blood System, Inc., Scottsdale, AZ
DISTRIBUTION: MS
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 36LR17052
REASON: Blood product prepared from an overweight whole
blood unit was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, South
Carolina Region, Columbia, SC
DISTRIBUTION: SC
QUANTITY: 1 unit
PRODUCT AND CODE: Recovered Plasma, Unit
1693871
REASON: Blood product, collected from a donor taking the
drug Accutane, was distributed.
MANUFACTURER/RECALLING FIRM: South Texas Blood and
Tissue Center, San Antonio, Texas
DISTRIBUTION: CA and Scotland
QUANTITY: 1 unit
PRODUCT AND CODE: Saphenous Vein , Serial
numbers 3896463, 3896471
REASON: Tissues for transplant were collected from a donor
who had not been properly evaluated.
MANUFACTURER/RECALLING FIRM: CryoLife, Inc., Kennesaw,
GA
DISTRIBUTION: OH and LA
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma, unit
numbers 8S9361 and 8S9632
REASON: Blood products, collected from an ineligible donor
due to previous incarceration, were distributed.
MANUFACTURER/RECALLING FIRM: Aventis Bio-Services,
Inc., Fort Worth, TX
DISTRIBUTION: IL
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 7829805; Fresh Frozen Plasma, unit number 7829805
REASON: Blood products, that tested negative for human
immunodeficiency virus (HIV), but were collected from a donor who did not
answer a donor screening question related to behavior known to increase the
risk of infection with HIV, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX and FL
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 7586817; Fresh Frozen Plasma, unit number 7586817
REASON: Blood products, that tested negative for human
immunodeficiency virus (HIV), but were collected from a donor who did not
answer a donor screening question related to behavior known to increase the
risk of infection with HIV, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 7472341
REASON: Blood products, that tested negative for human
immunodeficiency virus (HIV), but were collected from a donor who did not
answer a donor screening question related to behavior known to increase the
risk of infection with HIV, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare,
Bedford, TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells (11
units), unit numbers 55S80206, 55C29112, 55C26581, 55C03644, 55R83694,
55C79450, 55C00186, 55C96961, 55C64579, 55L80073, and 55L67747
Red
Blood Cells, Leukocytes Reduced (8 units), unit numbers 55FR17412, 55K22123,
55FR13870, 55FR11291, 55FR10554, 55L27539,
55FR07873,
and 55C14569
Platelets
(5 units), unit numbers 55C03644, 55C29112, 55C26581, 55C64579, and 55L80073
Fresh
Frozen Plasma (10 units), unit numbers 55FR17412, 55K22123, 55FR11291,
55C03644, 55L27539, 55FR07873, 55C29112, 55C26581,
55C14569,
and 55C79450
Recovered
Plasma (8 units), unit numbers 55FR13870, 55FR10554, 55S80206, 55R83694,
55C96961, 55C64579, 55C93992, and 55L80073
REASON: Blood products that tested negative for the
antibody to human immunodeficiency virus (anti-HIV), but were collected from a
donor that previously tested repeatedly reactive for anti-HIV, were
distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Little Rock, AR
DISTRIBUTION: AR, MO, TN, CA and Switzerland
QUANTITY: 42 units
PRODUCT AND CODE: Red Blood Cells, Unit 7559586;
Fresh Frozen Plasma, Unit 7559586
REASON: Blood products, collected from a donor whose body
temperature had not been documented, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: TX
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, Leukoreduced,
Irradiated, Units, P10567, P10568.
REASON: Blood products, which were leukoreduced using
expired filters, were distributed.
MANUFACTURER/RECALLING FIRM: Coffee Memorial Blood
Center, Inc., Amarillo, Texas
DISTRIBUTION: TX
QUANTITY: 2 units
PRODUCT AND CODE: Mixed Ragweed Injectable
Allergenic Extract, lot numbers 1B01031, 1B00811, and 1B00791
REASON: Allergenic extracts were distributed labeled with
incorrect expiration dates.
MANUFACTURER/RECALLING FIRM: Center Laboratories, Inc.,
Port Washington, NY
DISTRIBUTION: MI, NY, IL, KA, CT, KY, MA, OH, PA, TX
QUANTITY: 3 lots
PRODUCT AND CODE: Red Blood Cells, Pheresis,
Leukocytes Reduced (4 units), unit numbers 18224-2359 and 18225-0038 (both
units distributed as two split units)
REASON: Blood products, collected on an apheresis machine
where there was no documentation of evaluation of the filter assemblies as
required, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Cheyenne, WY
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: WY and TX
QUANTITY: 4 units
PRODUCT AND CODE: Reagent Red Blood Cells,
Gamma Panel 15?, lot number 0410267; Reagent Red Blood Cells, Gamma Panel 15?
(0.8%), lot number 0410268
REASON: Reagent Red Blood Cells were distributed with
incorrect documentation of antigen types.
MANUFACTURER/RECALLING FIRM: Gamma Biologicals, Inc.,
Houston, TX
DISTRIBUTION: Nationwide and internationally
QUANTITY: 2 lots
PRODUCT AND CODE: Recovered Plasma, unit
number 7472341
REASON: Blood products, that tested negative for human
immunodeficiency virus (HIV), but were collected from a donor who did not
answer a donor screening question related to behavior known to increase the
risk of infection with HIV, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: Switzerland
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma (32 units),
unit numbers 3Z0345, 3Z8806, 7RM589, 7RN050, 7RN278, 7RN805, 7RV468, 7RV956,
8BN149, 8BO024, 8BS660, 8BT373, 8BT546, 3Z7856, 3Z0019, 3Y1058, 3Y1253, 3Y1348,
3Y2454, 3Y2617, 3Y2848, 3Y3061, 3Y3275, 3Y3457, 3Y3639, 64G140, 64G252, 7RJ535,
7RJ830, 7RK062, 7RK875, and 7RL133
REASON: Blood products that tested negative for viral
markers, but were collected from donors who were improperly screened prior to
donation, were distributed.
MANUFACTURER/RECALLING FIRM: Aventis Bio-Services,
Inc.,Lexington, KY
RECALLED BY: Aventis Central Testing Laboratory,
Knoxville, TN
DISTRIBUTION: NC
QUANTITY: 32 units
PRODUCT AND CODE: Red Blood Cells, Unit
7444384; Platelets, Unit 7444384; Recovered Plasma, Unit 7444384
REASON: Blood products, which were collected from a donor
with an elevated body temperature, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: TX and Switzerland
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 7472214; Platelets, Pheresis, Leukoreduced, Unit 7587173;
Recovered Plasma, Units 7586983, 7472214
REASON: Blood products, collected from a donor whose arm
inspection was not documented, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: TX and Switzerland
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, Unit
V00958
REASON: Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Topeka, KS
DISTRIBUTION: KA
QUANTITY: 1 unit
WEEK ENDING OCTOBER 13
PRODUCT AND CODE: Red Blood Cells, unit
number 20H26216; Platelets, unit number 20H26216; Fresh Frozen Plasma, unit
number 20H26216
REASON: Blood products, collected from a donor that
subsequently provided a history of a positive test for hepatitis, were distributed.
MANUFACTURER: The American National Red Cross, Salt Lake
City, UT
RECALLED BY: American Red Cross Blood Services, Boise,
ID
DISTRIBUTION: California and Utah
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
number 20M06695; Recovered Plasma, unit number 20M06695
REASON: Blood products, collected from a donor that
subsequently provided a history of positive tests for hepatitis B, were
distributed
MANUFACTURER: The American National Red Cross, Salt Lake
City, UT
RECALLED BY: American Red Cross Blood Services, Boise,
ID
DISTRIBUTION: California
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 20M06828; Recovered Plasma, unit number 20M06828
REASON: Blood products, collected from a donor that
subsequently provided a history of a positive test for hepatitis, were
distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Salt Lake City, UT
RECALLED BY: American Red Cross Blood Services, Boise,
ID
DISTRIBUTION: California
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 040LR05579; Recovered Plasma, unit number 040LR05579
REASON: Blood products that tested negative for the
antibodies to the human immunodeficiency virus (anti-HIV), but were collected
from a donor that previously tested repeatedly reactive for anti-HIV, were
distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Peoria, IL
DISTRIBUTION: NE and CA
QUANTITY: 2 units
PRODUCT
AND CODE: Source Plasma, unit number 38647758
REASON: Blood product that was collected from a donor that
previously tested repeatedly reactive for the antibody to hepatitis C virus
(anti-HCV), were distributed.
MANUFACTURER/RECALLING FIRM: Nabi, Corpus Christi, TX,
DISTRIBUTION: California
QUANTITY: 1 unit
PRODUCT AND CODE: Platelet, Pheresis,
Leukoreudced, Unit 16354-1741(split units)
REASON: Blood products, which were labeled as
leukoreduced, but that failed the quality control specification for white blood
cell count, were distributed.
MANUFACTURER: United Blood Services, Meridian, MS
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: Mississippi and Texas
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma (26 units),
unit numbers 0051876, 0053560, 0055603, 0057150, 0060264, 0065912, 0051240,
0054176, 0055878, 0057556, 0061959, 0052577, 0054471, 0056282, 0057707,
0062682, 0052752, 0054807, 0056519, 0058447, 0062719, 0053278, 0055185,
0056914, 0058675, and 0065381
REASON: Blood products, that tested negative for viral
markers, but were collected from a donor that subsequently providing
disqualifying
information
concerning a history of: 1) incarceration; and 2) tattoos, were distributed.
MANUFACTURER/RECALLING FIRM: Westgate Biologicals,
Inc., College Station, TX
RECALLED BY: Diagnostic Chemistries, Inc., Mount Kisco,
NY
DISTRIBUTION: New York
QUANTITY: 26 units
PRODUCT AND CODE: Red Blood Cells, Unit
5361624; Cryoprecipitate Unit 5361624; Recovered Plasma, Unit 5361624
REASON: Blood product, collected from a donor with a
history of having tested positive for hepatitis, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: Texas and Switzerland
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells Unit 4878852; Recovered Plasma Unit 4878852
REASON: Blood products, collected from a donor with a
history of having tested positive for anti-HCV, with a negative RIBA, were
distributed.
MANUFACTURER/RECALLING FIRM: Our Lady of the Lake
Hospital, Inc., Baton Rouge, LA
DISTRIBUTION: LA and FL
QUANTITY: 2 units
PRODUCT AND CODE: Fresh Frozen Plasma, Unit
10709-7376; Platelets, Unit 10709-7376
REASON: Blood products, corresponding to a unit of clotted
Red Blood Cells, were distributed.
MANUFACTURER: United Blood Services, Scottsdale, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
5327406
REASON: Blood product, collected from a donor who was
participating in an experimental drug study, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 20LM75309; Recovered Plasma, unit number 20LM75309
REASON: Blood products,which tested negative for anti-HCV,
but were collected from a donor who had previously tested reactive for
anti-HCV, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, Boise,
ID
DISTRIBUTION: ID
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, Pheresis,
Leukoreduced, Irradiated, Unit 40FP12993
REASON: Blood product, labeled as irradiated but did not
meet the requirements for irradiation, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Peoria, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma for
Manufacturing Use Only, Unit 00MMNB8076
REASON: Blood product, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, was distributed
MANUFACTURER: Community Bio-Resources, Inc., Mankato, MN
RECALLED BY: Community Bio-Resources, Inc., Hoover, AL
DISTRIBUTION: Austria
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Units
2166658, 1281004; Red Blood Cells, Leukoreduced, Unit 4118199; Platelets, Unit
2166658; Fresh Frozen Plasma, Units 2166658, 4118199
REASON: Blood products, collected from a donor who had
received a dura mater graft, thirty years prior to donation, were distributed
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Kansas City, MO
DISTRIBUTION: Missouri, Kansas and Ohio
QUANTITY: 6 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 10631-4160
REASON: Blood product that was not quarantined after
receiving information concerning a post donation illness, was distributed.
MANUFACTURER/Manufacturer: United Blood Services,
Scottsdale, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Fresh Frozen Plasma, Unit
10708-6547
REASON: Blood product, corresponding to a unit of clotted
Red Blood Cells, was distributed.
MANUFACTURER: United Blood Services, Scottsdale, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Fresh Frozen Plasma, Unit
10704-7955
REASON: Blood product, corresponding to a unit that was
observed to have clots, was distributed.
MANUFACTURER: United Blood Services, Scottsdale, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, Units
8MW086B, 9J9631B, 9J9719B, 9NS107B, 9NS829B, 9SW795B, 814206B, 814307B
REASON: Blood products, collected from a donor who had a
history of drug use, were distributed.
MANUFACTURER/RECALLING FIRM: Aventis Bio-Services,
Inc., Oklahoma City, OK
DISTRIBUTION: IL
QUANTITY: 8 units
PRODUCT AND CODE: Corneas, Units
MSN-2000-0507, MSN-2000-0508
REASON: Corneas, collected from a donor who tested
repeatedly reactive for the HTLV I/II antibody, with an indeterminate HTLV
Western Blot, were distributed.
MANUFACTURER/RECALLING FIRM: Lions Eye Bank of
Wisconsin, Inc., Madison, WI
DISTRIBUTION: WI
QUANTITY: 2 units
WEEK ENDING OCTOBER 20
PRODUCT AND CODE: Platelets Unit 7751352
REASON: Unit of red blood cells, implicated in a
transfusion reaction, was found contaminated with Staphylococcus aureus. Corresponding blood products were
distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit number
99GMIE6807
REASON: Source Plasma, which was collected from a donor
who was accepted for donation within four weeks of receipt of an MMR
immunization, was distributed.
MANUFACTURER/RECALLING FIRM: Community Bio-Resources,
Inc., Grand Rapids, MI
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Whole Blood ,unit M53886;
Platelets, Pheresis ,units K14465 and K13687; Platelets ,units T57068, T55284,
and T045922; Fresh Frozen Plasma units, T75696, T65873, T57068, T045922, and
T030337
REASON: Blood products, which contained anti-Fya and
anti-Bg but were labeled as negative for unexpected antibodies, were
distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Topeka, KS
DISTRIBUTION: KA, MI, FL, NY, IN, KY, AL, GA
QUANTITY: 10 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Irradiated, Unit 10708-1375
REASON: Blood product, for which documentation of
irradiation was incomplete, was distributed.
MANUFACTURER: United Blood Services, Scottsdale, AZ
DISTRIBUTION: Arizona
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Units 33GS09579, 33GS09580, 33LL89335
REASON: A unit of Pooled Platelets, Leukoreduced,
implicated in a transfusion reaction, was found contaminated with Staphloccus
aureus. Corresponding blood products were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Connecticut Region, Farmington, CT
DISTRIBUTION: CT
QUANTITY: 3 units
PRODUCT AND CODE: Corneas, Units MSN-2000-0965, MSN-2000-0966
REASON: Corneas, collected from a donor who tested
repeatedly reactive for the HTLV I/II antibody, with a negative HTLV Western
Blot, were distributed.
MANUFACTURER/RECALLING FIRM: Lions Eye Bank of
Wisconsin, Inc., Madison, WI
DISTRIBUTION: WI
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
55C29521; Platelets, Unit 55C29521; Fresh Frozen Plasma, Unit 55C29521
REASON: Blood products collected from a donor with a history
of having tested positive for HCV was distributed.
MANUFACTURER/RECALLING FIRM: American National Red
Cross, Little Rock, AR
DISTRIBUTION: AZ
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma, Units
FN0004446, FN0004481, FG0032236, FG0032392, FG0032913
REASON: Blood products, collected from a donor who had
been permanently deferred at another donor center for having had a reactive
viral marker test, were distributed.
MANUFACTURER/RECALLING FIRM: Sera-Care Fort Smith/BHM
Labs, Fort Smith, AR
DISTRIBUTION: Spain
QUANTITY: 5 units
PRODUCT AND CODE: Source Plasma, Units
4WG262A, 4WG558A, 4WF974A
REASON: Blood Products, collected from a donor who had
engaged in high risk behaviors, were distributed.
MANUFACTURER/RECALLING FIRM: Centeon (Aventis) Bio-Services,
Inc., Tulsa, OK
DISTRIBUTION: IL and TN
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, Unit 5331819
REASON: Blood product, collected from a donor with a
history of jaundice, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Tx.
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
LR44461; Recovered Plasma, Unit LR44461
REASON: Blood products, collected from a donor with a
history of Hepatitis A, were distributed.
MANUFACTURER/RECALLING FIRM: The Blood Center of
Central Iowa, Des Moines IA
DISTRIBUTION: IL and Switzerland
QUANTITY: 2 units
PRODUCT AND CODE: Platelet, Pheresis,
Leukoreduced (Split #3), Unit 107-7-2502
REASON: Blood product, which had a high platelet count,
was distributed.
MANUFACTURER: United Blood Services, Scottsdale, AZ
RECALLED BY: Blood Systems Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Platelet, Pheresis,
Leukoreduced (Split units)
Units
15386-9795
15386-9890
15386-9896
15387-0353
15387-0363
15387-0382
15387-0425
15387-0490
15387-2325
15387-2333
15387-2439
15387-2443
15387-2456
REASON: Blood products, which had a high platelet count,
were distributed
MANUFACTURER/RECALLING FIRM: United Blood Systems, Inc.,
Lubbock, Texas
DISTRIBUTION: TX
QUANTITY: 26 units
PRODUCT AND CODE: Red Blood Cells, Unit
number L27547
REASON: Blood product,that tested positive for the c
antigen, but was labeled c antigen negative, was distributed.
MANUFACTURER/RECALLING FIRM: Central Illinois Community
Blood Bank, Springfield, IL 62703
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 42FS65173; Recovered Plasma, unit number 42FS65173
REASON: Blood products, that tested negative for
antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but
were collected from a donor that reported previously tested reactive for
anti-HIV, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Cleveland, OH
DISTRIBUTION: OH and CA
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, unit number
7260139; Recovered Plasma, unit number 7260139
REASON: Blood products, that tested negative for the
antibody to human immunodeficiency virus, type 1 (anti-HIV-1), but were
collected from a donor that previously tested repeatedly reactive for
anti-HIV-1, were distributed.
MANUFACTURER/RECALLING FIRM: New York Blood Center,
Inc., New York, NY
DISTRIBUTION: NY
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells (11 units),
unit numbers 2391722, 2349976, 2288525, 2271728, 2963378, 2878216, 2790053,
2593211, 2489919, 2461890, and 2383187
Platelets
(5 units), unit numbers 2391722, 2349976, 2288525, 2271728, and 2461890
Cryoprecipitated
AHF (2 units), unit numbers 2878216 and 2790053
Fresh
Frozen Plasma (1 unit), unit number 2271728
Source
Leukocytes (1 unit), unit number 2391722
Recovered
Plasma (10 units), unit numbers 2391722, 2349976, 2288525, 2963378, 2593211,
2489919, 2461890, 2383187, 2878216, and 2790053
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 donors that previously tested repeatedly reactive for
anti-HIV-1/2, were distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: TX, CA, Fl, and NJ
QUANTITY: 30 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 36FF06361
REASON: Blood product collected in a manner that may have
compromised sterility was distributed.
MANUFACTURER: The American National Red Cross,
Charleston, SC
RECALLED BY: The American National Red Cross, Columbia,
SC
DISTRIBUTION: SC
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Units
26164-0085, 26164-0086
REASON: Blood products, collected from donors who reported
travel to an area designated as endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Fort
Smith, AR
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AR
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 15012-8539
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER: United Blood Services, Lubbock, TX
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
352-9407; Recovered Plasma, Unit 352-9407
REASON: Blood products, collected from a donor who was
exposed to a needle stick while in a Group O HIV risk area, were
distributed.
MANUFACTURER/RECALLING FIRM: United Blood Services,
Meridian, MS
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: MS
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Leukoreduced,
Unit 49GR50852
REASON: Blood product, collected from a donor taking the
drug Methotrexate, was distributed.
MANUFACTURER/RECALLING FIRM: American National Red
Cross, Tulsa, OK
DISTRIBUTION: OK
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, Units
0200233074, 0200232869, 0200232623, 0200232198, 0200231997, 0200231741,
0200231589, 0200232458, 0200231341, 0200231159, 0200230484, 0200230300,
0200230026, 0200229859, 0200229550, 0200229375, 0200223481, 0200245976,
0200245675, 0200245326, 0200245132, 0200244925, 0200244180, 0200243993,
0200243512, 0200243053, 0200242740, 0200242540, 0200242179, 0200241021,
0200235293, 0200234180, 0200233965, 0200233466
REASON: Blood products, collected from a donor who had a
tattoo within twelve months of donation, were distributed.
MANUFACTURER/RECALLING FIRM: Nabi, Norman, Ok
DISTRIBUTION: NY and Korea, United Kingdom
QUANTITY: 34 units
PRODUCT AND CODE: Red Blood Cells (Split
unit), Unit 7586815
REASON: Blood product, collected from a donor with a
history of jaundice, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: TX
QUANTITY 2 units
PRODUCT AND CODE: Units 947214, 947361,
947551, 949508, 949894, 95A180, 95N605, 95N968, 9VY339, 9VY495
REASON: Blood products, collected from a donor who engaged
in high-risk behavior, were distributed.
MANUFACTURER/RECALLING FIRM: Aventis Bio-Services,
Inc., Oklahoma City, OK
DISTRIBUTION: IL
QUANTITY: 10 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Unit number C46657
REASON: Blood product that was out of controlled storage
for more than 30 minutes was distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced, unit number H97216
REASON: Blood product, untested for the antibody to
hepatitis C virus (anti-HCV), was distributed.
MANUFACTURER/RECALLING FIRM: Regional Health Resource
Center, Urbana, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Irradiated, Unit 42FH05199
REASON: Blood product, labeled with an extended expiration
date, was distributed.
MANUFACTURER/RECALLING FIRM: St. Elizabeth Health
Center, Youngstown, OH
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Recovered Plasma, unit
7751352
REASON: Unit of recovered plasma, implicated in a
transfusion reaction.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
Texas
DISTRIBUTION: Switzerland
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit number
99GMIE8596
REASON: Source Plasma, which was collected from a donor
who was accepted for donation within four weeks of receipt of an MMR
immunization, were distributed.
MANUFACTURER/RECALLING FIRM: Community Bio-Resources,
Inc., Grand Rapids, MI
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, units
K10480, S00147, K01880, T94445, T92792, T79231, T75696, T67833, T65873, T62360,
T58570, T57068, T55284, T047839, T045922, T039722, T002195, and T030337
Red
Blood Cells, Leukoreduced, unit T99018
REASON: Blood products, which contained anti-Fya and
anti-Bg but were labeled as negative for unexpected antibodies, were
distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Topeka, KS
DISTRIBUTION: KS, MO, FL, NY, IN, KY, AL, GA
QUANTITY: 19 units
PRODUCT AND CODE: Whole Blood for further
manufacture, unit number VF-07553
REASON: Blood product, that tested negative for viral
markers, but was collected from a donor whose health history was inadequately
determined, was distributed.
MANUFACTURER/RECALLING FIRM: Pyramid Biological
Corporation, Van Nuys, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Fresh Frozen Plasma, Unit
084FT15792
REASON: Blood product, prepared from a unit of Whole Blood
that should have been designated as a slow bleed, was distributed.
MANUFACTURER/RECALLING FIRM: The American Red Cross,
San Jose, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Unit 5300696
REASON: Blood product, prepared from a Whole Blood unit
that had discrepant start and end times documented, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 17195-9179
REASON: Red Blood Cells, that failed the red cell recovery
ratio, were distributed.
MANUFACTURER: Blood Systems, Inc., McAllen, TX
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Unit 10625-8071; Recovered Plasma, Unit 10625-8071
REASON: Blood products, collected from a donor who
received a tissue transplant within a year of donation, were distributed
MANUFACTURER/RECALLING FIRM: United Blood Services,
Scottsdale, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ and VA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
08FR19156
REASON: Blood product, collected from donor who exceeded
the donor acceptance criteria for body temperature, was distributed.
MANUFACTURER/RECALLING FIRM: American National Red
Cross, San Jose, CA
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Pheresis,
Units 10004-0270 (bag 1 and 2); Platelets, Pheresis, Unit 10619-9328
REASON: Blood products, collected in a manner that cannot
assure that the units are sterile, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc,
Tucson, AZ
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, Unit
M66735
REASON: Blood product, which was not refrigerated within 8
hours of Whole Blood collection, was distributed.
MANUFACTURER/RECALLING FIRM: Lane Memorial Blood Bank,
Eugene, OR.
DISTRIBUTION: OR
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis, Unit
6756762
REASON: Blood product, collected from a donor taking
Ancef, was distributed.