APRIL 2006
WEEK ENDING APRIL 1
PRODUCT
Achilles Tendon with
Bone, Frozen, Irradiated
CODE Tissue
040484-018
RECALLING FIRM/MANUFACTURER Community Blood Center, dba
Community Tissue Services, Portland, OR
REASON Human tissue, positive for Propionibacterium acnes
on final culture after processing, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 tissue
DISTRIBUTION Korea
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
20FZ22044
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American National Red Cross, Lewis and Clark Region, Boise, ID
Manufacturer: American National Red Cross, Missoula,
MT.
REASON Blood product,
collected from a donor for whom donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MT
PRODUCT
a) Red Blood Cells
b) Cryoprecipitated
AHF, Pooled,
c) Recovered Plasma
CODE a), b), and c)
Unit number: 0633536
RECALLING FIRM/MANUFACTURER Hoxworth Blood
Center, Cincinnati, OH
REASON Blood products, collected from an ineligible
donor due to a history of intravenous drug use, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IN and OH
PRODUCT
a) Red Blood Cells
b)
Platelets
c) Cryoprecipitated AHF
CODE a), b), and c) Unit number:
12H21309
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood products, which 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 3
units
DISTRIBUTION MD, NC, and PR
PRODUCT Red Blood Cells
CODE
Unit number: 040GN08023
RECALLING
FIRM/MANUFACTURER American National Red Cross, Heart of America, Peoria, 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 Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
9050706
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc.,
Greenville, SC,
REASON Platelets, with a platelet count above the firm’s
specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number: 36M71122
RECALLING FIRM/MANUFACTURER American National Red Cross, South
Carolina Region, Columbia, SC
REASON Blood product, manufactured from an
overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
003LY14844
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Platelets Pheresis, with an elevated
platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis
CODE
Unit number: 03KN18640
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Platelets, inappropriately prepared by splitting
the product into two storage bags instead of one, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number: 12W96818
(Part 1)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood product, collected in an
apheresis collection kit that exceeded the acceptable time period for use, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Irradiated
CODE Unit number:
9306695
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, for which documentation of irradiation was
incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
Irradiated
c) Cryoprecipitated AHF
d) Fresh
Frozen Plasma
e) Plasma, Frozen
f)
Recovered Plasma
CODE
a) Unit numbers:
03GS32813, 03GH28032;
b) Unit number: 03LM79071;
c) Unit number:
03GH28032;
d) Unit number: 03GS32813;
e) Unit number: 03GH28032;
f)
Unit number: 03LM79071
RECALLING FIRM/MANUFACTURER American
National Red Cross, Southern Region, Atlanta, GA,
REASON Blood products,
which 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 7
units
DISTRIBUTION CA, GA, and Switzerland
PRODUCT Platelets, Leukocytes
Reduced
CODE Unit number:
49GW24633
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southwest Region, Tulsa, OK.
REASON Blood product, associated with
a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells,
Washed
b) Recovered Plasma
CODE a) and b) Unit number: KC69321
RECALLING
FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem, Pa
REASON Blood products, collected from a donor who was
previously deferred for a history of intravenous (IV) drug use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ and PA
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit number:
6879943
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center,
Inc., Amarillo, TX
REASON Blood product, which was incorrectly labeled as
having been irradiated, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma
CODE
a) Unit numbers: 1411853, 1410232;
b) Unit number:
1410232
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center,
Inc., Amarillo, TX
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor with a history of Hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NJ, TN, and TX
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced,
c) Recovered Plasma
CODE
a) Unit numbers: 49LF64408, 49LF65369;
b) Unit numbers:
49LP11951, 49LP12030, 49LP12791;
c) Unit numbers: 49LF64408,
49LF65369
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southwest Region, Tulsa, OK
REASON Blood products, collected from a donor
who provided post donation information regarding multiple high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA, OK, TX, and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced, Irradiated
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated
CODE
a) Unit number: 6906034;
b) Unit number:
1410768
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center,
Inc., Amarillo, TX
REASON Blood products, for which documentation of
irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TX
PRODUCT Red Blood Cells,
CODE
Unit numbers: 3026275, 5502066
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL
Manufacturing
Firm: LifeSource Hyde Park Donor
Center, Chicago, IL,
REASON Blood products, collected from an ineligible donor
due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2 units
DISTRIBUTION IL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
027LW50207
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Alleghenies Region, Johnstown, PA
REASON Blood product, collected from a donor that did not answer
one of the medical history questions, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Platelet Pheresis,
Leukocytes Reduced
CODE Unit number:
6697433
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood
Bank, Sarasota, FL
REASON Blood product, possibly contaminated with several
skin contaminants, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
04710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Albuquerque, NM
REASON Blood product, collected from a donor
who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NM
PRODUCT Plasma
CODE Unit number: 4705440
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, collected from a donor whose medical history
screening was incomplete, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Platelets
CODE
Unit number: GP80277
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product,
inadvertently contaminated with Optisol (AS-5), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: G47666,
G47671, J06012, J06070, L53552, L53567, S37262, S37337, S37397
RECALLING
FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL
REASON
Blood products, mislabeled as leukocytes reduced,
were distributed
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: J02977, J03004, J02984,
J02991;
b) Unit number: J02997
RECALLING
FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL
REASON Blood products, collected on a trip scale that was
incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5 units
DISTRIBUTION IL
PRODUCT Fresh Frozen Plasma
CODE
Unit numbers: L53131, L53142,
S35408
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood
Center, Springfield, IL.
REASON Blood products, which lacked assurance
of proper shipping temperatures due to inaccurate documentation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 36LP23987
RECALLING
FIRM/MANUFACTURER American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood products,
collected from an ineligible donor due to receipt of the hepatitis B
vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and SC
PRODUCT Red Blood Cells
CODE
Unit number: 6443076
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product,
manufactured without the entire quantity of additive solution added, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
LH33536
RECALLING FIRM/MANUFACTURER Healthcare Provider Services,
Inc., Dba Rhode Island Blood Center, Providence, RI
REASON Blood product,
manufactured without the entire quantity of additive solution added, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red Blood Cells
CODE
Unit number: FH24943
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
Manufacturing Firm: Heartland Blood Centers Dekalb, Dekalb, IL.
REASON
Blood product, collected from
an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Platelets Pheresis Leukocytes
Reduced Irradiated
CODE a) and b) Unit
number: 38FX01910
RECALLING FIRM/MANUFACTURER The American National
Red Cross, Indiana-Ohio Region, Fort Wayne, IN
REASON Blood products, possible contaminated with coagulase-negative staphylococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MI
PRODUCT Platelets, Leukocytes
Reduced
CODE Unit number: H18610, H18611,
H18617, H18619, C67297
RECALLING FIRM/MANUFACTURER South Bend
Medical Foundation, South Bend, IN
REASON Blood products, which were
incorrectly tested for the antibody to the human T-lymphotropic virus (anti-HTLV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5
units
DISTRIBUTION IN
PRODUCT Source Plasma
CODE
Unit number: SH047021
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg, PA
REASON
Blood
product, collected from a donor whose donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION France
WEEK ENDING APRIL 8
PRODUCT Human Corneas for
Transplantation Tissues
CODE Tissues:
05-0191-100 and 05-0191-200
RECALLING FIRM/MANUFACTURER Mid South
Eye Bank for Sight Restoration, Inc., Memphis, TN.
REASON Human tissues for
transplantation, recovered from a donor who was subsequently found to have
tested positive for the hepatitis C virus by both NAT and antibody testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
tissues
DISTRIBUTION NY
PRODUCT Source Plasma
CODE
Unit numbers: N-37471-097, N-37494-097, G-91707-097,
G-91940-097, G-92659-097, G-92907-097, G-93645-097, G-93924-097,
G-95831-097, G-96149-097, G-97647-097, G-98705-097, G-99010-097,
G-05826-097, G-06673-097, G-07071-097, G-08072-097, G-08749-097,
G-09126-097, G-09719-097, G-10033-097, G-10970-097, G-11232-097, G-12389-097, G-12716-097, G-13674-097, F-00078-097, F-00367-097,
F-01024-097, F-01399-097, F-02473-097
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corp., San Diego, CA
REASON Blood
products, collected from a donor who had engaged in multiple high risk
behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31
units
DISTRIBUTION CA and Spain
PRODUCT Source Plasma
CODE
Unit numbers: SP-20158, SP-20620, SP-20633,
SP-20714, F-00335-044, F-00455-044, F-00483-044, F-00670-044, F-00706-044,
F-00828-044, F-00872-044, F-01171-044, F-01273-044, F-01315-044
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON
Blood products, which tested negative for
hepatitis, but were collected from an ineligible donor due to a history of
hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION CA and Austria
PRODUCT Source Plasma
CODE
Unit numbers: G-05988-072, F-00081-072, F-01523-072,
F-02979-072, F-19651-072, F-21287-072, F-22556-072, F-23698-072
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corporation, Long Beach, CA
REASON Blood products, collected from a donor who had a tattoo
applied within twelve months of donating, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8 units
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
06LR01358
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood product, which tested negative for the antibody to
the human T-lymphotropic virus type 1 (anti-HTLV-1), but was collected from a
donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot
positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Units (2 units)
004KC33387 -- parts 1 and 2
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, New England Region, Dedham, MA
REASON Platelets, possibly contaminated with
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VT and MA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
113431788
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX
REASON
Blood product, which tested initially non-reactive
for West Nile Virus (WNV) when tested in a pool of 16 donations, but was not
tested individually for WNV, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Human Corneas for
Transplantation
CODE Tissues 0078-06-01,
0078-06-02
RECALLING FIRM/MANUFACTURER North Carolina Eye Bank, Dorham,
NC
REASON Human tissues for transplantation, that tested
negative for hepatitis prior to distribution, but were subsequently found to
test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
tissues
DISTRIBUTION NC and TX
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number: 55P46462
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater
Ozarks-Arkansas Region, Little Rock, AR,
REASON Platelets, which were
possibly contaminated with Staphylococcus epidermidis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AR
PRODUCT Cryoprecipitated AHF
CODE
Unit number: 5650054
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product,
corresponding to a unit of red cells that was possibly contaminated with
coagulase-negative Staphylococcus and implicated in an adverse transfusion
reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Fresh Frozen Plasma
CODE
Unit number: 22GL27322
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA.
REASON Blood product,
in which the corresponding Platelets were possibly contaminated with coagulase-negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Human Saphenous Vein
CODE
Tissue number: 8306257
RECALLING
FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Human tissue
for transplantation, that tested negative for hepatitis prior to distribution,
but was subsequently found to test repeatedly reactive for antibodies to
hepatitis B core antigen (anti-HBc) by a different facility, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION MA
PRODUCT Cryoprecipitated AHF
CODE
Unit number: 16GW44163
RECALLING
FIRM/MANUFACTURER American National Red Cross, Central Ohio Region,
Columbus, OH
REASON Blood product,
corresponding to a unit of red cells that was implicated in a transfusion
reaction and was possibly contaminated with Aeromonas hydrophilia, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Human Cornea Tissue for
Transplantation
CODE Tissue number: 05-1136
OD
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA
REASON
Human Cornea, placed in an expired viewing
chamber, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION Japan
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers:
40P06964-P1, 40P06964-P2
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Heart of America Region, Peoria, IL.
REASON Blood products, collected in an
apheresis collection kit after the acceptable time period for use was exceeded,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Platelets Pheresis,
CODE
Unit number: 03F16197
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood product, collected from a donor
that did not answer one of the medical history questions, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells
b) Platelets,
c)
Fresh Frozen Plasma,
d) Recovered Plasma,
CODE
a) Unit numbers: 12V06564, 12P80910, 12C81080, 12X37662,
12X35755;
b) Unit number: 12X37662;
c) Unit number: 12X37662;
d) Unit
numbers: 12C81080, 12P80910, 12V06564, 12X35755
RECALLING
FIRM/MANUFACTURER American National Red Cross, Asheville, NC.
REASON
Blood products, that tested negative
for hepatitis, but were collected from an ineligible donor due to a subsequent
disclosure of previously positive hepatitis testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION NC and CA
PRODUCT Baxter ALYX Red Kit, For
Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation, For
Use with the ALYX Instrument; sterile single use unit consisting of a separation
chamber, an umbilicus, a cassette, 1 container 0.9% sodium chloride, 1 container
ACD-A anticoagulant, 1 container Adsol Red Cell Preservative Solution, 3 blood
component containers, 2 red cell storage containers, 1 18 gauge needle and 1
Sepacell leukoreduction filter
CODE All lot
numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G
and H05H, except those lots suffixed with "A" (H05I02028A, H05I13041A and
H05I19071A)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter Healthcare Corporation, Round Lake, IL
Manufacturer:
Baxter Healthcare Corporation, Mountain Home, AR
REASON Apheresis kits, manufactured with potential for
leaks from the cassette of the disposable kit, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 122,676 kits representing 67
lots
DISTRIBUTION Nationwide and Internationally
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
06LE31558
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood product, collected from a donor in which donor
suitability was not adequately determined, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced
CODE Unit numbers:
12645-8676 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Albuquerque, NM,
REASON
Blood products, collected from
a donor who did not have a complete medical history interview, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NM
PRODUCT Red Blood Cells
CODE
Unit number: 6029974
RECALLING
FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood
product, which tested negative for hepatitis, but was collected from an
ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 2120513,
2116438
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY,
REASON Blood products, associated with units of
Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY
PRODUCT Platelets
CODE
Unit number: 2166218
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Red Blood Cells
CODE
Unit number: 36FQ28150
RECALLING
FIRM/MANUFACTURER American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood product, which was not quarantined
after receiving information regarding a post-donation illness, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
06GC13649
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood product, which was
incorrectly labeled as being negative for unexpected antibodies, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 004GR31489
(Parts 1 & 2)
RECALLING FIRM/MANUFACTURER American National Red
Cross, New England Region, Dedham, MA
REASON Platelets, which were possibly
contaminated with coagulase negative Staphylococcus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Platelets Pheresis,
Irradiated
CODE Unit number:
06KR35274
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood product, with elevated platelet counts, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
1249550
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON
Platelets, with a low yield, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT
a) Fresh Frozen
Plasma
b) Recovered Plasma
CODE
a) Unit number 4835787;
b) Unit number
4642919
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc.,
Orlando, FL
REASON Blood products,
collected from a donor who was at increased risk for variant Creutzfeldt-Jakob
Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 3178210
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, which was collected from a donor in which
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Source Plasma
CODE
Unit numbers: G20953014, G21541014, G21942014,
G22813014, G23670014, G24004014, G25274014, G25494014, G26751014, G26999014, and
G27681014
RECALLING FIRM/MANUFACTURER Alpha Therapeutics
Corporation, National City, CA, REASON Blood products, which were collected
from a donor who was previously deferred for high risk behavior, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION Spain
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit number: 40FY44368;
b)
Unit number: 40FP22168
RECALLING FIRM/MANUFACTURER American Red
Cross Blood Services, Peoria, IL
REASON Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
LW12295
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON
Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced
b) Platelets Pheresis,
Leukocytes Reduced
CODE
a) Unit numbers:
18238-5378, 18238-7088, 18238-7097;
b) Unit numbers: 18238-6876,
18238-7088
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Cheyenne, WY,
REASON
Blood products, collected in apheresis
collection kits that may have exceeded the acceptable time period for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION WY
PRODUCT Platelets
CODE
Unit number: L94697
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT Platelets
CODE
Unit number: N25356
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT Red Blood Cells
CODE
Unit number: S84804
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI
REASON
Blood product, labeled with an incorrect
expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
04FJ43633
RECALLING FIRM/MANUFACTURER American National Red Cross,
New England Region, Dedham, MA
REASON Blood products,
which tested negative for the antibody to the human immunodeficiency virus
(anti-HIV-1/2), but were collected from a donor who was subsequently determined
to have previously tested positive for HIV, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MA
PRODUCT Red Blood Cells
CODE
Unit number: 4167724
RECALLING
FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood product,
collected from a donor who did not have a hematocrit test during the donor
screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells
CODE
Unit numbers: 18X74361, 18X74362,
18X74363
RECALLING FIRM/MANUFACTURER American National Red Cross,
Great Lakes Region, Lansing, MI
REASON Blood products, for which the storage
temperature of the donor thermometers exceeded the acceptable limit, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells
b) Recovered
Plasma
CODE a) and b) Unit numbers: 03GK31284,
03LR49415
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood products, collected from an
ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA
PRODUCT Red Blood Cells
CODE
Unit number: S47299
RECALLING
FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product,
untested for the antibody to hepatitis B core antigen (anti-HBc), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit
numbers: 16KF48433
RECALLING FIRM/MANUFACTURER American National
Red Cross, Central Ohio Region, Columbus, OH
REASON Blood products, for which platelet cross-match
testing was incorrectly performed, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Fresh Frozen Plasma (Apheresis)
CODE
Unit number:
36N05072
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC
REASON Fresh Frozen Plasma, labeled
with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT Six Bag Aliquot System
with piercing pin and injection site; Size 150 mL,
CODE Product Code T2186; Lot 109851
RECALLING
FIRM/MANUFACTURER Charter Medical Limited, Winston Salem, NC
REASON
Transfer packs, mislabeled with an incorrect bag
volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,464
units
DISTRIBUTION CA, FL, IL, and OH
PRODUCT Red Blood Cells
CODE
Unit number: 06FS93865
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood product, collected in an expired collection
bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit numbers: 06FM23362, 06FM23387
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA,
REASON Blood products, collected in expired collection
bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ and CA
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced
CODE Unit number:
33GN02171
RECALLING FIRM/MANUFACTURER American National Red Cross,
Connecticut Region, Farmington, CT.
REASON Blood product, which 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.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CT
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number: 211FM47855
-- split product
RECALLING FIRM/MANUFACTURER American National Red
Cross, Southern California Region, Pomona, CA
REASON Platelets,
possibly contaminated with Bacillus sphaericus, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocyte Reduced
CODE Unit numbers: 211FM37798
-- split unit
RECALLING FIRM/MANUFACTURER American National Red
Cross, Southern California Region, Pomona, CA
REASON Platelets, possibly contaminated with Bacillus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced Irradiated
CODE Unit number:
FH02840
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
REASON Blood product, which was
labeled with an incorrect expiration date, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Recovered Plasma,
CODE
Unit number: 04FJ43633
RECALLING
FIRM/MANUFACTURER American National Red Cross, New England Region,
Dedham, MA
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who was subsequently determined to have previously tested positive
for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit number:
1253053
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON
Blood product, which was irradiated twice, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
WEEK ENDING APRIL 15
PRODUCT Human Tissue for Transplantation,
a) Alloquent CC
allograft (8, 9, & 10 mm) Amended to include 5, 6, and 7 mm;
b) Achilles
Tendon;
c) Cancellous, 4-10 mm (15 cc & 30
cc);
d) Patella Tendon-Hemi;
e)
Tibialis Tendon;
f) Iliac Crest Wedge (14-17mm, 11-13 mm, <10
mm and 18+mm);
CODE
a) Product Code: BS30-4008, ID# :
GL2005-180-001, GL2005-180-002, GL2005-180-003, GL2005-180-004, GL2005-180-005,
GL2005-180-006, GL2005-180-007, GL2005-180-008, GL2005-180-009; Amended
to include: ID# : GL2005-139-013, GL2005-139-014, GL2005-176-001,
GL2005-176-002, GL2005-176-003, GL2005-179-001, GL2005-179-002, GL2005-179-003,
GL2005-179-004, GL2005-183-001, GL2005-183-002, GL2005-183-003, GL2005-183-004
Product Code: BS30-4009, ID#: GL2005-180-010; Amended to
include: GL2005-127-015, GL2005-139-015, GL2005-143-012,
GL2005-176-004, GL2005-176-005, GL2005-176-006, GL2005-176-007, GL2005-176-008,
GL2005-176-009, GL2005-176-010, GL2005-179-007, GL2005-179-008, GL2005-179-009,
GL2005-183-005, GL2005-183-006, GL2005-183-007, GL2005-183-008, GL2005-183-009,
GL2005-183-010
Product Code: BS30-4010, ID#: GL2005-147-020, L2005-147-021,
GL2005-161-017, GL2005-161-018, GL2005-164-013, GL2005-164-014, GL2005-165-015,
GL2005-167-013, GL2005-167-014, GL2005-167-015, GL2005-167-016, GL2005-167-017,
GL2005-168-013, GL2005-168-014, GL2005-168-015, GL2005-168-016; Amended
to include: GL2005-139-016, GL2005-127-016, GL2005-143-013,
GL2005-159-013, GL2005-181-018
Amended to include: Product
Code BS30-4005, ID#: GL2005-133-005, GL2005-139-010, GL2005-143-008;
Product
Code: BS30-4006, ID#: GL2005-127-010, GL2005-133-006, GL2005-133-007,
GL2005-143-009, GL2005-143-010;
Product Code: BS30-4007, ID#:
GL2005-127-011, GL2005-127-012, GL2005-127-013, GL2005-127-014, GL2005-133-008,
GL2005-133-009, GL2005-139-011, GL2005-139-012, and GL2005-143-011
b) Product Code: LATM, ID#: GL2005-107-001, GL2005-108-001, GL2005-108-002, GL2005-109-001, GL2005-109-002, GL2005-114-002, GL2005-116-002, GL2005-118-001, GL2005-119-001, GL2005-119-002, GL2005-124-002, GL2005-130-001, GL2005-115-002, GL2005-116-001, GL2005-114-001, GL2005-120-003, GL2005-118-002, GL2005-124-001, and GL2005-115-001
c) Product Code: LCIPM, ID#: GL2005-107-003, GL2005-111-004,
GL2005-113-004, GL2005-114-004, GL2005-115-004, GL2005-116-004, GL2005-122-004,
T2005-034-005, T2005-049-014, T2005-064-003, T2005-078-005, T2005-057-002,
T2005-072-003, GL2005-139-009
Product Code: LCISM, ID#: T2005-040-013,
T2005-040-014, T2005-040-015, T2005-040-016, GL2005-108-003, GL2005-109-003,
GL2005-111-003, GL2005-114-003, T2005-034-003, T2005-034-004, T2005-039-003,
T2005-039-004, T2005-039-005, T2005-040-007, T2005-040-017, T2005-041-008,
T2005-041-009, T2005-041-010, T2005-041-011, T2005-041-012, T2005-041-017,
T2005-043-005, T2005-043-006, T2005-043-007, T2005-045-008, T2005-045-009,
T2005-045-010, T2005-045-011, T2005-045-012, T2005-045-017, T2005-048-008,
T2005-048-009, T2005-048-010, T2005-048-011, T2005-048-012, T2005-048-013,
T2005-049-009, T2005-049-012, T2005-051-001, T2005-052-001, T2005-053-003,
T2005-054-003, T2005-055-003, T2005-056-001, T2005-059-002, T2005-059-003,
T2005-060-001, T2005-061-004, T2005-062-001, T2005-062-002, T2005-063-003,
T2005-064-001, T2005-064-002, T2005-065-001, T2005-066-001, T2005-067-001,
T2005-068-003, T2005-069-003, T2005-075-003, T2005-078-003, T2005-078-004,
GL2005-107-002, GL2005-109-004, GL2005-110-004, GL2005-113-003, GL2005-115-003,
GL2005-116-003, GL2005-117-003, GL2005-117-004, GL2005-118-003, GL2005-118-004,
GL2005-120-001, GL2005-120-002, GL2005-122-003, GL2005-123-003, GL2005-123-004,
GL2005-123-005, GL2005-124-003, GL2005-124-004, GL2005-127-007, GL2005-130-003,
GL2005-139-007, GL2005-139-008, T2005-038-003, T2005-040-008, T2005-045-013,
T2005-045-014, T2005-045-015, T2005-045-016, T2005-045-018, T2005-045-019,
T2005-046-010, T2005-046-011, T2005-046-013, T2005-047-016, T2005-047-017,
T2005-049-010, T2005-049-013, GL2005-119-003, GL2005-119-004, T2005-038-004,
T2005-040-009, T2005-040-010, T2005-040-011, T2005-040-012, T2005-044-014,
T2005-044-015, T2005-047-011, T2005-047-012, T2005-047-013, T2005-047-014,
T2005-047-015, T2005-048-007, T2005-048-014, T2005-070-001, T2005-071-001,
T2005-073-001, T2005-074-003, T2005-043-016, T2005-044-009, T2005-057-001,
T2005-058-001, T2005-059-001, T2005-012-003, T2005-012-004, T2005-012-005,
T2005-012-006, T2005-014-001, T2005-014-002, T2005-014-003, T2005-014-004,
T2005-014-005, T2005-014-006, T2005-015-001, T2005-015-002, T2005-015-003,
T2005-015-004, T2005-015-005, T2005-016-001, T2005-016-002, T2005-016-003,
T2005-016-004, T2005-016-005, T2005-016-006, T2005-016-007, T2005-019-001,
T2005-019-002, T2005-019-003, T2005-019-004, T2005-020-001, T2005-020-002,
T2005-020-003, T2005-020-004, T2005-020-005, T2005-020-006, T2005-021-001,
T2005-021-002, T2005-021-003, T2005-021-004, T2005-021-005, T2005-021-006,
T2005-022-003, T2005-022-004, T2005-022-005, T2005-022-006, T2005-022-007,
T2005-022-008, T2005-022-009, T2005-022-010, T2005-023-003, T2005-023-004,
T2005-023-005, T2005-023-006
d) Product Code: LPTHM (Amended from LTTM), ID#: GL2005-147-003
e) Product Code: LTTM, ID#: GL2005-180-015, GL2005-183-014, GL2005-146-004, GL2005-133-014, GL2005-139-004, GL2005-139-005, GL2005-143-005, GL2005-143-006, GL2005-146-003, GL2005-161-003, GL2005-161-004, GL2005-164-003, GL2005-164-004, GL2005-167-003, GL2005-167-004, GL2005-168-004, GL2005-176-013, GL2005-176-015, GL2005-176-016, GL2005-179-012, GL2005-179-013, GL2005-179-015, GL2005-180-013, GL2005-180-014, GL2005-183-013, GL2005-183-016, Amended to include: ID#.GL2005-158-003, GL2005-158-004, GL2005-159-004
f) Product Code: LIWLM, ID#: T2005-034-008, T2005-038-005, T2005-010-009,
T2005-019-010, T2005-020-010, T2005-021-014, T2005-022-019, T2005-022-020,
T2005-023-011, T2005-023-012, T2005-038-009;
Product Code: LIWMM, ID#:
T2005-021-010, T2005-021-011;
Product Code: LIWSM, ID#: T2005-010-002,
T2005-015-006;
Product Code: LIWXLM, ID#: T2005-034-007,
T2005-045-023, T2005-045-024, T2005-045-022, T2005-034-006,
T2005-045-020
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Lost Mountain Tissue Bank, Kennesaw, GA
Manufacturer:
Biomedical Tissue Services, Ltd., Fort Lee, NJ.
REASON Human tissues, procured from donors
without adequate donor eligibility determinations, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 337
tissues
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE
a) and b) Unit numbers:
06FW75154, and 06FW78487
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood products, which 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 4
units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells, Irradiated
b) Platelets
CODE a) and b) Unit number:
4127145
RECALLING FIRM/MANUFACTURER Community Blood
Center, Dayton, OH
REASON Blood products, collected from an
unsuitable donor who had traveled to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit numbers: 9040689, 9041609, and
9041611
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Greenville, NC
REASON Platelets, not manufactured according to
firm specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE
a) and b) Recall #
12FN59020
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from an
ineligible donor, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NC and
MA
PRODUCT BacT ALERT Classic 120 System and 240
System
CODE All Models
RECALLING
FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC
REASON
BacT/ALERT Classic Systems, with a
software glitch or defect, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3,531 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Fresh
Frozen Plasma
CODE a) and b) Unit
number: 12FG08634
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Charlotte, NC,
REASON Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Red Blood Cells, Leukocytes
Reduced
CODE Unit number: 12LW87797
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC, REASON
Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit number: 12Y52574
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC, REASON
Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis Leukocytes
Reduced
CODE Unit number:
R84677
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Community Blood Center of the Carolinas, Charlotte, NC
REASON
Blood products, which were collected
from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Plasma, Frozen
CODE
Unit numbers:
003FJ79310, 003GZ61817, and 003GZ61830
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region,
Atlanta, GA
REASON Blood
products, associated with units of Red Blood Cells that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit number:
003KN18899
RECALLING FIRM/MANUFACTURER American National
Red Cross, Southern Region, Atlanta, GA
REASON Blood product, which yielded a platelet
count that was below the acceptable limit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells, Leukocytes
Reduced
CODE Unit number: GM13510
RECALLING
FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside
Counties, San Bernardino, CA,
REASON Blood product, collected from
a donor who had lived in an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
Irradiated,
CODE Unit number:
126456483
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Albuquerque, NM
REASON Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NM
PRODUCT Platelets Pheresis Leukocytes
Reduced
CODE Unit number: 03FK41070 (double
unit)
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Atlanta, GA, REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit
number: 03P51460
RECALLING FIRM/MANUFACTURER American
National Red Cross, Southern Region, Atlanta, GA
REASON Platelets, labeled as
leukoreduced, but
did not meet the requirements for a leukoreduced product, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT The
Operator’s Manual for the Baxter Fenwal Amicus Separator Apheresis Device, Amicus Separator Accessory kits containing an Operator’s
Manual: Product Code 4R2332
Product Usage: An automated apheresis device
intended for the simultaneous collection of platelet concentrates, plasma and
red blood cells.
- Amicus Separators (New and Refurbished) Product Codes
4R4580 and 4R4580R
CODE All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter Healthcare Corporation / Fenwal, Deerfield, IL
Manufacturer: Baxter Healthcare Corporation, Largo,
FL
REASON Operator’s Manuals
for the Baxter Fenwal Amicus Separator Apheresis Device, containing maintenance
instructions that may cause a potential for red cell hemolysis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3,412
manuals
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Red Blood Cells
b) Fresh Frozen Plasma
CODE a) and b) Unit number:
R82182
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Community Blood Center of the Carolinas, Charlotte, NC
REASON
Blood products, which were collected
from a donor who had taken the medication Toprol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced
CODE Unit number:
012GT31999
RECALLING FIRM/MANUFACTURER American National
Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, which was not
leukoreduced within the appropriate time period after collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Unit number: 0887578
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON Blood product, which was out of controlled
storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced
b) Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE
a)
Unit numbers: GM65615, GM60829, GM92690;
b) Unit numbers: GM70168,
GW42852
RECALLING FIRM/MANUFACTURER Blood Bank of San
Bernardino and Riverside Counties, San Bernardino, CA
REASON
Blood
products, which were labeled leukoreduced, but had an unacceptable white blood
cell count, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5
units
DISTRIBUTION CA
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Fresh Frozen Plasma
c) Plasma
d)
Cryoprecipitated AHF
CODE
a) Unit
numbers: 12FP61590 and 12GS23207;
b) Unit number: 12FP65190;
c) and d)
Unit number: 12GS23207
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON
Blood products, which were
collected from a donor who had taken an anti-viral medication, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION NC, GA, and PR
WEEK ENDING APRIL 22
PRODUCT Human Tissue for
Transplantation: Corneas,
CODE ID numbers:
05-2203, 05-2204
RECALLING FIRM/MANUFACTURER Georgia Eye Bank,
Atlanta, GA
REASON Human Corneas,
inadequately tested for infectious diseases in that the blood sample used for
testing may have been hemodiluted, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 tissues
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Cryoprecipitated AHF,
CODE a) and b) Unit number: 027X21038
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies
Region, Johnstown, PA.
REASON Blood
products, collected from a donor whose health history screening was not
adequately performed, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION WV and MD
PRODUCT Red Blood Cells
CODE
Unit number: 49W47679
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Southwest Region,
Tulsa, OK
REASON Blood products,
collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
and CA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Red Blood Cells Irradiated, ;
c) Red Blood Cells,
d) Red Blood Cells
(Apheresis),
e) Platelets Pheresis Leukocytes Reduced Irradiated,
f) Platelets Pheresis Leukocytes Reduced,
CODE
a) Units: S57275, S57263, S53709, S53715, S55472,
S55483, S55491, S55496,
S55499, S55945, S55953, S55967, S57240, S57262,
S57266, KC87131, KC87134;
b) Unit: S52760;
c) Units: S57279, S55949,
S55973;
d) Units: S57241, S57283, S55966, S57259;
e) Units: S57245,
S57274, S57283, S57243, S55946, S55950;
f) Units: S55966 (split product),
S57241
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem, PA
REASON
Blood products,
tested for CMV with unacceptable QC results, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 34 units
DISTRIBUTION PA
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit 12W03915 (split
unit)
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Charlotte, NC
REASON Blood
products, which were collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit
12KP91034
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Charlotte, NC
REASON Blood product,
which was collected from a donor who did not meet acceptable hemoglobin
specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit
03KE25187
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Atlanta, GA, REASON Blood product, which was collected from a donor
who had lived in a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced
b) Platelets Leukocytes Reduced
CODE a) and b) Unit 33GS66196
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON
Blood products, which were collected from a donor
who had traveled to a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CT
PRODUCT Recovered
Plasma
CODE Unit number: 49W47679
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Southwest Region,
Tulsa, OK
REASON Blood products,
collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
and CA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit 7380492;
b) Unit 0157063
RECALLING
FIRM/MANUFACTURER Marquette General Hospital, Marquette, MI
REASON
Blood products, which were collected from a donor
who had a history of arthritis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MI and FL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit: 36GR11627
RECALLING FIRM/MANUFACTURER The American National Red Cross, South
Carolina Region, Columbia, SC
REASON Blood product, collected from a donor
at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT
a) Cryoprecipitated
AHF,
b) Plasma Cryoprecipitate Reduced,
CODE a) and b) Unit 12FG10650
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON
Blood products, which were not collected
in accordance with standard operating procedures, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA and
NC
WEEK ENDING APRIL 29
PRODUCT Source Plasma
CODE
Unit number: 0370521116
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc, Medford, OR
REASON Blood product, which was collected from a donor
that subsequently was determined to have an unreported body piercing, was
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 4232511,
4232493 (part of split product)
RECALLING FIRM/MANUFACTURER Florida
Blood Services, Inc., St. Petersburg, FL
REASON Blood products, collected
using equipment that had not been validated for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
012GF17754
RECALLING FIRM/MANUFACTURER American Red Cross,
Carolinas Blood Services Region, Charlotte, NC
REASON Red Cells, prior to completion of validation
studies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
36FG26262
RECALLING FIRM/MANUFACTURER The American National Red
Cross, South Carolina Region, Columbia, SC
REASON Blood product, collected from a donor previously
diagnosed with lymphoma, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced Irradiated
b) Platelets Pheresis
Leukocytes Reduced
c) Red Blood Cells
CODE
a) Unit numbers: B212072 (split product), B21179;
b) Unit
number: B21179;
c) Unit number: Z110691
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood
products, collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION WA
PRODUCT Fresh
Frozen Plasma
CODE Unit number:
71Q93466-3
RECALLING FIRM/MANUFACTURER Life South Community Blood
Center, Dunwoody, GA
REASON Blood product, corresponding to a unit of clotted
red blood cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit number: 12KP84231
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood products, which tested negative for anti-HCV, but were collected from an ineligible donor who previously tested
repeat reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA and GA
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit number:
36Y75006
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC
REASON Blood product, collected from an ineligible donor
due to use of the medication Lupron, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
04R34997
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Dedham, MA
REASON Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
04LQ29358
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Dedham, MA
REASON Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
06GF83952
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Pomona, CA, REASON Blood product,
which was collected from a donor who had traveled to a malarial endemic area,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
102908081
RECALLING FIRM/MANUFACTURER Blood Systems, Inc,
Scottsdale, AZ
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
06GV14741
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Pomona, CA
REASON Blood
product, which was collected from a donor who had traveled to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Plasma Frozen
CODE a) and b) Unit number: 100485227
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc, Scottsdale, AZ
REASON Blood
products, which were collected from a donor who may be at increased risk for
variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ
PRODUCT
a) Red Blood Cells
b)
Platelets
CODE a) and
b) Unit number: 4356015
RECALLING FIRM/MANUFACTURER Florida Blood
Services, Inc., St. Petersburg, FL
REASON Blood products,
which were collected from a donor in which donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
12KG72874
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas
Blood Services Region, Charlotte, NC.
REASON Platelets, mislabeled as
leukoreduced, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit numbers: G44413, G44415, G44417, G44418,
G44420, G44422, G44424,
G44425, G44426, G44427, G44429, G44431, G44432,
G44434, G44439,
G44440, G44442, G44443;
b) G44411, G44412, G44414,
G44416, G44419, G44421, G44423, G44428,
G44430, G44433, G44435, G44441,
G44445
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Center, Springfield, IL
REASON Blood products, collected from
donors whose hematocrits were not recorded concurrently during screening, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 31
units
DISTRIBUTION IL and LA
PRODUCT Reagent Red Blood Cells
(Referencells A1 and B), Package Size: 2 x 10mL
CODE Lot number: 27461, Expiration Date: September 2,
2005
RECALLING FIRM/MANUFACTURER Immucor, Inc, Norcross, GA
REASON
Reagent Red Blood Cells, containing incorrect
package inserts, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6,588 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Red Blood Cells
CODE
Unit numbers: 0208286; 0208288; 0208290; 0208360;
0208542; 0208552; 0209034; 0208868
RECALLING FIRM/MANUFACTURER The
Blood Connection, Inc., Greenville, SC
REASON Red cells, collected in bags
that had exceed their expiration date, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8 units
DISTRIBUTION GA and SC