FEBRUARY 2006
WEEK ENDING FEBRUARY 4
PRODUCT Human Cornea Tissue
CODE
05-026 OD and 05-026 OS
RECALLING
FIRM/MANUFACTURER Lions Eye Bank of NW Pennsylvania, Inc., Erie, PA, REASON
Human tissues for
transplantation, procured from a donor who tested negative
for antibody to
hepatitis C virus (anti-HCV), but was subsequently found to
have tested
positive for the hepatitis C virus by NAT testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Units 04HPAA1043, SH050157, SH049896, SH049736,
SH047954, SH047654, SH047480, SH047207, SH046991, SH046558, SH046303, SH046142,
SH045838, SH045662, SH045383, SH045212, SH044926, SH044763, SH044533, SH043853,
SH043573, SH043052, SH042630, SH042431, SH042199, SH041974, SH041714, SH041527,
SH041217, SH041031, SH040751, SH040606, SH039804, SH039600, SH036973, SH036759,
SH036462, SH036299, SH036043, SH035838, SH035576, SH035399, SH034633, SH034473,
SH034204, SH034041, SH046760, SH039315, SH039137, SH038665, SH038420, SH037940,
SH037419, SH035066, SH034881, SH033759, SH033564, SH038215, SH037721, SH037242,
SH044322, SH044050, SH043355, SH042882, SH040288, SH040114
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, L.P., Harrisburg, PA
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 COMMERCE66
units
DISTRIBUTION NY, NC and France
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit 8110973 (Part 1)
RECALLING FIRM/MANUFACTURER LifeShare Community Blood Services,
Elyria, OH
REASON Platelets Pheresis, with an unacceptably low
volume, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH
PRODUCT Source Plasma
CODE
Units VL184059, VL183751, VL182164, VL181886,
VL181317, VL181149, VL180319, VL179796, VL179518, VL176982, VL176591, VL176228,
VL175590, VL175153, VL174861, VL174286, VL174073, VL170195, VL169583, VL169286,
VL167285, VL200343, VL200226, VL199778, VL199469, VL199224, VL198934, VL198609,
VL198357, VL198057, VL197871, VL197530, VL197334, VL196997, VL196793, VL196097,
VL195468, VL195243, VL193527, VL193313, VL192741, VL192495, VL192019, VL191805,
VL184793, VL184535, VL167105, VL166766, VL166601, VL166213, VL165995, VL165675,
VL165519
RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP,
Shreveport, LA
REASON Source Plasma, collected from a previously
deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 53
units
DISTRIBUTION NC
PRODUCT Fresh Frozen Plasma
CODE
Unit 6869278
RECALLING
FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ
REASON
Blood product, corresponding to a unit of clotted
Red Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NH
PRODUCT Source Plasma
CODE
Units VL53767, ZZ031076, ZZ030881, ZZ03046,
VL151413, VL151144, VL50837
RECALLING FIRM/MANUFACTURER BioLife
Plasma Services LP, Shreveport, LA
REASON Source Plasma, collected from
a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION NC
PRODUCT Platelets
CODE
Units 6726297,
1310306
RECALLING
FIRM/MANUFACTURER LifeShare Community Blood Services, Elyria, OH
REASON
Blood products, which were stored at unacceptable
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Platelets Pheresis
Leukocytes Reduced, Irradiated
CODE Units
06KY04410
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southern California Region, Pomona, CA,
REASON Platelets, possibly contaminated with
microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit
1021687
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC
Medical Center, Cincinnati, OH
REASON Red Cells, mislabeled as to S antigen
phenotype, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Platelets, Pheresis
Leukocytes Reduced
CODE Unit
GS39156
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino
and Riverside Counties, San Bernardino, CA
REASON Platelets, mislabeled as to
volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Unit SA128214
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON
Blood product, collected from a donor whose arm
inspection was not documentation, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IL
WEEK ENDING FEBRUARY 11
PRODUCT Reagent Red Blood Cells
A1 and B (Pooled Cells) - Referencells,
Package Size: 2 x 10mL, 4 x 10mL,
and 50 x 10mL (unlabeled for export)
CODE Lot
Numbers 09092 & 09092A
Expiration Date: April 29, 2005
RECALLING
FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Reagent Red Blood
Cells, with varying hematocrits, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8,556 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Source Plasma
CODE
Unit numbers: HS0045656, HS0045884, HS0046368
RECALLING FIRM/MANUFACTURER DCI Biologicals Hot Springs, LLC, Hot
Springs, AR
REASON Blood products, which were not properly
quarantined after receiving post donation information concerning high-risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION KY
PRODUCT Source Plasma
CODE
Unit number: 05MOHA6472
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, L.P., Lima, OH
REASON Blood
product, which was not properly quarantined after receiving post donation
information concerning a history of incarceration, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit number: 0835389
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON
Red Blood Cells, mislabeled as to Rh type, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Red Blood Cells
CODE
Unit number: 06LV67954
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood product, collected from
a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit number: 06LW41246
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA.
REASON Blood product, collected from
a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Unit
number 04LC17193
RECALLING FIRM/MANUFACTURER American National Red
Cross, New England Region, Dedham, MA
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 ME
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number
18N97894
RECALLING FIRM/MANUFACTURER American National Red Cross,
Great Lakes Region, Lansing, MI
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 MI
PRODUCT
a) Platelet Pheresis,
Leukocytes Removed,
b) Platelet Pheresis, Leukocytes
Removed, Irradiated
CODE
a) Unit numbers:
04KE47255 (part 1), 04KE46390 (part1), and 04KE44868 (part1);
b) Unit
number 04KE46390 (part1)
RECALLING FIRM/MANUFACTURER American
National Red Cross, New England Region, Dedham, MA
REASON Blood
products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION ME, MA and NY
PRODUCT Red Blood Cells Pheresis
CODE
Unit numbers:
18GJ85709
RECALLING FIRM/MANUFACTURER American National Red Cross,
Great Lakes Region, Lansing, MI
REASON Blood products, collected in a manner
that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI
PRODUCT Red Blood Cells Pheresis, Leukocytes
Reduced
CODE Unit number:
04KJ05081 (Part I)
RECALLING FIRM/MANUFACTURER American National
Red Cross, New England Region, Dedham, MA.
REASON Blood
products, collected in a manner that may compromise the sterility of the
product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Unit
number: 027GX95980
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood product, for
which documentation of irradiation was incomplete, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
113396242
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX
REASON
Blood product, collected from a donor whose health
history screening was inadequately performed, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION New
Mexico
PRODUCT Red Blood Cells
CODE
Unit number: 5161741
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, East Orange, NJ
REASON
Blood product, collected from an ineligible donor
due to a history of hemochromatosis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Cryoprecipitated AHF
CODE
Unit number: LH24339
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, Inc., Dba Rhode Island
Blood Center, Providence, RI
REASON Blood product, which may have reached an
unacceptable temperature during storage, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
20LH04051
RECALLING FIRM/MANUFACTURER American National Red Cross,
Lewis and Clark Region, Boise, ID
REASON Blood product, which was
stored at an incorrect temperature, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OR
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: 20LC35696, 20LC28822, 20LC31834,
20LC22679;
b) Unit numbers: 20LC47618, 20LC44420,
20LC18525
RECALLING FIRM/MANUFACTURER American National Red Cross,
Lewis and Clark Region, Boise, ID
REASON Blood products, collected from
an unsuitable donor due to a history of hemochromatosis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA, ID, OR, PA, and UT
WEEK ENDING FEBRUARY 18
PRODUCT
Human Tissue for
Transplantation
CryoGraft, Lateral Meniscus-Bone
Left;
CryoGraft, Semitendinosus/Gracilis Tendon;
CryoGraft, Tibialis
Tendon
CODE Unit numbers: 7266180, 7266176, 7265993
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissues, associated with complaints of recipient
infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
tissues
DISTRIBUTION CA, CO, GA, IL, MI, MO, NV, PA, TX, UT, and
VA
PRODUCT
CryoVein, Femoral Vein,
CryoVein, Saphenous Vein,
CryoGraft, Pericardium
CODE Tissue numbers: 7980084, 7987683, 8040669
RECALLING
FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissues for transplantation, procured from
donors for whom the companion sample from a different site was positive for
microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
tissues
DISTRIBUTION FL, GA, and NY
PRODUCT Human Tissue for
Transplantation
CryoGraft, Achilles Tendon;
CryoGraft,
Hemi Patellar Tendon;
CryoGraft, Tibialis Tendon;
CryoVein, Saphenous
Vein;
CryoVein, Femoral Vein with Valve;
CryoVein, Femoral Vein SG
CODE Unit numbers: 7193219, 6676523, 7209164, 7189821, 6565379,
7076122, 7187980, 6688659, 7408841
RECALLING
FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissues, associated with complaints of recipient
infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
tissues
DISTRIBUTION CA, CO, GA, IL, MI, MO, NV, PA, TX, UT, and
VA
PRODUCT Cryoprecipitated AHF
CODE
Unit number: 6870437
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ
REASON
Blood product, that may have contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Platelet Pheresis
Leukocytes Reduced
CODE Unit number: 2822036
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource,
Glenview, IL
Manufacturer:
LifeSource Norridge, Norridge, IL.
REASON Blood product, contaminated with Staphylococcus
epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Cryoprecipitated AHF
CODE
Unit number: 2100748
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center Inc., Lexington, KY
REASON
Blood product, corresponding to a unit of Red
Blood Cells Leukoreduced that were contaminated with Staphylococcus aureus and
implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Source Plasma
CODE
Unit numbers: 04MINB2058, 04MINB2492, 04MINE3631,
05MINA0118, 05MINA0916, 05MINA1192, 05MINA1760, and 05MINA2250
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, LP, Muncie, IN
REASON Blood
products, which were collected from a donor who had a history of receiving a
tattoo within twelve months of the donations, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8 units
DISTRIBUTION CA and NC
PRODUCT Source Plasma
CODE
Unit numbers: 0200280783, 0200280653, and 0200278423
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Norman, OK
REASON
Blood products, which were collected from a donor
in which suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION KY
PRODUCT Source Plasma
CODE
Unit numbers: KLN012294, KLN012436, KLN012734,
KLN012930, KLN013204, KLN013566, KLN013965, KLN014124, KLN014446, KLN014670,
KLN015078, KLN015313, KLN015995, KLN016235, 0150000377, 0150001161, 0150001502,
0150002036, 0150002120, 0150002742, 0150002968, 0150003516, 0150004120,
0150004371, 0150005017, 0150005300, 0150005872, 0150008344, 0150008597,
0150009346, 0150009652, 0150010407, 0150010642, 0150011560, 0150011853,
0150012440, 0150012779, and 0150013294 [
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., Kalamazoo, MI
REASON Blood products, which were collected from a donor
in which suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 38
units
DISTRIBUTION Spain
PRODUCT Red Blood Cells Leukocytes
Reduced
CODE Unit number: R38790
RECALLING
FIRM/MANUFACTURER South Bend Medical Foundation, Inc., South Bend, IN
REASON
Blood product, which was incorrectly used for the
hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IN
PRODUCT
a) Red Blood Cells
b) Recovered Plasma,
CODE
a) Unit numbers: 122134238, 182095664, 182100934,
182115897, 182123958, 182142593, and 182148636;
b) Unit numbers:
122134238, 182095664, 182100934, 182115897, 182123958, 182142593, and
182148636
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Cheyenne, WY
REASON Blood products, which tested negative for the
antibody to the hepatitis C virus encoded antigen (anti-HCV) but were collected
from a donor who had previously tested repeatedly reactive for anti-HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION IL, NB, TX, WY, Austria and Switzerland
PRODUCT Red Blood Cells
CODE
Unit number: 5123019
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, East Orange, NJ
REASON Blood product, associated with a unit of Fresh Frozen
Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
CODE
Unit number: 6212498
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, East Orange, NJ
REASON Blood product, associated with a unit of Fresh Frozen
Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 06LF56125
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
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 2 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
b)
Recovered Plasma
CODE a) and b) Unit number: 06GH52625
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor who was previously deferred due to a
history of non-sexual exposure to Hepatitis B, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA and
Switzerland
PRODUCT
a) Red Blood Cells
b)
Platelets
c) Recovered Plasma
CODE
a) Unit numbers: 06LV10862, 06FL56970,
06FL43899, 06FL41862, 06FL39033;
b) Unit number: 06FL56970;
c) Unit
numbers: 06LV10862, 06FL62327, 06FL56970, 06FL43899, 06FL41862,
06FL39033
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor who was previously deferred for a
history of hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 12 units
DISTRIBUTION CA
PRODUCT
Human Tissue for
Transplantation
a) Hemi Patella Tendon Tissues;
b) Achilles Tendon
Tissue;
c) Tibialis Tendon Anterior;
d) Tibialis Tendon Posterior;
e) Femoral Head/Neck
CODE
a) Tissue
numbers: 057019-005, 057019-006, 057019-007, 057019-008;
b) Tissue
number: 057019-003;
c) Tissue numbers: 057019-013, 057019-014;
d) Tissue
numbers: 057019-011, 057019-012;
e) Tissue numbers: 057019-025,
057019-026
RECALLING FIRM/MANUFACTURER Bone Bank Allografts, San
Antonio, TX.
REASON Human tissues,
recovered from a donor with discordant Hepatitis B Virus (HBsAg) test results,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION AK, AZ, IL, IN, MD, OK, and PA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Plasma, Frozen
CODE a) and b) Unit numbers: 10043-5297,
10759-3902
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, collected from an ineligible donor
due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION AZ
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 35P43398,
35P43400, 35P43401, 35P43402, 35P43404, 35P43406, 35P43407, 35P47868, 35P47872,
35P47873, 35P47875, 35P47876, 35P47879, 35P47882, 35P47885, 35P47887, 35P47889,
35P47890, 35P47891, 35Z14793 (split unit), 35Z14796, 35Z14798, 35Z16900,
35Z16901 (split unit), 35Z16902
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON Platelets, which were not stored under continuous
agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 27
units
DISTRIBUTION NJ and PA
PRODUCT Source Plasma
CODE
Unit number: SA135000
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, 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 IL
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit number:
21KP54905
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American National Red Cross, Lewis and Clark Region, Boise, Id
Manufacturer:
American National Red Cross, Great
Falls, MT.
REASON Platelets,
which were not stored under continuous agitation and controlled temperature,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MT
WEEK
ENDING FEBRUARY 25
PRODUCT
Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 0749041,
0749042, 0749044, 0749045, 0749046, 0749047, 0749048, 0749050, 6179068, 6179069,
6179070, 6179072, 6179075, 6179078, 6179079, 6179080, 6179081, 6179086, 6179089,
6179090, 6179092, 6179351, 6179352, 6179358, 6179360, 6179361, 6179362, 6179363,
6179778, 6179781, 6180112, 6180113
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood
products, incorrectly tested for antibody to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
32
units
DISTRIBUTION CO, NY, FL, MS, and VA
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated
CODE
a) Unit numbers:
GS44538, GS47010, GS49338, GS49894, GS49909, GS55029, GS55040, GS55096,
GS49935, GS44805;
b) Unit numbers: GS44613, GS46583, GS55004, GS55019, GS55117
RECALLING FIRM/MANUFACTURER
Blood Bank of San
Bernardino and Riverside Counties, San Bernardino, CA
REASON Blood products,
with a low platelet count, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 15 units
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit number 7154369
RECALLING
FIRM/MANUFACTURER Florida Blood Services, Inc., Bradenton, FL
REASON
Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number
113445944
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, El Paso, TX
REASON
Blood product, which was incorrectly tested for
syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NM
PRODUCT
a) Red Blood Cells
b) Recovered
Plasma
CODE a) and b) Unit number: D147235
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood
products, collected from a donor in which donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION Austria and WA
PRODUCT Source Plasma
CODE
Unit number: RZ007153
RECALLING
FIRM/MANUFACTURER Bio-Blood Components, Inc., Hammond, IN
REASON Blood product, that tested elevated for Alanine
Aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Austria
PRODUCT Source Plasma
CODE
Unit numbers: RM135330, RM135158, RM134910, RM134723,
RM124751, RM124573, RM124279, RM127410, RM127219, RM127009, RM126538, RM126207,
RM125955, RM125799, RM124067, RM123787, RM123544, RM123242, RM123066, RM122759,
RM122567, RM122317, RM122058, RM121829, RM121559, RM121303, RM121129, RM119718,
RM119575, RM119271, RM118758, RM118559, RM118275, RM118084, RM117792, RM117582,
RM117376, RM117143, RM116868, RM116613, RM116337, RM116046, RM115857, RM115631,
RM115428, RM112983, RM111224, RM110950, RM110680, RM110425, RM110067, RM109859,
RM109328, RM108863, RM108257
RECALLING FIRM/MANUFACTURER BioLife
Plasma Services LP, Hattiesburg, MS
REASON Source Plasma,
collected from a previously deferred donor, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 55 units
DISTRIBUTION NC, CA, and VA
PRODUCT
Human Tissue for
Transplantation
a) CryoGraft, Ascending Thoracic Aorta;
b) CryoGraft, Descending Thoracic Aorta;
c) CryoGraft, Peroneus Tendon;
d) CryoGraft, Pulmonary Artery SG;
e) CryoGraft, Quadriceps Tendon;
f) CryoGraft, Tibialis Tendon;
g) CryoPatch, Pericardium;
h)
CryoPatch, Pulmonary Hemi-Artery;
i) CryoPatch, Pulmonary Monocusp
Hemi-Artery;
j) CryoVein, Femoral Vein;
k) CryoVein, Saphenous Vein
CODE
a) Tissue 6170579;
b) Tissue 8026244;
c) Tissues
8006123, 8006139, 8013723, 8069253, 8033748, 8033824;
d) Tissue
7988025;
e) Tissues 8033835, 4119355;
f) Tissues 8026292, 8026251,
8021192, 8021180, 8025826, 8025816, 7960138, 7960151, 7960120,
7960142;
g) Tissue 80473335;
h) Tissue 8366898;
i) Tissue
8026238;
j) Tissue 7972025;
k) Tissues 8025321, 8042392,
6201504
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON
Human tissues for transplantation, recovered from a
donor for whom the companion sample from a different site was positive for
microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 28
tissues
DISTRIBUTION Nationwide
PRODUCT Red Blood Cells
CODE
Unit number: 7614244
RECALLING
FIRM/MANUFACTURER Florida Blood Services Inc., Bradenton, FL
REASON
Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated
CODE Unit numbers:
16KF49520 (split)
RECALLING FIRM/MANUFACTURER The American National
Red Cross, Central Ohio Region, Columbus, OH.
REASON Blood products, which were collected in an
apheresis collection kit that may have exceeded the acceptable time period for
use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated
CODE
a) Unit numbers:
20FR13403, 20FR13416 (2 units), 20FR13420, 20FR13422, 20FR13426, 20FR13427,20FR13429, 20FR13430, 20FR13433, 20FR13440,
20FR13443, 20FR13446,
20P19865 (2 units), 20P19880 (2 units), 20P19885, 20P19891,
20P19894, 20P19900 (2 units), 20P19905, 20P19913, 20P19927, 20P19943,
20P19952 (2 units), 20P19966, 20P19988 (2 units), 20P20008 (2 units),
20P20091;
b) Unit numbers: 20FR13411, 20FR13451, 20P19885, 20P19905,
20P19977
RECALLING FIRM/MANUFACTURER American National Red Cross,
Lewis and Clark Region, Boise, ID
REASON Blood products, collected
using automated equipment that was not validated for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 39
units
DISTRIBUTION ID, MT, and UT
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 04KK04254,
04KK04258, 04KK04259, 04KQ48944, 04KQ48945, 04KQ49017, 04KQ49030, 04KQ49034,
04KQ49036, 04KT77257, 04KT77259, 04KT77264, 04KT77266, 04KT77268, 04KT77269,
04KT77272, 04KT77276, 04KT77283, 04KT77284, 04KT77289, 04KT77387, 04KT77393,
04KT77395, 04KT77399, 04KT77406, 04KT77414, 04KK04248
RECALLING
FIRM/MANUFACTURER American National Red Cross, New England Region,
Dedham, MA.
REASON Blood products,
collected from donors whose arm scrubs may have been incorrectly performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 27
units
DISTRIBUTION CA, MA, ME, NH, NY, and Vermont
PRODUCT Recovered Plasma
CODE
Unit numbers: R170537, R165863, and
R158308
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center,
Seattle, WA
REASON Blood products, which were collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3
units
DISTRIBUTION Austria
PRODUCT Human Tissue for
Transplantation
a) Achilles Tendon;
b) Lordotic ASR Cortical-Cancellous Block;
c) Cancellous Chips (4-10 mm) 30 cc
CODE
a) allograft numbers: 2886064, 2886065;
b) allograft
numbers: 2857241, 2857242, 2857243, 2857244, 2857245, 2857246, 2857247,
2857248, 2857249, 2857250, 2857251, 2857252, 2857253, 2857254, 2857255,
2857256;
c) allograft numbers: 2857257, 2857258, 2857259, 857260,
2857261
RECALLING FIRM/MANUFACTURER Southeast Tissue Alliance,
Inc., Gainesville, FL
REASON Human tissue, recovered from a
donor in which infectious disease testing was performed with an invalid testing
specimen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 23
allografts
DISTRIBUTION FL, TN, and Korea
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: GQ47665,
GW56060, GN37778, GN39004, GX84436, GQ47675, GN35664, GN35656, Y90950, GN36857,
GQ47527, GN29994, GN35901, GN36789, GN35895, GX84218, GN36347
RECALLING
FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties,
San Bernardino, CA.
REASON Blood products, which were exposed to unacceptable
temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 17 units
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit number: 182J10355
RECALLING
FIRM/MANUFACTURER American National Red Cross, Great Lakes Region,
Lansing, MI
REASON Blood product, which was shipped at an
unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers:
11347-1394 (splits 1, 2, 3), 11347-1395 (splits 1,2,3), 11347-4202 (split
1,2,3), 11347-4206 (split 1,2,3)
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., dba United Blood Services, El Paso, TX
REASON Platelets, not
manufactured according to manufacturer’s specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION CO, NM, and TX
PRODUCT Source Plasma
CODE
Unit number SP151077
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, 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 Austria
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 4836761,
4836762, 4836764, 4836765, 4836766, 4836767, 4836769, 4836770, 4836771, 4836773,
4836774, 4836775
RECALLING FIRM/MANUFACTURER Northwest Florida
Blood Center, Inc., Pensacola, FL
REASON Blood products, collected from donors whose
temperatures had been taken using an unapproved method, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit number
6867900
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center,
Inc., Amarillo, TX
REASON Platelets, which were irradiated twice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX