JUNE 2004

WEEK ENDING JUNE 5.

PRODUCT Source Plasma.
CODE Unit numbers 81982783, 81979752, 81971596, 81969128, 81965465, 81962976, 81959853, 81958184, 81948178, and 81946310.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Baton Rouge, LA.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a reactive viral marker test, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells.
CODE Unit number FE87873.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
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 VA.

PRODUCT Red Blood Cells.
CODE Unit number KT26583.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
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 VA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.

CODE Unit number L94923.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) Unit numbers T77427 and T77420;
b) Unit numbers K86146 and T77427.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA.

PRODUCT Cryoprecipitated AHF.
CODE Unit number: L95498.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Source Plasma.
CODE Unit numbers: 0069302, 0069478, 0069923, 0070090, 0075043, 0075384, and 0078620.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX.
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 7 units.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 113384590, 113386133 .
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
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 TX, NM, and Switzerland.

PRODUCT Source Plasma.
CODE Unit numbers: OT242376, OT242158, OT241549, OT240783, OT235322, OT230163, OT229673, OT228886, OT228391, OT226135, OT225565, and OT225229.

RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Inc., Odessa, TX.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18233-3516.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer:  Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 11333-5567.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
REASON Blood product that failed to meet the minimum specification for product volume was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 16KF40718.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Ohio Region, Columbus, OH.
REASON Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Source Plasma.
CODE Unit numbers 02DOHA1853, 02DOHA2202, 02DOHA2830, 02DOHA3192, and 02DOHA3534.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Dayton, OH.
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 042X83368.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 042KP10144.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Platelets, Pheresis.
CODE Units: 53LF72709 53LT78293 53LF72447 53LF72634 53LF72818 53LF72373 53GK31078 53LT78170 53LF72448 53LF72448 53FG08610 53FG08614 53LT78280 53LT78283 53LF72076 53LF72094 53LF72156 53LF72224 53LF72225 53LF72281 53LF72288 53LF72288 53LF72348 53LF72380 53LF72519 53LF72519 53LF72564 53LF72564 53LF72565 53LF72567 53LF72568 53LF72568 53LF72577 53LF72581 53LF72594 53LF72595 53LF72596 53LF72615 53LF72615 53LF72616 53LF72700 53LF72710 53LF72708 53LF72768 53LF72770 53LF72789 53LF72789 53LF72802 53LF72803 53LF72803 53FG08602 53FG08603 53FG08605 53LT78034 53LT78041 53LT78060 53LT78280 53LT78466 53FG08611 53LF72167 53LF72371 53LF72535 53LF72538 53LF72709 53LF72804 53LF72858 53LF72859 53LF72575 53LT78193 53LF72536 53LF72537 53LF72802 53LT78023 53LT78023 53LT78024 53LT78024 53LT78025 53LT78305 53LT78315 53LF72095 53LF72157 53LF72167 53LF72206 53LF72304 53LF72305 53LF72509 53LF72521 53LF72521 53LF72566 53LF72566 53GK31080 53LF72756 53LF72774 53LF72776 53LF72776 53LT78170 53LT78292 53LF72084 53LF72233 53LF72240 53LF72337 53LF72520 53LF72809 53FG08607 53FG08607 53FG08608 53LT78030 53LF72501 53LF72633 53LF72635 53FG08601 53LF72084 53LF72372 53LF72633 53LF72787 53LT78049 53LT78050 53LF72276 53LF72289 53LF72750 53LF72775 53LF72093 53LF72757 53LF72241. 53LF72501.
RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD.
REASON Platelets, collected on an instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 125 units.
DISTRIBUTION MD and D.C.

PRODUCT Human Tissue, CryoVein Saphenous Vein.
CODE Tissue 7968766.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Human tissue, procured from a donor who was involved in HIV/Hepatitis high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FK58831.
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento, CA.
REASON Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells.
CODE Unit numbers: FK46882 and H63449.
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento, CA.
REASON Blood products, collected from ineligible donors due to decreased hematocrit values, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit number ST228090.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Antonio, TX.
REASON Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of post donation information from the donor related to recent ear piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 7800029.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 1246324.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 12810-9428.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CO, and Switzerland.

PRODUCT Fresh Frozen Plasma.
CODE Unit number L95508.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, untested for antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Recovered Plasma.
CODE Unit number: 113384590.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION TX, NM, and Switzerland.

PRODUCT
Blood products, collected between May 2001 and April 2003, of the following types:
a) Whole Blood.
b) Whole Blood, Leukocytes Reduced.
c) Red Blood Cells.
d) Red Blood Cells (Apheresis).
e) Red Blood Cells, Irradiated.
f) Red Blood Cells, Leukocytes Reduced.
g) Red Blood Cells, Leukocytes Reduced Irradiated.
h) Red Blood Cells, Washed.
i) Red Blood Cells, Deglycerolized.
j) Red Blood Cells, Frozen.
k) Fresh Frozen Plasma.
l) Fresh Frozen Plasma (Apheresis).
m) Recovered Plasma.
n) Platelets.
o) Platelets, Irradiated.
p) Platelets Pheresis.
q) Platelets Pheresis, Irradiated.
r) Platelets Pheresis, Leukocytes Reduced.
s) Platelets Pheresis, Leukocytes Reduced Irradiated.
t) Buffy Coat. (6 units)
u) Cryoprecipitated AHF.
v) Platelets, for Further Manufacturing Use.
CODE Blood products, collected between May 2001 and April 2003, of the above types.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA.
REASON Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16,106 units.
DISTRIBUTION LA, FL, CA, WA, UT, MS, NJ, VA, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
a) Unit numbers 5910810, 5911642, 5911017, 5911647, 5911012, 5750808, 5910124, 5910117, 5750807, 5910803,
5910804, 5910809, 5910108, 5910114, 5910120, 5910125, 5910807, 5910896, 5910897, and 5911652;
b) Unit number 5910811.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL.
REASON Blood products, that were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION FL and NC.

PRODUCT Recovered Plasma.
CODE Unit number 12810-9428.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CO, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers: FC95154 and FC93477.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

WEEK ENDING JUNE 12

PRODUCT Source Plasma.
CODE Unit numbers: 0510314956, 0510314522, 0510314124, 0510313651, 0510313287, 0510312873, 0510312553, 0510312230, 0510311848, 0510311399, 0510310968, 0510303380, 0510303008, 0510301661, 0510301262, 0510300878, 0510300348, and 0510299501.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Nashville, TN.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that did not have the routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF
CODE a), and b) Unit 5628193.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Recovered Plasma.
CODE Unit 5628193.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
c) Red Blood Cells Irradiated.
d) Red Blood Cells Leukocytes Reduced Irradiated.
e) Platelets.
f) Platelets Pheresis.
g) Platelets Pheresis Leukocytes Reduced.
h) Fresh Frozen Plasma.
i) Plasma Frozen Cryoprecipitated Removed.
j) Cryoprecipitated AHF.
k) Granulocytes.
l) Recovered Plasma.
CODE Blood products, which were collected between May 2001 and March 2002, of the above types.
RECALLING FIRM/MANUFACTURER Lifeshare, Inc., Elyia, OH.
REASON Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7,690.
DISTRIBUTION Nationwide.

WEEK ENDING JUNE 19

PRODUCT Recovered Plasma.
CODE Unit number 9030179.
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH.
REASON Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 4133093.
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit KE36183.
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation, dba BloodSource Sacramento, Sacramento, CA.
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 NY.

PRODUCT Source Plasma.

CODE Unit numbers: GR050583, and GR050572.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Grand Rapids, MI.
REASON Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION England.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 40FH26662, 40GV40046.
RECALLING FIRM/MANUFACTURER American Red Cross, Heart of America, Peoria, IL.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 20GM77591.
RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: American Red Cross Blood Services, Great Falls, MT.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 20FJ03216.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, ID.

Manufacturer: American Red Cross Blood Services, Lewiston, ID.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice from mononucleosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ID, and Switzerland.

PRODUCT Whole Blood.
CODE Unit 71J04256-4.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Inc., Ocala, Florida.
REASON Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 2074783.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
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 2 units.
DISTRIBUTION KY.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 042FT45500.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Cryoprecipitated AH.
CODE Unit number: 24KM84198.
RECALLING FIRM/MANUFACTURER American Red Cross, River Valley Region, Louisville, KY.
REASON Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 33GV38645.
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, corresponding to red cells that were possibly contaminated with Pseudomonas aeruginosa and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 33GT43854.
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, corresponding to a unit of Platelets that was pooled and was possibly contaminated with Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT Source Plasma.
CODE DSKJPQ, DSHYTM, DSHXZR, DSHXCF.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturing Firm: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit numbers: GR050422, GR050473, GR050469, GR050506, GR050525, GR050541.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Grand Rapids, MI.
REASON Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION England.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 20LF51252.  
RECALLING FIRM/MANUFACTURER American Red Cross, Lewis and Clark Region, Boise, ID.
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 ID, and Switzerland.

PRODUCT Source Plasma.

CODE Unit number DSNTCZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSNZVC.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSHYRF.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSJQRQ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSMBTN.
RECALLING FIRM/MANUFACTURER International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor in which there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSKZDP.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSNJVT.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number DSPLBT.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

WEEK ENDING JUNE 26

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE
a) Units: 29GL69199, 29GP76599, 29GV55112, 29GW40655, 29GW41130, 29GX82435, 29GY23438, 29GY23439, 29GY23685, 29KC55640, 29KC55645, 29KC56997, 29KE37537;
b) Units: 29GL69199, 29GP76599, 29GW40655, 29GX82435, 29GY23438, 29GY23439, 29GY23685, 29KC55640, 29KC55645, 29KC56997, 29KE37537.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, collected in a manner that may have compromised sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION NC, VA, CA, and Switzerland.

PRODUCT
a) Platelets Pheresis.
b) Platelets Pheresis, Leukocytes Reduced.
c) Platelets Pheresis, Irradiated.
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit numbers: 31132-7918 (2 units), 31132-8819 (2 units), 31132-9070 (2 units), 31133-0253 (2 units),
31133-0319, 31133-0547 (2 units), 31133-0600 (2 units), 31133-1635 (2 units), 31133-1672 (2 units), 31133-1769
(2 units), 31133-1779 (2 units), 31133-2252 (2 units), 31133-2387 (2 units), 31133-3096 (2 units), 31133-4034
(2 units), 31133-4185 (2 units), 31133-4426 (2 units), 31133-4515 (2 units), 31133-5281 (2 units), 31133-5336
(2 units), 31132-1504, 31123-6156, 31123-6612, 31123-6668, 31123-6711, 31123-6721, 31123-8473, 31123-8543,
31123-8555, 31123-8577, 31123-8581, 31123-9001, 31123-9125, 31123-9159, 31123-9161, 31124-0245, 31124-0281,
31124-0296, 31124-0324, 31124-0342, 31124-0809, 31124-0890, 31124-0907, 31124-0950, 31124-0960, 31124-1689,
31124-2611, 31124-2628, 31124-2635, 31124-2658, 31124-2778, 31124-3543, 31124-3576, 31124-4286, 31124-4321,
31124-5216, 31124-5217, 31124-5334, 31124-5343, 31124-5368, 31124, 6491, 31124-6513, 31124-6586, 31124-6584,
31124-7402, 31124-7480, 31124-7543, 31124-7544, 31124-7545, 31124-7560, 31124-7592, 31124-8823,
31124-8869, 31124-8888, 31124-8897, 31124-9447, 31124- 9466, 31124-9493, 31125-0021, 31125-0136, 31125-0161,
31125-0164, 31125-0526, 31125-0527, 31125-0569, 31125-1212, 31125-1315, 31125-1371, 31125-2427, 31125-2462,
31125-2488, 31125-2511, 31125-2539, 31125-3226, 31125-3252, 31125-3276, 31125-3347, 31125-4222, 31125-4249,
31125-4280, 31125-4288, 31125-4353, 31125-4370, 31125-5227, 31125-5229, 31125-5260, 31125-5342, 31125-6647,
31125-6768, 31125-6786, 31125-7812, 31125-7835, 31125-7962, 31125-7963, 31125-7974, 31125-8952, 31125-8967,
31125-8998, 31125-9434, 31125-9446, 31125-9498, 31125-9520, 31125-9528, 31125-9549, 31126-0664, 31126-0768, 31126-1473, 31126-1487, 31126-1546, 31126-1547, 31126-1549, 31126-2351, 31126-2372, 31126-2378, 31126-3480, 31126-3497, 31126-3534, 31126-3573, 31126-4220, 31126-4258, 31126-4272, 31126-4291, 31126-4654, 31126-4760, 31126-5842, 31126-5961, 31126-5993, 31126-7934, 31126-9173, 31126-9182, 31127-0290, 31127-0325, 31127-0354, 31127-0836, 31127-0844, 31127-0892, 31127-0898, 31127-0910, 31127-2205, 31127-2224, 31127-2626, 31127-2657, 31127-2712, 31127-3288, 31127-3333, 31127-3334, 31127-3345, 31127-3362, 31127-3397, 31127-4331, 31127-4354, 31127-4380, 31127-4394, 31127-5047, 31127-5074, 31127-5077, 31127-5102, 31127-5158, 31127-5179, 31127-6222, 31127-6232, 31127-6258, 31127-6293, 31127-6329, 31127-6356, 31127-6358, 31127-7201, 31127-7221, 31127-7269, 31127-7324, 31127-7362, 31127-7367, 31127-7379, 31127-7392, 31127-7400, 31127-7463, 31127-8900, 31127-8907, 31127-8909, 31127-8912, 31127-8928, 31127-8945, 31127-9869, 31127-9870, 31127-9886, 31127-9889, 31127-9894, 31127-9909, 31127-9994, 31128-1042, 31128-1047, 31128-1051, 31128-1059, 31128-1087, 31128-1116, 31128-2009, 31128-2039, 31128-2147, 31128-2178, 31128-2188, 31128-3005, 31128-3008, 31128-3037, 31128-3074, 31128-3084, 31128-3089, 31128-3093, 31128-3108, 31128-3151, 31128-3179, 31128-3964, 31128-4247, 31128-4340, 31128-4358, 31128-5276, 31128-5356, 31128-5382, 31128-5390, 31128-5397, 31128-6124, 31128-6132, 31128-6727, 31128-6798, 31128-7521, 31128-7524, 31128-7525, 31128-7565, 31128-7586, 31128-8319, 31128-8350, 31128-9022, 31128-9093, 31128-9135, 31128-9143, 31129-0237, 31129-0260, 31129-0296, 31129-0382, 31129-1435, 31129-1447, 31129-1492, 31129-1534, 31129-1540, 31129-1542, 31129-2625, 31129-2649, 31129-2740, 31129-2746, 31129-2785, 31129-3430, 31129-3433, 31129-3525, 31129-3529, 31129-3530, 31129-4232, 31129-4288, 31129-4377, 31129-4607, 31129-5022, 31129-5060, 31129-5175, 31129-5501, 31129-5526, 31129-6022, 31129-6023, 31129-6052, 31129-6123, 31129-6147, 31129-6161, 31129-6230, 31129-6241, 31129-6268, 31129-6816, 31129-6979, 31129-6993, 31129-6999, 31129-8249, 31129-8296, 31129-8302, 31129-9251, 31129-9305, 31129-9827, 31129-9840, 31129-9899, 31129-9911, 31129-9921, 31129-9992, 31129-9998, 31130-0804, 31130-0831, 31130-0944, 31130-1146, 31130-2003, 31130-2129, 31130-2132, 31130-2175, 31130-2679, 31130-2680, 31130-2769, 31130-3631, 31130-3635, 31130-3637, 31130-3684, 31130-3752, 31130-4112, 31130-4131, 31130-4806, 31130-4865, 31130-5404, 31130-5432, 31130-5438, 31130-5491, 31130-5820, 31130-5840, 31130-5882, 31130-5950, 31130-6472, 31130-6473, 31130-6580, 31130-7018, 31130-7041, 31130-7063, 31130-7122, 31130-7460, 31130-7476, 31130-7496, 31130-7524, 31130-7549, 31130-8224, 31130-8319, 31130-8350, 31130-8361, 31130-8391, 31130-8868, 31130-8990, 31130-8996, 31130-9803, 31130-9827, 31130-9948, 31130-9951, 31131-0003, 31131-0021, 31131-0072, 31131-0115, 31131-0163, 31131-1030, 31131-3402, 31131-3462, 31131-3471, 31131-3581, 31131-4447, 31131-4500, 31131-4509, 31131-4521, 31131-5603, 31131-5626, 31131-5639, 31131-5648, 31131-5727, 31131-5739, 31131-5772, 31131-6004, 31131-6081, 31131-6122, 31131-6148, 31131-6169, 31131-6192, 31131-6199, 31131-7080, 31131-7083, 31131-7122, 31131-7853, 31131-7879, 31131-8046, 31131-8052, 31131-8064, 31131-8616, 31131-8645, 31131-8761, 31131-9538, 31131-9565, 31132-0027, 31132-0071, 31132-0124, 31124-0174, 31132-0901, 31132-0914, 31132-0955, 31132-0967, 31132-0979, 31132-1409, 31132-1522, 31132-1540, 31132-2046, 31132-3236, 31132-3266, 31132-3337, 31132-4115, 31132-4447, 31132-5427, 31132-5448, 31132-5518, 31132-5585, 31132-6220, 31132-6244, 31132-6257, 31132-7202, 31132-7258, 31132-7903, 31132-8917, 31132-9087, 31133-0236, 31133-0251, 31133-0369, 31133-0422, 31133-0475, 31133-0497, 31133-0610, 31133-0696, 31133-1626, 31133-1664, 31133-2352, 31133-2388, 31133-3004, 31133-3011, 31133-3022, 31133-3037, 31133-4088, 31133-4546, 31133-5261, 31128-2169, 31132-5591, 31123-6758-01, 31123-6758-02, 31123-9051-01, 31123-9051-02, 31124-1786-01, 31124-1786-02, 31124-3448-01, 31124-3575-01, 31124-3575-02, 31124-4303-01, 31124-6553-01, 31124-6553-02, 31124-7542-01, 31124-7542-02, 31124-7546-01, 31124-7546-02, 31124-7572-01, 31124-6553-02, 31124-8976-01, 31124-7542-02, 31124-9518-01, 31124-9518-02, 31125-0570-01, 31125-0570-01, 31125-0570-02, 31125-1382-01, 31125-1382-02, 31125-2510-01, 31125-2510-02, 31125-2559-01, 31125-2559-02, 31125-4266-02, 31125-4348-01, 31125-4348-02, 31125-5320-01, 31125-5320-02, 31125-5393-01, 31125-5939-02, 31125-6609, 31125-6632-01, 31125-6632-02, 31125-6751-01, 31125-6751-02, 31125-6785-01, 31125-6785-02, 31125-7913-01, 31125-7913-02, 31125-8815-01, 31125-8815-02, 31125-8950-01, 31125-8950-02, 31125-9403-01, 31126-0700-01, 31126-0700-02, 31126-1097, 31126-1449-01, 31126-1449-02, 31126-1453-01, 31126-1453-02, 31126-2394-01, 31126-2394-02, 31126-3557-01, 31126-3557-02, 31126-3596-01, 31126-3596-02, 31126-4383-01, 31126-4383-02, 31126-4709-01, 31126-4709-02, 31126-4787-01, 31126-4787-02, 31126-4963-01, 31126-4963-02, 31126-5809-01, 31126-5809-02, 31126-6801, 31126-6977-02, 31126-7808-01, 31126-7828-02, 31126-7838-01, 31126-7838-02, 31126-7855-01, 31126-7855-02, 31126-7879-01, 31126-7879-02, 31126-7953-01, 31126-7953-02, 31126-9072-01, 31126-9106-01, 31126-9106-02, 31126-9182, 31127-0354, 31127-0844, 31127-0898, 31127-0910, 31127-2205, 31127-2224, 31127-2717, 31127-3288, 31127-3362, 31127-3397, 31127-4354, 31127-5047, 31127-5158, 31127-6222, 31127-6232, 31127-6258, 31127-6293, 31127-6329, 31127-6358, 31127-7201, 31127-7362, 31127-7367, 31127-7379, 31127-7400, 31127-8900, 31127-8909, 31127-8928, 31127-8945, 31127-9197, 31127-9870, 31127-9886, 31127-9894, 31127-9994, 31128-1047, 31128-1051, 31128-1059, 31128-1087, 31128-1116, 31128-2175, 31128-2178, 31128-2188, 31128-3005, 31128-3008, 31128-3034, 31128-3074, 31128-3084, 31128-3089, 31128-3093, 31128-3108, 31128-3167, 31128-3179, 31128-4247, 31128-5250, 31128-5356, 31128-5382, 31128-5390, 31128-5397, 31128-6124, 31128-6132, 31128-6798, 31128-7521, 31128-7524, 31128-7525, 31128-7565, 31128-7586, 31128-8319, 31128-9093, 31128-9135, 31128-9143, 31129-0237, 31129-0260, 31129-0296, 31129-0382, 31129-1435, 31129-1492, 31129-1534, 31129-2649, 31129-2740, 31129-2746, 31129-3529, 31129-3530, 31129-4232, 31129-4288, 31129-4607, 31129-5022, 31129-5175, 31129-6052, 31129-6055, 31129-6161, 31129-6230, 31129-6241, 31129-6816, 31129-6993, 31129-8249, 31129-8302, 31129-9251, 31129-9305, 31129-9827, 31129-9840, 31129-9868, 31129-9899, 31130-0804, 31130-0831, 31130-0944, 31130-2003, 31130-2132, 31130-2175, 31130-2679, 31130-2769, 31130-3631, 31130-3635, 31130-3637, 31130-3684, 31130-4079, 31130-4112, 31130-4131, 31130-4865, 31130-5404, 31130-5432, 31130-5820, 31130-5882, 31130-6472, 31130-6580, 31130-7211, 31130-7476, 31130-7496, 31130-7524, 31130-8319, 31130-8350, 31130-8361, 31130-8990, 31130-8996, 31131-0072, 31131-0163, 31131-3402, 31131-3462, 31131-3581, 31131-5639, 31131-6004, 31131-6008, 31131-6081, 31131-6169, 31131-6192, 31131-6199, 31131-7122, 31131-7853, 31131-7879, 31131-7985, 31131-8052, 31131-8616, 31132-0027, 31132-0124, 31132-0174, 31132-1409, 31132-1438, 31132-1522, 31132-2046, 31132-3246, 31132-3266, 31132-5448, 31132-6244, 31132-7202, 31132-7903;        
b) Unit numbers: 31119-7457, 31119-7506, 31119-7513, 31119-7595, 31119-8620, 31119-8657, 31119-8726, 31119-8771, 31119-8774, 31119-9871, 31120-0425-01, 31120-0425-02, 31120-0507, 31120-0510, 31120-0528, 31120-0549, 31120-0597, 31120-1252, 31120-1276, 31120-1279, 31120-1317, 31120-1344, 31120-1375, 31120-2225, 31120-2310, 31120-2389, 31120-3027, 31120-3051-01, 31120-3051-02, 31120-3098-01, 31120-3098-02, 31120-3192, 31120-3200, 31120-4340, 31120-5216, 31120-5353, 31120-6143, 31120-6195, 61120-6610, 61120-6643, 31120-6679, 31120-6775-01, 31120-6775-02, 31120-7078, 31120-7135, 31120-7696, 31120-7768, 31120-7771, 31120-7800, 31120-8673, 31120-8701-01, 31120-8701-02, 31121-0801, 31121-0884-01, 31121-0884-02, 31121-0919, 31121-0934-01, 31121-0934-02, 31121-0938, 31121-0975, 31121-0983-01, 31121-0983-02, 31121-1522-01, 31121-1522-02, 31121-1531-01, 31121-1531-02, 31121-1550, 31121-1572, 31121-1593-01, 31121-1593-02, 31121-2438, 31121-2465, 31121-2519-01, 31121-2519-02, 31121-2532-01, 31121-2532-02, 31121-2560, 31121-2592, 31121-3424, 31121-3452, 31121-3501, 31121-3516, 31121-3552, 31121-3562, 31121-3569-01, 31121-3569-02, 31121-3584, 21121-4453-01, 21121-4453-02, 31121-4488-01, 31121-4488-02, 31121-4517, 31121-4570, 31121-5033, 31121-5159, 31121-5807, 31121-5874, 31121-5942, 31121-5957, 31121-6812, 31121-6996, 31121-7046, 31121-7179, 31121-8240, 31121-8342, 31121-8385, 31121-9349, 31121-9829, 31121-9929, 31121-9953, 31122-0440, 31122-0506, 31122-0590, 31122-1339, 31122-1367, 31122-1388, 31122-1947, 31122-2102-01, 31122-2102-02, 31122-3606, 31122-3738, 31122-3739, 31122-4673-01, 31122-4673-02, 31122-4688, 31122-6400, 31122-6808, 31122-6870, 31122-7442, 31122-7496, 31122-8761, 31122-9391, 31123-0327, 31123-0378, 31123-1030, 31123-1031, 31123-1094-01, 31123-1094-02, 31123-1131, 31123-1163, 31123-1182, 31123-1192-01, 31123-1192-02, 31123-2007, 31123-2070, 31123-2112-01, 31123-2112-02, 31123-2910, 31123-2945-01, 31123-294502, 31123-3832-01, 31123-3832-02, 31123-3884, 31123-3906, 31123-3968, 31123-3991, 31123-3992, 31123-5201, 31123-5210, 31123-5352, 31123-5372, 31123-6056, 31124-0924-01, 31124-0924-02, 31125-0128, 31125-0572, 31125-1226-01, 31125-1226-02, 31125-1347, 31125-3255, 31125-4297-01, 31125-4297-02, 31125-4350-01, 31125-4350-02, 31126-3436, 31126-4748-01, 31126-4748-02, 31127-0311, 31126-7258, 31127-0311, 31127-7258, 31127-8883;
c) Unit numbers: 31124-1604, 31119-9890, 31121-4433-01, 31121-4433-02, 31121-7018;
d) Unit numbers: 31123-6125-01, 31123-6125-02, 31124-4303, 61126-6801, 31124-1772, 31124-3525, 31124-4369, 31129-9868, 31132-2139.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 921 units.
DISTRIBUTION Nationwide.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 6014589.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Newark, DE.
REASON Blood product, collected from a donor who was taking the medication, Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION DE.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number: 3012601.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, collected from a donor who was taking the medication, Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT Source Plasma.
CODE Unit numbers: 528484, 529357, 529583, 533674, and 587296.
RECALLING FIRM/MANUFACTURER

Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturing Firm: International BioResources, LLC, Monroe, LA.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC, and IL.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit FG82764.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Rhode Island Blood Center, Providence, RI.
REASON Blood product, corresponding to red cells that were implicated in a transfusion reaction and were possibly contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number: 9160291.
RECALLING FIRM/MANUFACTURER Vermont Blood Center, Williston, VT.
REASON Blood products, collected from a donor with a history of Addisonís disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Removed.
CODE a) and b) Unit number: LE62765.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
REASON Blood products, in which the corresponding blood component was possibly contaminated with Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION RI, and MA.

PRODUCT Platelets.
CODE Unit numbers: 2064559, 2064575.    
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood products, manufactured from units of whole blood that were collected from donors who had ingested aspirin-like medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Units 004KF69927, 004KF72652;
b) Unit 004KF66468.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA, NH, and VT,

PRODUCT Platelets, Pheresis, Leukocytes Removed.
CODE Unit 004GS10797.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England Region,
Dedham, MA.
REASON Platelets, were inappropriately distributed in one platelet bag instead of two.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE
Units: 042KW16118 042KW16119 042KW16120 042KW16161 042KW16365 042KW16421 042KW16422 042KW16429 042KW16244 042KW16281 042KW16295 042KW16237 042KW16241 042KW16249 042KW16313 042KW16315 042KW16264 042KW16305 042KW16061 042KW16166 042KW16349 042KW16375 042KW16394 042KW16334 042KW16336 042KW16049 042KW16068 042KW16154 042KW16395 042KW16478 042KW16192 042KW16195 042KW16205 042KW16232 042KW16233 042KW16256 042KW16069 042KW16075 042KW16079 042KW16084 042KW16128 042KW16128 042KW16166 042KW16377 042KW16381 042KW16414 042KW16430 042KW16431 042KW16467 042KW16481 042KW16482 042KW16071 042KW16072 042KW16168 042KW16302 042KW16190 042KW16196 042KW16200 042KW16198 042KW16198 042KW16233 042KW16247 042KW16247 042KW16302 042KW16303 042KW16313 042KW16318 042KW16081 042KW16082 042KW16084 042KW16087 042KW16116 042KW16116 042KW16119 042KW16123 042KW16126 042KW16156 042KW16152 042KW16158 042KW16159 042KW16160 042KW16362 042KW16366 042KW16405 042KW16408 042KW16434 042KW16438 042KW16441 042KW16446 042KW16207 042KW16047 042KW16075 042KW16120 042KW16156 042KW16209 042KW16257 042KW16260 042KW16041 042KW16087 042KW16138 042KW16152 042KW16264 042KW16287 042KW16238 042KW16281 042KW16288 042KW16295 042KW16049 042KW16056 042KW16353 042KW16491 042KW16189 042KW16203 042KW16251 042KW16260 042KW16280 042KW16305 042KW16323 042KW16336 042KW16045 042KW16063 042KW16064 042KW16065 042KW16072 042KW16078 042KW16106 042KW16121 042KW16123 042KW16126 042KW16157 042KW16154 042KW16129 042KW16181 042KW16356 042KW16363 042KW16391 042KW16402 042KW16402 042KW16407 042KW16412 042KW16440 042KW16442 042KW16446 042KW16460 042KW16460 042KW16487 042KW16491 042KW16139 042KW16145 042KW16368 042KW16417 042KW16250 042KW16065 042KW16067 042KW16383 042KW16385 042KW16403 042KW16195 042KW16206 042KW16243 042KW16270 042KW16318 042KW16321 042KW16045 042KW16159 042KW16178 042KW16363 042KW16421 042KW16471 042KW16474 042KW16479 042KW16484 042KW16485 042KW16397 042KW16206 042KW16254 042KW16201 042KW16310 042KW16335 042KW16339 042KW16137 042KW16368 042KW16484 042KW16485 042KW16235 042KW16271 042KW16294 042KW16308 042KW16317 042KW16073 042KW16107 042KW16107 042KW16145 042KW16131 042KW16163 042KW16172 042KW16172 042KW16174 042KW16373 042KW16431 042KW16082 042KW16425 042KW16109 042KW16387 042KW16194 042KW16057 042KW16350 042KW16412 042KW16271 042KW16400 042KW16400 042KW16189 042KW16204 042KW16205 042KW16232 042KW16243 042KW16249 042KW16254 042KW16261 042KW16274 042KW16291 042KW16310 042KW16322 042KW16331 042KW16342 042KW16054 042KW16054 042KW16056 042KW16073 042KW16085 042KW16112 042KW16112 042KW16113 042KW16114 042KW16150 042KW16133 042KW16133 042KW16162 042KW16167 042KW16176 042KW16180 042KW16350 042KW16351 042KW16353 042KW16356 042KW16358 042KW16366 042KW16371 042KW16372 042KW16397 042KW16405 042KW16407 042KW16411 042KW16419 042KW16425 042KW16479 042KW16482 042KW16489 042KW16197 042KW16299 042KW16071 042KW16134 042KW16390 042KW16221 042KW16259 042KW16303 042KW16320 042KW16058 042KW16129 042KW16162 042KW16167 042KW16173 042KW16177 042KW16358 042KW16375 042KW16379 042KW16381 042KW16385 042KW16387 042KW16389 042KW16391 042KW16408 042KW16415 042KW16472 042KW16218 042KW16434 042KW16427 042KW16438 042KW16194 042KW16223 042KW16229 042KW16238 042KW16256 042KW16273 042KW16286 042KW16298 042KW16298 042KW16325 042KW16330 042KW16330 042KW16339 042KW16042 042KW16043 042KW16052 042KW16076 042KW16078 042KW16106 042KW16108 042KW16109 042KW16137 042KW16146 042KW16130 042KW16131 042KW16158 042KW16161 042KW16175 042KW16177 042KW16186 042KW16188 042KW16188 042KW16345 042KW16351 042KW16395 042KW16417 042KW16309 042KW16320 042KW16057 042KW16067 042KW16085 042KW16355 042KW16424 042KW16432 042KW16461 042KW16461 042KW16469 042KW16228 042KW16252 042KW16273 042KW16274 042KW16299 042KW16322 042KW16335 042KW16173 042KW16389 042KW16390 042KW16414 042KW16430 042KW16439 042KW16471.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH.
REASON Platelets, collected using an apheresis instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 349 units.
DISTRIBUTION OH, and MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.

CODE a) and b) Units 004H23182, 004N18918.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA.
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, MA, and NY.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Units 24KE48643, 24KJ71315.
RECALLING FIRM/MANUFACTURER American National Red Cross, River Valley Region, Louisville, KY.
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, IL, and KY.

PRODUCT Red Blood Cells Pheresis.
CODE Units 13FV27924 and 13 FV28086.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI.
REASON Blood products, which were determined to have low actual RBC volume resulting in the failure to meet acceptable quality control criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 02LG24761.
RECALLING FIRM/MANUFACTURER American Red Cross, Central Plains Region, Wichita, KS.
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 KS.

PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated.
b) Recovered Plasma.
CODE
a) Units 004J54932 and 004L54784;
b) Unit 004L54784.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA.
REASON Blood products, which were collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA and CA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 36P58864.
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC.
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 02FJ89793.
RECALLING FIRM/MANUFACTURER American Red Cross, Central Plains Region, Wichita, KS.
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 CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 02LC08572, 02FC97190.      
RECALLING FIRM/MANUFACTURER American Red Cross, Central Plains Region, Wichita, KS.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KS and CA.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Cryoprecipitated AHF.
CODE a) and b) Unit FK90502.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc. Providence, RI.
REASON Blood products, which tested negative for the antibody to the human t-lymphotropic virus type I (anti-HTLV-I) but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-I, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and NY.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 02FE08982.
RECALLING FIRM/MANUFACTURER American Red Cross, Central Plains Region, Wichita, KS.
REASON Blood products, collected from an unsuitable donor based on a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KS and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 12LN26128.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Carolinas Region, Winston-Salem.
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 NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 02FZ12897, 02FZ12209.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Wichita, KS.
Manufacturing Firm: American National Red Cross, Central Plains Region, Hays, KS.

REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and KS.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 02FJ90559, 02LG27677.
RECALLING FIRM/MANUFACTURER American National Red Cross, Central Plains Region, Wichita, KS.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KS.

PRODUCT Recovered Plasma.
CODE Unit 11GN56565.
RECALLING FIRM/MANUFACTURER American National Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON Blood product, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Fresh Frozen Plasma. .
CODE Unit number: 24FH35934.
RECALLING FIRM/MANUFACTURER American Red Cross, River Valley Region, Louisville, KY.
REASON Blood product, collected using equipment that had not been validated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Source Plasma.
CODE Unit 527582.
RECALLING FIRM/MANUFACTURER International BioResources, LLC., Monroe, LA.
REASON Blood product, which was collected from a donor who had an unexplained weight loss, was collected.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit 528431.
RECALLING FIRM/MANUFACTURER International BioResources, LLC., Monroe, LA.
REASON Blood product, which was collected from a donor who had an unexplained weight loss, was collected.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units 535402 and 535770.
RECALLING FIRM/MANUFACTURER International Bio Resources, LLC., Monroe, LA.
REASON Blood product, which was collected from a donor who had an unexplained weight loss, was collected.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit W045003011051.
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO.
REASON Blood product, collected from a donor who was taking Dexamethasone at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.

PRODUCT Red Blood Cells.
CODE Unit 4634060.
RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Hospital, Great Lakes, IL.
REASON Red Blood Cells, which tested positive for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Units 1537595-parts 1&2.
RECALLING FIRM/MANUFACTURER Florida Georgia Blood Alliance, Jacksonville, FL.
REASON Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 11FE90803.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO.
REASON Blood products, which tested negative for the antibody for the human immunodeficiency virus (anti-HIV) but were collected from a donor who had previously tested positive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MO and CA.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) Units S39303, S35827;
b) Unit S35827.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
REASON Blood products, collected from a donor taking Nitrofurantoin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 38FV13753.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Plasma, Cryoprecipitate Reduced.
CODE Unit number 18FW47910.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, associated with an unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit 11C54266.
RECALLING FIRM/MANUFACTURER American National Red Cross, Missouri-Illinois Region, St. Louis, MO,
REASON Blood products, collected from a donor who engaged in high risk behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and Switzerland.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 2052278-split 1.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.

REASON Platelets, in which the corresponding Platelets tested positive for the presence of Lactobacillus bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit numbers: 18GJ84736, 18GK34397, 18GH98299, 18GH98298, 18FZ43315, 18FQ93859, 18FZ43266, 18FV57584, 18GH98207, 18GH97519, 18GG64092, 18GH98312.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, mislabeled with the incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Removed, Irradiated.
CODE Unit numbers: 93Y03240, 93Y03242, and 93Y03261.         
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood products, labeled with the incorrect expiration date, were distributed.          
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA.

PRODUCT Source Plasma.
CODE Unit number: DSKPLS.
RECALLING FIRM/MANUFACTURER

Recalling Firm: International Bio Resources, LLC, Scottsdale, AZ.
Manufacturing Firm: International Bio Resources, LLC, Tuscaloosa, AL.
REASON Blood product, collected from a donor whose arm inspection was not performed, was distributed.     
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.    
CODE Unit numbers: DSPLPV, DSNFJS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Bio Resources, LLC, Scottsdale, AZ.
Manufacturing Firm: International Bio Resources, LLC, Tuscaloosa, AL.
REASON
Blood products, collected from a donor whose health history screenings were inadequately performed, was distributed.     
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

PRODUCT
a) Fresh Frozen Plasma, Apheresis.
b) Cryoprecipitated AHF.
CODE
a) Unit 24FH32595;
B) 24FC16988.
RECALLING FIRM/MANUFACTURER American National Red Cross, River Valley Region, Louisville, KY.
REASON Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Rejuvenated.
CODE Unit 0642661.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON Blood product, which was not approved for immediate transfusion following rejuvenation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
Human Tissue for Transplantation:
a) CryoVein, Saphenous Vein;
b) CryoGraft, Pulmonary Trunk Patch.
CODE
a) Serial # 8081525;
b) Serial # 8080033.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Human tissue, processed using an expired anti-microbial solution (AMS), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION MO and SC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 04V07558
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood product, collected from an unsuitable donor due to the use of the antibiotic, Keflex, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Platelets.
CODE Unit number: 36K84706.
RECALLING FIRM/MANUFACTURER American Red Cross, South Carolina Region, Columbia, SC.
REASON Blood product, collected from an unsuitable donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SC.

PRODUCT Source Plasma.
CODE Unit 077786.
RECALLING FIRM/MANUFACTURER International Bio Resources, LLC, Monroe, LA.
REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was collected.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit 005947.
RECALLING FIRM/MANUFACTURER International Bio Resources, LLC, Monroe, LA.
REASON Blood product, which was collected from a donor in which the arm inspection was not performed prior to phlebotomy, was collected.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE Units: G83057.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, IL.
REASON Plateletpheresis products, with an unusual odor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.

b) Fresh Frozen Plasma.
CODE a) and b) Unit number LZ16658.
RECALLING FIRM/MANUFACTURER Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH.
REASON Blood products, collected from a donor with a history of Polymyalgia Rheumatica (PMR), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NH.

PRODUCT Red Blood Cells.
CODE Unit number: 2012558.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood product, that may have contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.