NOVEMBER 2009

WEEK ENDING NOVEMBER 21

PRODUCT  Red Blood Cells Leukocytes Reduced Irradiated, 

CODE Unit: 19GY71399
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, 
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 TN

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72K736077
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AL

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W117009173920
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, 
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

PRODUCT  Platelets Pheresis Leukocytes Reduced, Irradiated. 
CODE Unit: W043209003424
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, 
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TN

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W045009012787
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO,
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION MO

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Units: W071209017348 (2 units)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION TN

PRODUCT  Recovered Plasma. 
CODE Units: 4159152, 3998108, 3974071
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, 
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION Austria

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: 4391558
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, 
REASON
Blood product, collected from a donor who received insulin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TX

PRODUCT  Recovered Plasma. 
CODE Unit: Y135982
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Austria

PRODUCT         
1) Red Blood Cells, Leukocytes Reduced. 2) Platelets, Leukocytes Reduced. 
CODE 1) and 2) Unit: 13FC69931
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, 
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MI, TX

PRODUCT  Red Blood Cells (Aphaeresis), Leukocytes Reduced. 
CODE Unit: 13KZ17992 (Part 1 and Part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, 
REASON
Blood products, in which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MI

PRODUCT  Pyrotell Single test Vial (STV) Limulus Amebocyte Lysate(LAL), Sensitivity,125 EU/mL Catalog Number: GS125. 
CODE Lot Numbers: S08511, S07491
RECALLING FIRM/MANUFACTURER
Associates of Cape Cod, Inc., East Falmouth, MA,
REASON
Pyrotell Single Test Vials, mislabeled with lot number and sensitivity, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,790 packs
DISTRIBUTION United Kingdom, Korea

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE Units: 041GM69478 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, 
REASON
Blood products, which did not meet the acceptable product specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION AL

PRODUCT  Source Plasma. 
CODE
Units: 4550017320, 4550017138, 4550017709, 4550021796, 4550020592, 4550020213, 4550020021, 4550019610, 4550019050, 4550018877, 4550018511, 4550018304, 4550017920
RECALLING FIRM/MANUFACTURER
Life Sera, Inc., Columbia, SC,
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION Canada, NC

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 2) Recovered Plasma. 
CODE 1) and 2) Unit: 003FM09942
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION GA

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE
Units: 012GW33331 (Parts 1 & 2), 012GW33337, 012GW33341 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC
REASON
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION NC

PRODUCT  Source Plasma. 
CODE Unit: 09SMNA0333
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Saint Cloud, MN,
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.  
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Austria

PRODUCT  Pheresis Leukocytes Reduced. 
CODE Unit: W270109302094
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, 
REASON
Blood product, which exceeded the maximum criteria for platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION PA

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W0352091552595
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX,
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 TX

PRODUCT  Source Plasma. 
CODE Unit: DU0671583
RECALLING FIRM/MANUFACTURER
DCI Plasma Center of Duluth, LLC, Duluth, MN, 
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 United Kingdom

PRODUCT Recovered Plasma, 
CODE Unit: 19GY71399
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, 
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 CA

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit: W045009055307
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO,
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION MO

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 2) Fresh Frozen Plasma. 
3) Platelets. 
CODE 1), 2) and 3) Unit: W035209133877C
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX,
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION TX

PRODUCT 
1) BOOSTRIX INJ. SUSP., Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, 10 x 0.5ML Disposable Prefilled Tip-Lok" Syringes, NDC #58160-842-11. 

2) Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Rx only, 5 x 0.5ML Disposable Prefilled Tip-Lok" Syringes, For Adolescent Use Only, Rx only, NDC #58160-842-46.

3) CROFAB INJ. 1GM 2VIAL, NDC #0281-0330-10, SAVAGE LABS. 

4) DIGIFAB 40MG, NDC #0281-0365-10, SAVAGE LABS. 

5) ENGERIX-B, HEPATITIS B VACCINE (RECOMBINANT), 10MCG/0.5ML 10X0.5ML Single Dose Vials, Rx only, NDC #58160-820-11. 

6) GARDASIL INJECTION [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 0.5ML Single Dose Vials, Rx only, NDC #0006-4045-00. 

7) GARDASIL INJECTION [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 10X0.5ML Single Dose Vials, Rx only, NDC #0006-4045-41. 

8) GARDASIL INJ. 6X0.5ML PF, NDC #0006-4109-06. 

9) HAVRIX HEPATITIS A VACCINE INACTIVATED INJECTION SOLUTION, 1440ELU/ML 10X1ML, Single Dose Vials, For Adult Use Only, Rx only, NDC #58160-826-11. 

10) HAVRIX HEPATITIS A VACCINE INACTIVATED INJECTION SOLUTION, 1440ELU/ML 5X1ML, Disposable Prefilled Tip-Lok Syringes, For Adult Use Only, Rx only, NDC #58160-826-46. 

11) HAVRIX HEPATITIS A VACCINE INACTIVATED, 720ELU 5X0.5ML, Disposable Prefilled Tip-Lok Syringes, Rx only, For Pediatric/Adolescent Use Only, NDC #58160-825-46. 

12) HEPATITIS B VACCINE ENGERIX B, FOR ADULT USE ONLY 20MCG/ML 5X1, Single dose vials, Rx only, NDC #58160-821-46. 

13) HEPATITIS B VACCINE ENGERIX B, FOR ADULT USE ONLY 20MCG/ML10X1ML, NDC #58160-821-11, Single dose vials, Rx only. 

14) INFANRIX INJECTION, Diphtheria and Tetanus toxoids and Acellular Pertussis Vaccine Adsorbed, 10X0.5ML, Single-Dose Vials, Rx only, NDC #58160-840-11. 

15) KINRIX" INJECTION SUSPENSION (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adorbed and Inactivated Poliovirus Vaccine, 10X0.5ML, Single Dose Vials, Rx only, NDC #58160-812-11. 

16) MERUVAX II (Wistar RA 27/3 Strain), RUBELLA VIRUS VACCINE LIVE, 10 Single Dose Vials, Rx only, NDC #0006-4673-00. 

17) M-M-R II MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE, 0.5MLX10 SINGLE-DOSE VIAL, Rx only, NDC #0006-4681-00. 

18) NABI-HB Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated and Filtered, For Intramuscular Administration Only, 312U/ML 1ML, Rx only, NDC #59730-4202-1. 

19) NABI-HB Hepatitis B Immune Globulin (Human), Solvent/Detergent Treated and Filtered, For Intramuscular Administration Only, 312U/ML 5ML, Rx only, NDC #59730-4203-1. 

20) PEDIARIX SOLUTION INJECTION, [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], 10X0.5ML Single Dose Vials, Rx only, NDC #58160-811-11.

21) PEDIARIX SOLUTION INJECTION, [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], 5X0.5ML DISPOSABLE PREFILLED TIPLOK SYRINGES, Rx only, NDC #58160-811-46. 

22) PNEUMOVAX, 23, Pneumococcal Vaccine Polyvalent, 25MCG 10X0.5ML, NDC #0006-4943-00. 

23) PNEUMOVAX, Pneumococcal Vaccine Polyvalent, For Syringe Use Only, 23 x 5MCG/0.5ML 2.5ML, NDC #0006-4739-00. 

24)  RECOMBIVAX HB, Hepatitis B Vaccine {Recombinant], Adult Formulation, 10MCG/ML 10 Single Dose X 1ML Vials, NDC #0006-4995-41. 

25) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Adult Formulation, 10MCG/ML 1 Dose 1ML Vial, Rx only, NDC #0006-4995-00. 

26) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Adult Formulation, 10MCGML 6 Single Dose X 1ML Syringes, with separate 1 needle, Rx only, NDC #0006-4094-06. 

27) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Dialysis Formulation, 40MCG/ML 1 Dose X 1ML Vial, NDC #0006-4992-00. 

28) RECOMBIVAX HB, Hepatitis B Vaccine [Recombinant], Pediatric/Adolescent, 5MCG/0.5ML10Single Dose 0.5mL Vials, Rx only, NDC #0006-4981-00. 

29) REGRANEX GEL 0.01% (becaplermin), 15GM TUBE (For Topical Use Only, NDC #0045-0810-15. 

30) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG 25, NDC #0562-7805-25. 

31) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG 5, NDC #0562-7805-05. 

32) RHOGAM, RHO (D) IMMUNE GLOBULIN (HUMAN) ULTRA-FILTERED PLUS, 300MCG Dose (1500IU), (For Intramuscular Use Only), Rx only, NDC #0562-7805-01. 

33) ROTATEQ, ROTAVIRUS VACCINE, LIVE, ORAL PENTAVALENT, For Oral Use Only, Not for Injection, 10 Single-Dose X 2M LUD TUBE, Rx only, NDC #0006-4047-41. 

34) TWINRIX, Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine, 20MCG-720ELU/ML, 10 X 1ML Single-Dose Vials, For Adult Use Only, NDC #58160-815-11.

35)  TWINRIX, Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine, 5 Disposable Prefileld Tip-Lok Syringes each containing one 1ML dose, For Adult Use Only, Rx only, NDC #58160-815-46. 

36) VIVOTIF Typhoid Vaccine Live Oral Ty21a (for oral, active immunization against typhoid fever), Rx only, NDC #58337-0003-1. 
CODE
1) Lot Number: AC52B020AA;

2) Lot Numbers: AC52B024DB and AC52B028AA;

3) Lot Number: BN20;

4) Lot Number: BN200874 and BN200788C;

5) Lot Numbers: AHBNB659BA, AHBVB659BA, AHBVB659AA, AHBVB659BA, AHBVB674BA and AHBVB647BA;

6) Lot Numbers: 0546X and 0847X;

7) Lot Numbers: 0843X, 0571X and 0548X;

8) Lot Numbers: 0573X and 0947X;

9) Lot Number: AHAVB252AA;

10) Lot Numbers: AHVAB251CA, AHABV251BA, AHAVB251BA and AHAVB251CA;

11) Lot Numbers: AHAVB280AA, AHAVB284AA, AHAVB284CA, AHAVB284DA, AHAVB289BA, AHAVB289CB, AHAVB291AA, AHAVB291CA, AHAVB292AA, AHAVB268EA, AHAVB268DA, AHAVB264AA, AHAVB320AA, AHAVB297CA, AHAVB319AA, AHAVB309AA, AHAVB320BA, AHAVB624AA, AHAVB297AA, AHAVB289AA and AHAVB294BA;

12) Lot Numbers: AHBVB640BA, AHBVB540BA and AHBVB640AA;

13) Lot Numbers: AHBVB670AA and AHBVB584AA;

14) Lot Numbers: AC14B065AA and AC14B064AA;

15) Lot Numbers: AC20B116AB and AC20B084BB;

16) Lot Number: 1198X;

17) Lot Numbers: 0931X, 0987X, 1080X, 1208X, 1247X and 1250X;

18) Lot Numbers: 908519 and 909304;

19) Lot Numbers: 907749, 906397, 909304;

20) Lot Numbers: AC21B167AA, AC21B150AA and AC21B173AA;

21) Lot Numbers: AC21B198BA, AC21B163BC, AC21B192BA, AC21B192CA, AC21B192DA, AC21B201AA and AC21B198AA;

22) Lot Numbers: 0619X, 0869X, 0612X, 0614X, 021X, 0978X, 0868X, 1295X, 0813X, 0724X, 0725X, 0742X, 0743X, 0551X, 0669X,and 0224X;

23) Lot Numbers:0619X, 0224X, 0619X,1679U, 0867X, 0551X, 0224X and 0868X;  

24) Lot Numbers: 0396X, 0398X, 0838X, 0866X and 0126X;

25) Lot Numbers: 0399X and 0866X;

26) Lot Numbers: 0757U and 1040X;

27) Lot Numbers: 0757U, 1040X, 0866X and 0724X;

28) Lot Numbers: 0026X, 0725X, 0610X, 1719U, 0599X, 0601X, 0401X and 0062X;

29) Lot Numbers: L003 and L004;

30) Lot Numbers: RVP113A1, RVP110A1, RVP112A1, RVP116A1 and RVP115A1;

31)  Lot Number: RVP113A1;

32) Lot Numbers: RVP109A1, RVP110A1, RVP112A1 and RVP116A1;

33) Lot Numbers: 0469X, 0894X, 0502X, 0964X, 0467X and 0594X;

34) Lot Number: AHABB140AA;

35)  Lot Numbers: HABB128AB, AHABB132CC, AHABB132AC and AHABB132AA;

36) Lot Number: 5833700031
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Care, McDonough, GA, 
Manufacturer: Merck & Co, Inc., Whitehouse Station, NJ. 
REASON
Products, whose stability may have been compromised due to defective refrigeration unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION AL, GA, MO, MS, SC, TN and WV

PRODUCT  Source Plasma. 
CODE
Units: 3870017730, 3870016762, 3870016636, 3870078716, 3870069832, 3870069230, 3870068436, 3870066901, 3870026539, 3870026041, 3870018748, 3870067630, 3870018007
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Springfield, IL,
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION Austria

WEEK ENDING NOVEMBER 14

PRODUCT Red Blood Cells, Leukocytes Reduced. 

CODE Unit: 93FK00452

RECALLING FIRM/MANUFACTURER

Cooley Dickinson Hospital, BB, Northampton MA

REASON

Blood product, which tested negative for the antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II), but was collected from a donor who previously tested positive for anti-HTLV-I/II, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION MA

 

PRODUCT Red Blood Cells, Leukocytes Reduced. 

CODE Units: 18GK67224, 18GL68730, 18GL70979

RECALLING FIRM/MANUFACTURER

American National Red Cross Great Lakes Region, Lansing, MI

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION MI

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Platelets Pooled Leukocytes Reduced. 

CODE

1) Unit: W051709106147;

2) Unit: W051709801969

RECALLING FIRM/MANUFACTURER

Rhode Island Blood Center, Providence, RI, 

REASON

Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION RI, MA

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: W117008143411

RECALLING FIRM/MANUFACTURER

Blood Centers of the Pacific, San Francisco, CA, 

REASON

Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION CA

 

PRODUCT Platelets Pheresis, Leukocytes Reduced. 

CODE Unit: 012KH21112

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services, Durham, NC.

REASON

Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

10

DISTRIBUTION NC

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Recovered Plasma. 

CODE

1) and 2) Unit: 5690205

RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida’s Blood Centers, Inc., Ormond Beach, FL

Manufacturer: Florida’s Blood Centers, Inc., Deland, FL. 

REASON

Blood products, collected from a donor with a history of jaundice, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION Austria, FL

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 003GQ11700

RECALLING FIRM/MANUFACTURER

The American National Red Cross – Southern Region, Douglasville, GA,

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 GA

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 42K89666

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Cleveland, OH,

REASON

11

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION OH

 

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 012GM51999

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC

Manufacturer: American Red Cross Blood Services, Asheville, NC. 

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 GA

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 20X28619

RECALLING FIRM/MANUFACTURER

The American National Red Cross, Salt Lake City, UT

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 CA

 

PRODUCT

1) Platelets Leukocytes Reduced. 

2) Red Blood Cells Leukocytes Reduced. 

3) Platelets Leukocytes Reduced Irradiated.

4) Fresh Frozen Plasma.

CODE

1) Unit: 19GY64937;

2) Units: 19GY64937, 19GY68284;

3) Unit: 19GY68284;

4) Units: 19GY64937, 19GY68284

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, 

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

6 units

DISTRIBUTION TN, KY

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Units: 38FV58728, 38FV73467

RECALLING FIRM/MANUFACTURER

American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION IN

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 50E60752

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, 

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 MO

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 2545052

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, 

REASON

Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION KY

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Platelets Leukocytes Reduced.

CODE 1) and 2) Unit: 13FW42748

RECALLING FIRM/MANUFACTURER

American Red Cross, Southeastern Michigan Region, Detroit, MI,

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION MI

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Units: 2495601, 2517992

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, 

REASON

Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION KY

 

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 7531811

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, 

REASON

Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION KY

 

PRODUCT Source Plasma. 

CODE

Units: 365092887; 365080312; 365078372; 65076086; 365072469; 65069292; 365069252

RECALLING FIRM/MANUFACTURER

Telecris Plasma Resources, Roanoke, VA, 

REASON

Blood products, collected from a donor who was permanently deferred for high risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE

7 units

DISTRIBUTION NC

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 004L10739

RECALLING FIRM/MANUFACTURER

ARC Blood Services, New England Region, Dedham, MA,

REASON

Blood product, collected from an unsuitable donor, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION MA

 

PRODUCT Red Blood Cells (Apheresis). 

CODE Unit: 7526418 (Part A)

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, 

REASON

Blood product, which did not meet the minimum requirement for Red Blood Cell volume, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION KY

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Plasma Frozen within 24 hours (FP24). 

CODE

1) and 2) Unit: 36FL34550

RECALLING FIRM/MANUFACTURER

Recalling Firm: American National Red Cross, Columbia, SC, 

Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. 

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION GA, SC

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 01GG28191

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Blood Services, West Henrietta, NY

Manufacturer: American Red Cross Blood Services, Syracuse, NY. 

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

16

1 unit

DISTRIBUTION NY

 

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: 36FM71531 (2 units)

RECALLING FIRM/MANUFACTURER

American National Red Cross, Columbia, SC, 

REASON

Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION SC

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 6190196

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, 

REASON

Blood product, collected from a donor taking the drug Evista, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION TX

 

PRODUCT Buffy Coat. 

CODE Unit: W149509302814

RECALLING FIRM/MANUFACTURER

Northern California Community Blood Bank, Eureka, CA, 

REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION CA

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 012LW35830

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services Carolinas Region, Winston Salem, NC.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION NC

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 012FX23590

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross, Carolinas Blood Services Region, Charlotte, NC,

Manufacturer: American Red Cross Blood Services, Durham, NC. 

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION NC

 

PRODUCT

1) Red Blood Cells (Apheresis) Leukocytes Reduced. 

2) Red Blood Cells Leukocytes Reduced. 

CODE

1) W037909137004 (part 1 and 2);

2) W037909121384

RECALLING FIRM/MANUFACTURER

Blood Center of Iowa, Des Moines, IA

REASON

18

Blood products, which were labeled as FY (-a) and JK(-a), but were subsequently found to be FY (a+) and JK (a+), were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION IA

 

PRODUCT

1) Red Blood Cells. 

2) Recovered Plasma. 

CODE 1) and 2) Unit: L33567

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA,

REASON

Blood products, collected from a donor who was previously deferred, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION Switzerland, WA

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Plasma Frozen within 24 hours (FP24). 

CODE 1) and 2) Unit: 01W47782

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, West Henrietta, NY, 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION NY, PA

 

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced. 

CODE Unit: 01KT40202 (Part 1 and 2)

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, West Henrietta, NY

REASON

Blood products, which did not undergo quality control testing, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION NY

 

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: W036509066845

RECALLING FIRM/MANUFACTURER

LifeShare Blood Centers, Baton Rouge, LA, .

REASON

Blood product, that was not quarantined after receiving information concerning post-donation illness, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION LA

 

PRODUCT

1) Plasma Frozen within 24 hours (FP24). 

2) Red Blood Cells Leukocytes Reduced. 

CODE 1) and 2) Unit: 012FQ89247

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC,

Manufacturer: American Red Cross Blood Services, Durham NC. 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION NC, GA

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 03FJ95107

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, 

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION GA

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Platelets Pooled Leukocytes Reduced. 

CODE 1) and 2) Unit: 033GM65570

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Farmington, CT, 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION CT

 

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Units: 012FQ92207, 012FW35525

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services, Durham NC. 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION SC, NC

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Platelets Leukocytes Reduced.

3) Recovered Plasma. 

CODE 1), 2) and 3) Unit: 42GX10058

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Cleveland, OH,

REASON

Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION OH

 

PRODUCT Red Blood Cells. 

CODE Unit: W141608691220

RECALLING FIRM/MANUFACTURER

Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA

Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. 

REASON

Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION Austria

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Plasma Frozen within 24 hours (FP24). 

CODE 1) and 2) Unit: 012GS89850

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, .

Manufacturer: American Red Cross Blood Services, Durham NC. 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

22

2 units

DISTRIBUTION NC

 

PRODUCT Red Blood Cells. 

CODE Unit: 1290561

RECALLING FIRM/MANUFACTURER

Memorial Blood Centers, Saint Paul, MN, 

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION MN

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced Irradiated. 

2) Fresh Frozen Plasma.

3) Red Blood Cells. 

CODE

1) Unit: G37169;

2) Units: W127808503407, G37169;

3) Units: W127809700976, W127808503407, G32662, E10511

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA, 

REASON

Blood products, collected from a donor who was taking the drug Proscar, were distributed.

VOLUME OF PRODUCT IN COMMERCE

7 units

DISTRIBUTION WA, PA

 

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated. 

CODE Unit: W127808504296

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA, 

REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION WA

 

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced. 

CODE Units: W037909122866 (Part 1 and 2)

RECALLING FIRM/MANUFACTURER

Blood Center of Iowa, Des Moines, IA, 

REASON

Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION IA

 

PRODUCT

1) Platelets Leukocytes Reduced Irradiated. 

2) Platelets Pheresis Leukocytes Reduced. 

CODE

1) Unit: W115909010494;

2) Units: W115909012396, W115909011073 (part 1 and 2), W115908029284

RECALLING FIRM/MANUFACTURER

Central California Blood Center, Fresno, CA, 

REASON

Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION CA

 

PRODUCT

1) Red Blood Cells Leukocytes Reduced. 

2) Platelets Leukocytes Reduced. 

3) Red Blood Cells Leukocytes Reduced Irradiated. ;

4) Red Blood Cells (Apheresis) Leukocytes Reduced. 

CODE

1) Unit: 022FZ67363;

2) Units: 022FQ76103, 022FS80951, 022GC10636, 022GH69205, 022LC65888, 022LC65943, 022LP52492, 022GV28838, 022GV28842, 022GV28857, 022GV28862, 022GV28865;

3) Units: 022FQ76103, 022LC65888;

4) Unit: 022GH68928

RECALLING FIRM/MANUFACTURER

American National Red Cross, Penn Jersey Region, Philadelphia, PA,

REASON

Blood products, which were incorrectly tested for human T lymphotropic virus, types I and II (HTLV-I/II), were distributed.

VOLUME OF PRODUCT IN COMMERCE

16 units

DISTRIBUTION PA, NJ, VA

 

PRODUCT Source Plasma. 

CODE Unit: HP198254

RECALLING FIRM/MANUFACTURER

Interstate Blood Bank Inc. of Chicago, Chicago, IL, 

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 IL

 

PRODUCT Recovered Plasma. 

CODE Units: 18GK67224, 18GL68730, 18GL70979

RECALLING FIRM/MANUFACTURER

American National Red Cross Great Lakes Region, Lansing, MI

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

25

3 units

DISTRIBUTION CA

 

PRODUCT Recovered Plasma.

CODE Unit: W035208195424B

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX,

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 Austria

 

PRODUCT Fresh Frozen Plasma. 

CODE Unit: 003GQ11700

RECALLING FIRM/MANUFACTURER

The American National Red Cross – Southern Region, Douglasville, GA,

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 GA

 

PRODUCT Recovered Plasma, 

CODE Unit: 42K89666

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Cleveland, OH, 

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

26

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION CA

 

PRODUCT Recovered Plasma. 

CODE Unit: 012GM51999

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC,

Manufacturer: American Red Cross Blood Services, Asheville, NC.

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 CA

 

PRODUCT Recovered Plasma. 

CODE Unit: 20X28619

RECALLING FIRM/MANUFACTURER

The American National Red Cross, Salt Lake City, UT,

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 CA

 

PRODUCT Recovered Plasma. 

CODE Units: 38FV58728, 38FV73467

RECALLING FIRM/MANUFACTURER

American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,

REASON

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION CA

 

PRODUCT Recovered Plasma. 

CODE Unit: 50E60752

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, 

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 CA

 

PRODUCT Recovered Plasma. R

CODE Unit: 13FW42748

RECALLING FIRM/MANUFACTURER

American Red Cross, Southeastern Michigan Region, Detroit, MI

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 CA

 

PRODUCT Micro SSP Allele Specific HLA Class I DNA Typing Tray - A*03; Product Number: SSPI-03; Lot Number: 002, batch 002 and 003 Expiration Date: 31 Oct 2010; Product Insert Number: SSP-DNAT-PI-EN Rev 16. Recall # B-0179-10

CODE Lot Number: 002

RECALLING FIRM/MANUFACTURER

One Lambda, Inc., Canoga Park, CA,

REASON

HLA Class I DNA Typing Trays, with incorrect internal control (IC) in well 3D , were distributed.

VOLUME OF PRODUCT IN COMMERCE

17 units

DISTRIBUTION AL, NY, MS, Canada, Germany, Israel, Italy, Japan, Spain, China and Singapore

 

PRODUCT Recovered Plasma.

CODE Unit: 01GG28191

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Blood Services, West Henrietta, NY

Manufacturer: American Red Cross Blood Services, Syracuse, NY. 

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 CA

 

PRODUCT Recovered Plasma. 

CODE Unit: 012LW35830

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services Carolinas Region, Winston Salem, NC

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION NC

 

PRODUCT Recovered Plasma

CODE Unit: 012FX23590

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross, Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services, Durham, NC. 

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION CA

 

PRODUCT Recovered Plasma.

CODE Unit: 03FJ95107

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA,

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION GA

 

PRODUCT Recovered Plasma. 

CODE Unit: 033GM65570

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Farmington, CT, .

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION CT

 

PRODUCT Recovered Plasma. R

CODE Units: 012FQ92207, 012FW35525

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 

Manufacturer: American Red Cross Blood Services, Durham NC. 

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION SC, NC

 

PRODUCT Recovered Plasma. 

CODE Unit: 1290561

RECALLING FIRM/MANUFACTURER

Memorial Blood Centers, Saint Paul, MN, 

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION Switzerland

WEEK ENDING NOVEMBER 7

PRODUCT  Cryoprecipitated AHF. 
CODE Unit: 9862515
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, 
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION TX

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Units: 7373689, 7367377, 7343194, 7333394
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Melbourne, FL, 
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION FL

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Platelets Leukocytes Reduced.
CODE 1) and 2) Unit: 42L48974
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH,
REASON
Blood products, collected from a donor who reported living in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION OH

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 2) Cryoprecipitated AHF. 
CODE 1) and 2) Unit: 004J14656
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MA, ME

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Red Blood Cells. 
3) Plasma Frozen Within 24 Hours After Phlebotomy (FP24).  
CODE
1) Unit: 004LF27246;
2) and 3) Unit: 004Z53797
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION NY, MA

PRODUCT  Source Plasma. 
CODE Unit: 08FOHJ7754
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P, Findlay, OH, 
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Austria

PRODUCT  Source Plasma. 
CODE Recall # 08BMTF3762
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P, Billings, MT, 
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Austria

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Plasma Frozen within 24 hours (FP24). 
CODE 1) and 2) Unit: 012FG24781
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 
Manufacturer: American Red Cross Blood Services, Durham, NC. 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION SC, NC

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 22FS76038
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, 
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION PA

 

PRODUCT 
1) Plasma Frozen Within 24 hours After Phlebotomy (FP24).
2) Red Blood Cells Leukocytes Reduced. CODE
1) and 2) Unit: 22KH39833
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION NJ, PA

 

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Plasma Frozen Within 24 hours After Phlebotomy (FP24). 
CODE 1) and 2) Unit: 004FR40511
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA 
Manufacturer: American Red Cross Blood Services NE Region, Portland, ME. 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION NY, CT

 

PRODUCT  Source Plasma, 
CODE Units: AU0058868, AU0059433, AU0060491, AU0058011
RECALLING FIRM/MANUFACTURER
DCI Biologicals Austin, LLC, Austin, TX, by fax on June 11, 2009. 
REASON
Blood products, collected from a donor who provided post donation information regarding having received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION CA

 

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE Unit: W090709005628
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA,
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION PA

 

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: 032FT19944
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, 
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NY

 

PRODUCT  Red Blood Cells.
CODE Units: 1379867, 1242501
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MN

 

PRODUCT  Source Plasma. 
CODE Unit: 08FING7057
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, 
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

 

PRODUCT  Red Blood Cells (Apheresis) Leukocytes Reduced. 
CODE Units: 6287648 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX,
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION TX

 

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Fresh Frozen Plasma. 
CODE
1) and 2) Unit: 2445685
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, 
REASON
Blood products, collected from a donor considered to be at increased risk for the variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION TX

 

PRODUCT  Platelets. 
CODE
Units: FF52897; FF53017; GM69029; GM69027; GM69024; GM69020; GM69019; GM69018;  GM70380; GM70376; GM70377
RECALLING FIRM/MANUFACTURER
Washington Hospital Center Building Bk, Washington, DC, 
REASON
Blood products, which were not prepared in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION DC, MD

 

PRODUCT  Source Plasma. 
CODE
Units: 365107805; 365107036; 365105148; 365102546; 365102351; 365101734; 365101634; 365086097; 365086072
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, 
Manufacturer: Telecris Plasma Resources, Roanoke, VA. 
REASON
Blood products, collected from a donor who was indefinitely deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION NC

 

PRODUCT  Red Blood Cells. 
CODE Unit: 4252491
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK,
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION FL

 

PRODUCT  Platelets.
CODE Units: 9218043; 9218048; 9218050; 9217894
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, 
REASON
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION MI

 

PRODUCT  Red Blood Cells (Apheresis) Leukocytes Reduced. 
CODE Units: 18GN51993 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, 
REASON
Blood products, collected in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION MI

 

PRODUCT  Red Blood Cells, Leukocytes Reduced. 
CODE Unit: 13FC69921
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, 
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION MI

 

PRODUCT  Red Blood Cells, Leukocytes Reduced. 
CODE Unit: 18GM34303
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI,
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION MI

 

PRODUCT  Source Plasma. 
CODE
Units: GA1144231; GA1144705; GA1145453; GA1146020; GA1146672; GA1147282; GA1147890; GA1148377; GA1149114; GA1149756; GA1150447; GA1150976; GA1152179; GA1155886; GA1156325; GA1157119; GA1157638; GA1158431; GA1158754; GA1159350; GA1159876; GA1160500; GA1161083; GA1161821; GA1163218; GA1164052; GA1164395; GA1167461; GA1168030; GA1169073; GA1169630; GA1176451; GA1177480; GA1177952; GA1178951; GA1179287; GA1180066
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION NY, UK, Austria

PRODUCT  Recovered Plasma. 
CODE Unit: 004J14656
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

PRODUCT  Recovered Plasma. 
CODE Unit: 004LF27246
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, 
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

PRODUCT  Source Plasma, 
CODE Unit: 08MOHF7064
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH,
REASON
Blood product, collected from a donor whose arm inspection was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Austria

PRODUCT  Recovered Plasma. 
CODE Unit: 22FS76038
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

PRODUCT 
1) Fresh Frozen Plasma (Apheresis), 
2) Platelets Pheresis Leukocytes Reduced. CODE
1) Unit: 3728412;
2) Units: 3728412, 3722785
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on June 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using expired apheresis collection kits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION IL

PRODUCT  Recovered Plasma. 
CODE Unit: 032FT19944
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, 
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA

PRODUCT  Source Plasma. 
CODE Unit: 6120132155
RECALLING FIRM/MANUFACTURER
CSI Plasma, Inc., Columbia, SC,
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION Switzerland

PRODUCT  Recovered Plasma. 
CODE Units: 1379867, 1242501
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION Switzerland

PRODUCT  Source Plasma. 
CODE Unit: 365074882
RECALLING FIRM/MANUFACTURER
Telecris Plasma Resources, Roanoke, VA, 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NC

PRODUCT  Red blood cells, leukocytes reduced. 
CODE
Units: 13GF06670, 13GF06671, 13GF06672, 13GF06673, 13GF06674, 13GF06675, 13GF06676, 13GF06677, 13GF06678, 13GF06679, 13GF06681, 13GF06684, 13GF06685, 13GF06686, 13GF06687, 13GF06688, 13GF06689, 13GF06690, 13GF06691, 13GF06692, 13GF06693, 13GF06694, 13GF06695, 13GF06696, 13GF06697, 13GF06698, 13GF06699, 13GF06700, 13GF06701, 13GF06703 and 13GF06704
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI
REASON
Blood products, collected using trip scales for which the daily quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION MI, NB, PR