BIOLOGICS - CLASS II (FDA Recalls and Field Corrections)

PRODUCT

Recovered Plasma. Recall # B-1381-11

CODE

Units: R23959, J06578

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on July 24, 2009. Firm initiated recall is complete.

REASON

Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

Austria

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1545-11

CODE

Unit: # G19011

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on October 27, 2008 and by letter dated February 27, 2009. Firm initiated recall is complete.

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

1) Fresh Frozen Plasma. Recall # B-1612-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1613-11

CODE

1) and 2) Unit: W128708013998

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and facsimile on December 31, 2008 or January 2, 2009. Firm initiated recall is complete.

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

1) Red Blood Cells. Recall # B-1616-11;

2) Fresh Frozen Plasma. Recall # B-1617-11;

3) Red Blood Cells Leukocytes Reduced. Recall # B-1618-11;

4) Recovered Plasma. Recall # B-1619-11

CODE

1) Unit: 1269827;

2) Unit: 8225976;

3) Units: 8208190; 8506204; 8225976; 8247892; 8008477; 8700662;

4) Units: 1269827; 8208190; 8506204; 8247892; 8008477; 8700662

RECALLING FIRM/MANUFACTURER

Houchin Blood Services, Bakersfield, CA, by facsimile on December 16, 2005. Firm initiated recall is complete.

REASON

Blood products, collected from previously deferred donors, were distributed.

VOLUME OF PRODUCT IN COMMERCE

14 units

DISTRIBUTION

CA, NJ and Switzerland

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1621-11

CODE

Unit: W128708016088

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on December 1, 2009. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose health history screening was inadequately performed, was distributed

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA and Austria

___________________________________

PRODUCT

Platelets Pooled Leukocytes Reduced. Recall # B-1629-11

CODE

Unit: W0352110312665

RECALLING FIRM/MANUFACTURER

Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated May 25, 2011. Firm initiated recall is complete.

REASON

Blood product, which was not tested for pH, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1693-11

CODE

Unit: W038510385512

RECALLING FIRM/MANUFACTURER

Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 7 and February 19, 2011. Firm initiated recall is complete.

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

TN

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1697-11

CODE

Units: 017FR94348; 017LG20632

RECALLING FIRM/MANUFACTURER

The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 19, 2011. Firm initiated recall is complete.

REASON

Blood products, phenotyped positive for the Jk(a)antigen but labeled as Jk(a) antigen negative, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

MN

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1729-11

CODE

Units: W128710061831(part 1); W128710061831(part 2)

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated April 2, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA

___________________ ___________________________________

PRODUCT

Source Plasma. Recall # B-1735-11

CODE

Unit: 11MTNA5065

RECALLING FIRM/MANUFACTURER

Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 2, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

 ________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1738-11

CODE

Units: 22FR31863; 22FR32077; 22GZ52069; 22LC82010; 22LC82019

RECALLING FIRM/MANUFACTURER

American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and letter on April 22, 2011. Firm initiated recall is complete.

REASON

Blood products, positive for the E-antigen but labeled as E-antigen negative, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION

PA

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1739-11

CODE

Units: 22FS46558 Part 1; 22FS46558 Part 2

RECALLING FIRM/MANUFACTURER

American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on April 12, 2011. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

PA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1746-11

CODE

Units: 017GV92560, 017GV92738

RECALLING FIRM/MANUFACTURER

The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on March 23, 2011 and by letters dated April 1, 2011 and April 25, 2011. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

MN

___________________________________

PRODUCT

Source Plasma. Recall # B-1748-11

CODE

Units: I75119280; I75118994; I75118564; I75118312; I75117828; I75117163; I75116852; I75116422; I75116167; 391005022; 391003441; 391002655; 391002120; 391001831; 391001295; 391001051; 391000502; I75120250; I75110668; I75110249; I75109946; I75108482; I75108176; I75107695; I75107407; I75106729; I75106172; I75103172; I75103608; I75103905; I75104802; I75105119; I75109076; I75109393; I75105845; I75100317; I75100614; I75100950; I75101451; I75101732; I75102150; I75102431; I75102850; I75092752; I75093016; I75098206; I75098471; I75098881; I75099316; I75089934; I75090674; I75091017; I75091262; I75091600; I75091825; I75092150; I75092391; I75087714; I75088249; I75088474; I75088767; I75088987; I75089329; I75089589; I75085850; I75086073; I75086333; I75086502; I75086909; I75081458; I75082015; I75082569; I75082969; I75085319; I75085574; I75075395; I75076447; I75077055; I75078586; I75079108; I75079691; I75080274; I75080850; I75067608; I75068176; I75071039; I75071733; I75072210; I75072733; I75073725; I75074266; I75061344; I75063924; I75064520; I75065090; I75065572; I75066064; I75066583; I75067068; I75057187; I75057693; I75058235; I75058716; I75059215; I75059719; I75060247; I75060768; I75052150; I75052720; I75053249; I75053738; I75054095; I75054620; I75055621; I75056635; I75049283; I75044242; I75045309; I75047471; I75047978; I75048487; I75049982; I75050522; I75048701; I75043121; I75042528; I75041954; I75041394; I75040837; I75036345; I75036308; I75086731; I75087403; I75087192; I75087928

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., North Las Vegas, NV, by telephone and facsimile on June 9, 2007. Firm initiated recall is complete.

REASON

Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

135 units

DISTRIBUTION

CA, KY, NC, NV and Austria

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1749-11

CODE

Unit: W045011024680

RECALLING FIRM/MANUFACTURER

Community Blood Center of Greater Kansas City, Kansas City, MO, by fax on June 11, 2011. Firm initiated recall is complete.

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

MO

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1750-11

CODE

Units: 7206271; 7206271

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 12, 2011. Firm initiated recall is complete.

REASON

Blood products, labeled leukoreduced which did not meet the QC requirements for leukoreduced products, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

TX

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1751-11

CODE

Unit: W142810357308

RECALLING FIRM/MANUFACTURER

Tri-counties Blood Bank, San Luis Obispo, CA, by letter dated June 13, 2011. Firm initiated recall is complete.

REASON

Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

Source Plasma. Recall # B-1754-11

CODE

Unit: 70200728640

RECALLING FIRM/MANUFACTURER

Csl Plasma, Inc., Aurora, CO, electronically on May 4, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who received an accidental needlestick within 3 months of donating, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Switzerland

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1766-11;

2) Cryoprecipitated AHF. Recall # B-1767-11

CODE

1) and 2) W035210002179Q

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.

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

Austria, TX, NC

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1774-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1775-11;

3) Cryoprecipitated AHF. Recall # B-1776-11

CODE

1) Unit: W053310603542;

2) Units: W053309607211; W053309605013; W053309603116; W053308605365; W053310608876; W053310606359;

3) Unit: W053310606359

RECALLING FIRM/MANUFACTURER

Community Blood Center, Inc., Appleton WI, by telephone and follow-up letter on May 4, 2011. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

8 units

DISTRIBUTION

Switzerland, MA, NY, MO, MS, WI

___________________________________

PRODUCT

1) Recovered Plasma. Recall # B-1777-11;

2) Cryoprecipitated AHF. Recall # B-1778-11;

3) Cryoprecipitated AHF, Pooled. Recall # B-1779-11

CODE

1) Unit: W036510044604;

2) Units: W036510044604; W036510153556;

3) Unit: W036510153556

RECALLING FIRM/MANUFACTURER

LifeShare Blood Centers, Shreveport LA, by facsimile on May 20, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

Switzerland and LA

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1780-11;

2) Cryoprecipitated AHF, Pooled. Recall # B-1782-11

CODE

1) Unit: 16KJ72174;

2) Unit: 16N43286

RECALLING FIRM/MANUFACTURER

American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.

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

OH, NJ, CA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced Irradiated Washed. Recall # B-1783-11

CODE

Unit: W066510602196

RECALLING FIRM/MANUFACTURER

Blood Bank of Alaska, Inc., Anchorage, AK, by telephone on May 24, 2011 and facsimile on June 7, 2011. Firm initiated recall is complete.

REASON

Blood product, mislabeled as to antigen phenotype, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AK

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1784-11

CODE

Unit: W041011033640* (2 units)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems, Inc., Albuquerque, New Mexico, by telephone on March 29, 2011.

Manufacturer: Blood Systems, Inc dba United Blood Services, Scottsdale, AZ. Firm initiated recall is complete.

REASON

Blood products, which were incorrectly labeled as negative for the Kell antigen, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

New Mexico

____________________________________

PRODUCT

Source Plasma Recall # B-1786-11

CODE

Unit: 5030111748

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., Atlantic Beach, FL, by facsimile on May 11, 2011. Firm initiated recall is complete.

REASON

Blood product, for which the sample for viral marker testing may have been diluted, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT

Platelets. Recall # B-1787-11

CODE

Unit: W087211004273

RECALLING FIRM/MANUFACTURER

Central Blood Bank, Pittsburgh, PA, by telephone and facsimile on April 25, 2011. Firm initiated recall is complete.

REASON

Blood product, associated with a red cell unit that may have been contaminated, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

PA

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1788-11

CODE

Unit: F24440

RECALLING FIRM/MANUFACTURER

Michigan Blood, Grand Rapids, MI, by electronic notification on May 20, 2011. Firm initiated recall is complete.

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

Switzerland

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1789-11

CODE

Unit # 53GG50054

RECALLING FIRM/MANUFACTURER

American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 5, 2011. Firm initiated recall is complete.

REASON

Blood product, for which the quality control testing was not performed, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MD

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-1790-11

CODE

Unit: W158011600314

RECALLING FIRM/MANUFACTURER

Arup Laboratories, Inc., Sandy, UT, by e-mail on May 20, 2011. Firm initiated recall is complete.

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

UT

___________________________________

PRODUCT

1) Cryoprecipitated AHF, Pooled. Recall # B-1791-11;

2) Recovered Plasma. Recall # B-1792-11;

3) Red Blood Cells.  Recall # B-1793-11;

4) Fresh Frozen Plasma. Recall # B-1794-11

CODE

1) Unit: W035410057932;

2) Unit: W035410068461;

3) Units: W035410068461, W035410033438;

4) Unit: W035410033438

RECALLING FIRM/MANUFACTURER

Community Blood Center, Dayton, OH, by telephone on May 12, 2011 and by facsimile on May 13 and 17, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION

Austria, OH

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1797-11

CODE

Unit: 7203222

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on May 12, 2011. Firm initiated recall is complete.

REASON

Blood product, which did not meet acceptable product specifications, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT

1) Fresh Frozen Plasma. Recall # B-1799-11;

2) Platelets. Recall # B-1800-11;

3) Red Blood Cells Leukocytes Reduced. Recall # B-1802-11

CODE

1) Units: W0352092626557; 9569604; W035209132071U;

2) Units: 9569604; W035209132071U;

3) Units: 9569604; W035209132071U; W0352092626557

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 24, 2011. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

8 units

DISTRIBUTION

TN, TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________

PRODUCT

Recovered Plasma. Recall # B-1620-11

CODE

Unit: W128708016088

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile on December 1, 2009. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose health history screening was inadequately performed, was distributed

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA and Austria

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1709-11

CODE

Units: W128709060865, W128709010584

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by telephone and follow-up letter dated March 6, 2009. Firm initiated recall is complete.

REASON

Blood product, was labeled with incorrect anticoagulant and product volumes, was distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1712-11;

2) Red Blood Cells. Recall # B-1713-11

CODE

1) Unit: P78322;

2) Units: T30644, P44737

RECALLING FIRM/MANUFACTURER

Delta Blood Bank, Stockton, CA, by facsimile dated March 16, 2009 and letter dated June 26, 2009. Firm initiated recall is complete.

REASON

Blood products, collected from a donor taking Doxycycline, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

CA and Austria

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-1733-11;

2) Fresh Frozen Plasma. Recall # B-1734-11

CODE

1) and 2) Unit: 2076869

RECALLING FIRM/MANUFACTURER

Hemacare Corp., Van Nuys, CA, by telephone on March 23, 2011 and by letter on March 31, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who previously tested HIV positive, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

NY, CA

___________________________________

PRODUCT

Source Plasma. Recall # B-1747-11

CODE

Unit: LT109376

RECALLING FIRM/MANUFACTURER

Pyramid Biological Corp. Las Vegas, NV, by facsimile on September 15, 2005. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Austria

___________________________________

PRODUCT

Recovered Plasma, Recall # B-1768-11

CODE

Unit: W035210002179Q

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 11, 2011 and by e-mail on May 11, 2011. Firm initiated recall is complete.

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, TX, NC

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1781-11

CODE

Unit: 16KJ72174

RECALLING FIRM/MANUFACTURER

American National Red Cross, Central Ohio Region, Columbus, OH, by letter on May 13, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

OH, NJ, CA

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-1785-11

CODE

Unit: W038111046791 (2 units)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by letter dated May 19, 2011.

Manufacturer: Florida's Blood Centers - Lake Worth, Palm Springs, FL. Firm initiataed recall is complete.

REASON

Blood products, which were stored at an unacceptable temperature, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

FL

___________________________________

PRODUCT

Recovered Plasma. Recall # B-1798-11

CODE

Unit: W089211024609

RECALLING FIRM/MANUFACTURER

Sanford Medical Center (Blood Bank), Sioux Falls, SD, by facsimile on June 7, 2011. Firm initiated recall is complete.

REASON

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

KY

___________________________________

PRODUCT

Source Leukocytes. Recall # B-1801-11

CODE

Unit: W035209132071U

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by letter dated May 24, 2011. Firm initiated recall is complete.

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

TN, TX