• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for October 26, 2005

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

October 26, 2005
05-43

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Henretty’s World Famous Jumbo Lump Crab Cake. The product is sold in yellow/orange Styrofoam trays that contain two 0.25 lb crab cakes, Recall # F-012-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Henretty’s Prime Meats, Hockessin, DE, by telephone on October 4, 2005, and by press release on October 5, 2005. Firm initiated recall is ongoing.
REASON
The product does not bear an ingredient statement and contains eggs.
VOLUME OF PRODUCT IN COMMERCE
10 trays
DISTRIBUTION
DE

______________________________
PRODUCT
Hostess Cookies -- Oatmeal, approximately 14 g each. Four cookies are packaged in a clear wrapper. Twelve packages of cookies are placed in each box, Recall # F-003-6
CODE
NOV 7---56132---0604
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Brands Corp. Hdqtrs, Kansas City, MO, by email on August 3, 2005 and by press release on August 8, 2005.
Manufacturer: Interstate Brands Companies, Wayne, NJ. Firm initiated recall is ongoing.
REASON
Chocolate chip cookies containing milk and eggs are packaged in Oatmeal cookie boxes which declare no milk or eggs in ingredient panel.
VOLUME OF PRODUCT IN COMMERCE
6,665 boxes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Jelly Sweet “Ulitochka”, Net Wt. 300 g. The product is packaged in a clear plastic shell, Recall # F-013-6
CODE
09/MAR/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Desly International Corp., Brooklyn, NY, by letters, dated July 29, 2005.
Manufacturer: JSC Krashnyj Moziryanin, Naroviya, Republic of Belarus. Firm initiated recall is complete.
REASON
The product contained the unapproved color Ponceau 4R (E124), and the undeclared color additives tartrazine (certifiable as FD&C Yellow #5) and brilliant blue FCF (certifiable as FD&C Blue #1).
VOLUME OF PRODUCT IN COMMERCE
195 cases (6 packages per case)
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________________
PRODUCT
a) 10% FreAmine III (Amino Acid Injection), 500 mL and
1000 mL Single dose container, Sterile, nonpyrogenic,
Rx only, NDA 0264-9011-55, Recall # D-004-6;
b) 8.5% FreAmine III (Amino Acid Injection) 500 mL
Single dose container, Sterile, nonpyrogenic, Rx only,
NDC 0264-9031-55, Recall # D-005-6;
c) 8.5% FreAmine III (Amino Acid Injection) with
Electrolytes, 500 mL and 1000 mL single dose containers,
Sterile nonpyrogenic, Rx only, NDC 0264-1931-10,
Recall # D-006-6;
d) HepatAmine (8% Amino Acid Injection) 500 mL Single dose
container, Steril, nonpyrogenic, Rx only, NDC 0264-9371-55,
Recall # D-007-6
CODE
a) 500 mL: Lot #: J4J059, J5B002, J4K011, J4S026
1000 mL: Lot #: J4K018, J4K020, J4K030, J4K037, J4K038;
b) Lot #: J4K010, J4S033, J4N032;
c) 500 mL: Lot #: J4S027, J5C002 1000 mL: Lot #: J5B027;
d) Lot #: J4K014
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Irvine, CA, by letter on October 7, 2005. Firm initiated recall is ongoing.
REASON
Product exceeds degradation specification (aluminum) 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
33,240 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Thyro-Tab, .050 mg, Bulk Drum Tablets,
For repacking, Rx only, Recall # D-009-6;
b) Levothroid (levothyroxine sodium tablets, USP), 50 mcg,
100 and 1000 count bottles, Rx only, Recall # D-010-6
CODE
a) Bulk: HA27104, HB27104, HC27104, HD27104, and HE27104,
all with an expiration date of October, 2005;
b) 100 count bottle: 110409, 110410; 1000 count bottle:
110433, 110434, and 110435 all with an expiration
date of October, 2005
RECALLING FIRM/MANUFACTURER
Lloyd Pharmaceutical, Shenandoah, IA, by telephone on September 6, 2005 and by letter on September 21, 2005. Firm initiated recall is ongoing.
REASON
Subpotent (9-month stability)
VOLUME OF PRODUCT IN COMMERCE
9,537,370 bulk tablets; Finished product - 37,610/100-tab. bottles, and 3,792/1,000-tab bottles.
DISTRIBUTION 
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
AccuHist PDX Syrup, Each 5mL (teaspoonful) contains: Brompheniramine Maleate, USP 2mg, Detromethorphan HBr, USP 5mg, Phenylephrine HCl, USP 5mg, and Guifenesin, USP 50mg, Alcohol Free, Grape Flavor, 1 pt (473mL) and 30mL bottles, Rx only, NDC 66346-181-65, Recall # D-008-6
CODE
Lot Nos.: L083M03A, exp 12/05; L087M03A, exp 01/06; L088M03A, exp 01/06; L014B04A, exp 02/06; L069D04A, exp 05/06; L004E04A, exp 05/06; L012H04A, exp 08/06; L017H04A, exp 08/06; L002B05A, exp 02/07; L003B05A, exp 02/07
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, LLC, Huntsville AL, by letter on September 27, 2005. Firm initiated recall is ongoing.
REASON
Subpotent; phenylephrine HCl (18 and 24 month stability)
VOLUME OF PRODUCT IN COMMERCE
462,127 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
PREMARIN (conjugated estrogens USP), 0.9 mg, 100-tablet bottles, Rx only, NDC 0046-0864-81, Recall # D-011-6
CODE
A45568, Exp. 12/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth Pharmaceuticals, Richmond, VA, by letters dated October 7, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Exceeds dissolution specifications (24-month stability)
VOLUME OF PRODUCT IN COMMERCE
99,793 bottles (of which 65,833 to wholesalers)
DISTRIBUTION 
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

_______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0237-6
CODE
Donor numbers for 2004 and 2005:
BM04-A101, BM04-A102, BM04-A103, BM04-A104, BM04-A105, BM04-A106, BM04-A107, BM04-A108, BM04-A109, BM04-A110, BM04-A111, BM04-A112, BM04-A113, BM04-A114, BM04-A115, BM04-A116, BM04-B101, BM04-B102, BM04-B103, BM04-B104, BM04-B105, BM04-B106, BM04-B107, BM04-B108, BM04-B109, BM04-B110, BM04-B111, BM04-B112, BM04-B113, BM04-B114, BM04-B115, BM04-B116, BM04-B117, BM04-B118, BM04-B119, BM04-B120, BM04-B121, BM04-B122, BM04-B123, BM04-B124, BM04-B125, BM04-B126, BM04-B127, BM04-C101, BM04-C102, BM04-C103, BM04-C104, BM04-C105, BM04-C106, BM04-C107, BM04-C108, BM04-C109, BM04-C110, BM04-C111, BM04-C112, BM04-C113, BM04-C114, BM04-C115, BM04-C116, BM04-C117, BM04-C118, BM04-C119, BM04-C120, BM04-C121, BM04-C122, BM04-C123, BM04-C124, BM04-D101, BM04-D101, BM04-D102, BM04-D102, BM04-D103, BM04-D103, BM04-D104, BM04-D105, BM04-D105, BM04-D106, BM04-D106, BM04-D107, BM04-D107, BM04-D108, BM04-D108, BM04-D109, BM04-D109, BM04-D110, BM04-D110, BM04-D111, BM04-D111, BM04-D112, BM04-D112, BM04-D113, BM04-D113, BM04-D114, BM04-D114, BM04-D115, BM04-D115, BM04-D116, BM04-D116, BM04-D117, BM04-D117, BM04-D118, BM04-D118, BM04-D119, BM04-D119, BM04-D120, BM04-D120, BM04-D121, BM04-D121, BM04-D122, BM04-D122, BM04-D123, BM04-D123, BM04-D124, BM04-D124, BM04-D125, BM04-D125, BM04-D126, BM04-D126, BM04-D127, BM04-D127, BM04-D128, BM04-D128, BM04-D129, BM04-D129, BM04-E101, BM04-E101, BM04-E102, BM04-E102, BM04-E103, BM04-E103, BM04-E104, BM04-E104, BM04-E105, BM04-E106, BM04-E106, BM04-E107, BM04-E107, BM04-E108, BM04-E109, BM04-E109, BM04-E110, BM04-E110, BM04-E111, BM04-E111, BM04-E112, BM04-E112, BM04-E113, BM04-E113, BM04-E114, BM04-E114, BM04-E115, BM04-E115, BM04-E116, BM04-E116, BM04-E117, BM04-E117, BM04-E118, BM04-E118, BM04-E119, BM04-E119, BM04-E120, BM04-E120, BM04-E121, BM04-E121, BM04-E122, BM04-E122, BM04-F016, BM04-F101, BM04-F102, BM04-F103, BM04-F104, BM04-F105, BM04-F107, BM04-F108, BM04-F109, BM04-F110, BM04-F111, BM04-F112, BM04-F113, BM04-F114, BM04-F115, BM04-F116, BM04-F117, BM04-F118, BM04-F119, BM04-F120, BM04-F121, BM04-F122, BM04-F123, BM04-F124, BM04-F125, BM04-F126, BM04-F127, BM04-F128, BM04-F129, BM04-F130, BM04-F131, BM04-F132, BM04-F133, BM04-F134, BM04-F135, BM04-F136, BM04-F137, BM04-F138, BM04-F139, BM04-F140, BM04-F141, BM04-F142, BM04-F143, BM04-F145, BM04-G101, BM04-G102, BM04-G103, BM04-G104, BM04-G105, BM04-G106, BM04-G107, BM04-G108, BM04-G109, BM04-G110, BM04-G111, BM04-G112, BM04-G113, BM04-G114, BM04-G115, BM04-G116, BM04-G117, BM04-G118, BM04-G119, BM04-G120, BM04-G121, BM04-G122, BM04-G123, BM04-G124, BM04-G125, BM04-G126, BM04-G127, BM04-G128, BM04-G129, BM04-G130, BM04-G131, BM04-G132, BM04-G133, BM04-G134, BM04-G135, BM04-G136, BM04-G137, BM04-G138, BM04-G139, BM04-G140, BM04-G141, BM04-G142, BM04-G143, BM04-H101, BM04-H102, BM04-H103, BM04-H104, BM04-H105, BM04-H106, BM04-H107, BM04-H108, BM04-H109, BM04-H110, BM04-H111, BM04-H112, BM04-H113, BM04-H114, BM04-H115, BM04-H116, BM04-H117, BM04-H118, BM04-H119, BM04-H120, BM04-H121, BM04-H122, BM04-H123, BM04-H124, BM04-H125, BM04-H126, BM04-H127, BM04-H128, BM04-H129, BM04-H130, BM04-H131, BM04-H132, BM04-H133, BM04-H134, BM04-H135, BM04-H136, BM04-I101, BM04-I102, BM04-I103, BM04-I104, BM04-I105, BM04-I106, BM04-I107, BM04-I108, BM04-I109, BM04-I110, BM04-I111, BM04-I112, BM04-I113, BM04-I114, BM04-I115, BM04-I116, BM04-I117, BM04-I118, BM04-I119, BM04-I120, BM04-I121, BM04-I121, BM04-I122, BM04-I123, BM04-I124, BM04-I125, BM04-I126, BM04-I127, BM04-I128, BM04-I129, BM04-I129, BM04-I130, BM04-I131, BM04-I132, BM04-I133, BM04-I134, BM04-I135, BM04-I136, BM04-I137, BM04-J117, BM04-J121, BM04-J131, BM04-J132, BM04-J133, BM04-J134, BM04-J135, BM04-J136, BM04-J137, BM04-J138, BM04-J139, BM04-J140, BM04-J141, BM04-J142, BM04-J143, BM04-K101, BM04-K102, BM04-K103, BM04-K104, BM04-K105, BM04-K106, BM04-K107, BM04-K108, BM04-K109, BM04-K110, BM04-K111, BM04-K112, BM04-K113, BM04-K114, BM04-K115, BM04-K116, BM04-K117, BM04-K118, BM04-K119, BM04-K120, BM04-K121, BM04-K122, BM04-K123, BM04-K124, BM04-K125, BM04-K126, BM04-K127, BM04-K128, BM04-L101, BM04-L102, BM04-L103, BM04-L104, BM04-L105, BM04-L106, BM04-L107, BM04-L108, BM04-L109, BM04-L110, BM04-L111, BM04-L112, BM04-L113, BM04-L114, BM04-L115, BM04-L116, BM04-L117, BM04-L118, BM04-L119, BM04-L120, BM04-L121, BM04-L122, BM04-L123, BM04-L124, BM04-L125, BM04-L126, BM04-L127, BM04-L128, BM04-L129, BM04-L130, BM04-L131, BM04-L132, BM04-L133, BM05-A101, BM05-A102, BM05-A103, BM05-A104, BM05-A105, BM05-A106, BM05-A107, BM05-A108, BM05-A109, BM05-A110, BM05-A111, BM05-A112, BM05-A113, BM05-A114, BM05-A115, BM05-A117, BM05-A118, BM05-A119, BM05-A120, BM05-A121, BM05-A122, BM05-A123, BM05-A124, BM05-A125, BM05-A126, BM05-A127, BM05-A128, BM05-A129, BM05-A130, BM05-A131, BM05-A132, BM05-A133, BM05-A134, BM05-B101, BM05-B102, BM05-B103, BM05-B104, BM05-B105, BM05-B106, BM05-B107, BM05-B108, BM05-B109, BM05-B110, BM05-B111, BM05-B112, BM05-B113, BM05-B114, BM05-B115, BM05-B116, BM05-B117, BM05-B118, BM05-B119, BM05-B120, BM05-B121, BM05-B122, BM05-B123, BM05-B124, BM05-B125, BM05-B126, BM05-B127, BM05-B128, BM05-B129, BM05-B130, BM05-B131, BM05-B132, BM05-B133, BM05-B134, BM05-B135, BM05-B136, BM05-B137, BM05-B138, BM05-B139, BM05-B140, BM05-B141, BM05-B142, BM05-B143, BM05-B144, BM05-B145, BM05-B146, BM05-B147, BM05-B148, BM05-B149, BM05-B150, BM05-B151, BM05-B152, BM05-C101, BM05-C102, BM05-C103, BM05-C104, BM05-C105, BM05-C106, BM05-C107, BM05-C108, BM05-C109, BM05-C110, BM05-C111, BM05-C112, BM05-C113, BM05-C114, BM05-C115, BM05-C116, BM05-C117, BM05-C118, BM05-C119, BM05-C120, BM05-C121, BM05-C122, BM05-C123, BM05-C124, BM05-C125, BM05-C126, BM05-C127, BM05-C128, BM05-C129, BM05-C130, BM05-C131, BM05-C132, BM05-C133, BM05-C134, BM05-C135, BM05-C136, BM05-C137, BM05-C138, BM05-C139, BM05-C140, BM05-C141, BM05-C142, BM05-C143, BM05-C144, BM05-C145, BM05-C146, BM05-C147, BM05-C148, BM05-C149, BM05-C150, BM05-C151, BM05-C152, BM05-C153, BM05-D101, BM05-D102, BM05-D103, BM05-D104, BM05-D105, BM05-D106, BM05-D107, BM05-D108, BM05-D109, BM05-D110, BM05-D111, BM05-D112, BM05-D113, BM05-D114, BM05-D115, BM05-D116, BM05-D117, BM05-D118, BM05-D119, BM05-D120, BM05-D121, BM05-D122, BM05-D123, BM05-D124, BM05-D125, BM05-D126, BM05-D127, BM05-D128, BM05-D129, BM05-D130, BM05-D131, BM05-D132, BM05-D133, BM05-D134, BM05-D135, BM05-D136, BM05-D137, BM05-D138, BM05-D139, BM05-D140, BM05-E101, BM05-E102, BM05-E103, BM05-E104, BM05-E105, BM05-E106, BM05-E107, BM05-E108, BM05-E109, BM05-E110, BM05-E111, BM05-E112, BM05-E113, BM05-E114, BM05-E115, BM05-E116, BM05-E117, BM05-E118, BM05-E119, BM05-E120, BM05-E121, BM05-E122, BM05-E123, BM05-E124, BM05-E125, BM05-E126, BM05-E127, BM05-E128, BM05-E129, BM05-E130, BM05-E131, BM05-E132, BM05-E133, BM05-E134, BM05-E135, BM05-E136, BM05-E137, BM05-E138, BM05-E139, BM05-E140, BM05-E141, BM05-E142, BM05-F101, BM05-F102, BM05-F103, BM05-F104, BM05-F105, BM05-F106, BM05-F107, BM05-F108, BM05-F109, BM05-F110, BM05-F111, BM05-F112, BM05-F113, BM05-F114, BM05-F115, BM05-F116, BM05-F117, BM05-F118, BM05-F119, BM05-F120, BM05-F121, BM05-F122, BM05-F123, BM05-F124, BM05-F125, BM05-F126, BM05-F127, BM05-F128, BM05-F129, BM05-F130, BM05-F131, BM05-F132, BM05-F133, BM05-F134, BM05-F135, BM05-F136, BM05-F137, BM05-F138, BM05-F139, BM05-F140, BM05-F141, BM05-F142, BM05-F143, BM05-G101, BM05-G102, BM05-G103, BM05-G104, BM05-G105, BM05-G106, BM05-G107, BM05-G108, BM05-G109, BM05-G110, BM05-G111, BM05-G112, BM05-G113, BM05-G114, BM05-G115, BM05-G116, BM05-G117, BM05-G118, BM05-G119, BM05-G120, BM05-G121, BM05-G122, BM05-G123, BM05-G124, BM05-G125, BM05-G126, BM05-G127, BM05-G128, BM05-G129, BM05-G130, BM05-G131, BM05-G132, BM05-G133, BM05-G134, BM05-G135, BM05-G136, BM05-G137, BM05-G138, BM05-G139, BM05-G140, BM05-G141, BM05-G142, BM05-G143, BM05-G144, BM05-G145, BM05-G146, BM05-G147, BM05-H101, BM05-H102, BM05-H103, BM05-H104, BM05-H105, BM05-H106, BM05-H107, BM05-H108, BM05-H109, BM05-H110, BM05-H111, BM05-H112, BM05-H113, BM05-H114, BM05-H115, BM05-H116, BM05-H117, BM05-H118, BM05-H119, BM05-H120, BM05-H121, BM05-H122, BM05-H123, BM05-H124, BM05-H125, BM05-H126, BM05-H127, BM05-H128, BM05-H129, BM05-H130, BM05-H131, BM05-H132, BM05-H133, BM05-H134, BM05-H135, BM05-H136, BM05-H137, BM05-H138, BM05-H139, BM05-H140, BM05-H141, BM05-H142, BM05-H143, BM05-H144, BM05-H145, BM05-H148
RECALLING FIRM/MANUFACTURER
BioMedical Tissue Services, LTD, Fort Lee, NJ, by telephone on October 3, 2005, and by letter dated October 13, 2005. Firm initiated recall is ongoing.
REASON
Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
Human Tissue Collected from 761 donors
DISTRIBUTION 
NJ, FL, AL, TX, and GA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0001-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0002-6
CODE
a) Unit number: 6605344;
b) Unit numbers: 6635693 and 7035841
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO and PA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0003-6
CODE
Unit numbers: 6419282 and 6613102
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0004-6
CODE
Unit number: 6417437
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0005-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0006-6
CODE
a) Unit number: 7020814;
b) Unit numbers: 7040969 and 7030236
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0007-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0008-6
CODE
a) Unit number: 6574718;
b) Unit number: 6622166
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0016-6
CODE
Unit numbers: 6843802 and 6841057
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 6, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0017-6
CODE
Unit number: 6910785
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 12, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0018-6
CODE
Unit number: 6586552
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 7, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0019-6
CODE
Unit number: 7049574
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 7, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0020-6
CODE
Unit numbers: 0753213 and 0748414
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 7, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0021-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0022-6
CODE
a) Unit numbers: 7014526 and 7008695;
b) Unit number: 7004547
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0023-6
CODE
Unit number: 6863510
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
AL

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0024-6
CODE
Unit number: 6883569
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0025-6
CODE
Unit number: 6602842
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0026-6
CODE
Unit numbers: 6414545 and 7015446
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO and MS

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0027-6
CODE
Unit number: 6415163
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0028-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0029-6
CODE
a) Unit number: 6827554;
b) Unit number: 6829645
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO and IL

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0030-6
CODE
Unit numbers: 6829646 and 6827555
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 26, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0031-6
CODE
Unit number: 7024098
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 26, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0032-6
CODE
Unit numbers: 6829277, 6825895, 6823674 and 6820450
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 26, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO and FL

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0035-6
CODE
Unit numbers: 6884654
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September 23, 2003. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0036-6;
b) Fresh Frozen Plasma, Recall # B-0037-6
CODE
a) Unit numbers: 100400606, 100400612, 100400613, 100400614,
100400615, 100400616, 100400618, 100400619, 100400621,
100400623, 100400624, 100400626;
b) Unit numbers: 100400606, 100400612, 100400613,
100400614, 100400615, 100400616, 100400618,
100400619, 100400620, 100400621, 100400623, 100400626
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 10, 2003, and by letter on December 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
AZ, ND, and SD

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0038-6;
b) Platelet, Leukocytes Reduced, Recall # B-0039-6
CODE
a) and b) Unit number: 13FV49860
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on May 31, 2005, and by letter on June 2, 2005. Firm initiated recall is complete.
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
MI

_______________________________
PRODUCT
Platelet Pheresis, Leukocytes Reduced, Recall # B-0040-6
CODE
Unit numbers: 0751728 part 1 & 2
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0044-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0045-6
CODE
a) Unit numbers: 6948703 and 7035863;
b) Unit number: 6950646
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 27, 2004. Firm initiated recall is complete.
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
3 units
DISTRIBUTION
CO, IL, and VA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0046-6
CODE
Unit number: 6627474
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 26, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0047-6
CODE
Unit number: 6950715
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 17, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0048-6
CODE
Unit number: 7028811
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 22, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0049-6
CODE
Unit number: 6887065
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 29, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0050-6
CODE
Unit number: 0759240
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 22, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0051-6
CODE
Unit number: 6873256
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 5, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0052-6
CODE
Unit number: 6632179
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 27, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0064-6
CODE
Unit number: 6824561
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0065-6
CODE
Unit number: 6151399
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0066-6
CODE
Unit number: 7012674
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0067-6
CODE
Unit numbers: 6825432 and 6570732 (2 parts)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0068-6
CODE
Unit numbers: 6176778 and 7005754
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0069-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0070-6
CODE
a) Unit numbers: 6165886 and 6145166;
b) Unit number: 6151057
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO and FL

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0071-6
CODE
Unit number: 6175171
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which was 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
MS

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0072-6
b) Red Blood Cells Leukocytes Reduced, Recall # B-0073-6
CODE
a) Unit numbers: 6826765 and 6328772;
b) Unit number: 6820967
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0086-6;
b) Recovered Plasma, Recall # B-0087-6
CODE
a) and b) Unit number: 6880248
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0106-6
CODE
Unit number: 0749169
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 20, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0108-6
CODE
Unit numbers: 6316110 and 6324307
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 22, 2004. Firm initiated recall is complete.
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
CO

_______________________________
PRODUCT
Source Plasma, Recall # B-0118-6
CODE
Unit numbers: 04OUTB3489, 04OUTB3721, and 04OUTB4252
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Ogden, UT, by facsimile on November 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reportedly had engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0131-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0132-6;
c) Red Blood Cells Leukocytes Reduced Irradiated,
Recall # B-0133-6;
d) Red Blood Cells (Apheresis), Recall # B-0134-6;
e) Fresh Frozen Plasma, Recall # B-0135-6;
f) Plasma, Recall # B-0136-6;
CODE
a) Unit numbers: 004GF48097, 004GF48113, 004GF48307,
004GF48308, 004GF48525, 004GF48770, 004GF48793,
004GF48824, 004R29554, 004R29561, 004R30169, and 004S71044;
b) Units 004GF47660, 004GF47661, 004GF47665, 004GF47666,
004GF47754, 004GF47755, 004GF47757, 004GF47760, 004GF47765,
004GF47778, 004GF47782, 004GF47783, 004GF47786, 004GF47788,
004GF47964, 004GF47969, 004GF47971, 004GF47974, 004GF47978,
004GF47987, 004GF47988, 004GF47989, 004GF47993, 004GF48006,
004GF48012, 004GF48074, 004GF48096, 004GF48101, 004GF48104,
004GF48105, 004GF48285, 004GF48298, 004GF48301, 004GF48303,
004GF48312, 004GF48317, 004GF48324, 004GF48386, 004GF48387,
004GF48448, 004GF48449, 004GF48451, 004GF48453, 004GF48454,
004GF48513, 004GF48527, 004GF48681, 004GF48683, 004GF48684,
004GF48687, 004GF48784, 004GF48786, 004GF48788, 004GF48790,
004GF48797, 004GF48801, 004GF48803, 004GF48805, 004GF48807,
004GF48820, 004GF49449, 004GF49450, 004GF49456, 004GF49457,
004GF49459, 004GF49460, 004GF49533, 004GF49543, 004GF49545,
004GF49549, 004GF49551, 004GF49554, 004R29145, 004R29147,
004R29149, 004R29150, 004R29153, 004R29310, 004R29349,
004R29354, 004R29523, 004R29526, 004R29530, 004R29542,
004R29551, 004R29556, 004R29566, 004R29569, 004R29572,
004R29576, 004R29577, 004R29581, 004R29619, 004R29623,
004R29648, 004R29652, 004R30040, 004R30057, 004R30062,
004R30067, 004R30068, 004R30073, 004R30074, 004R30075,
004R30077, 004R30092, 004R30093, 004R30096, 004R30171,
004R30175, 004R30190, 004R30194, 004R30198, 004R30207,
004R30211, 004R30217, 004R30231, 004R30235, 004R30306,
004R30310, 004R30316, 004R30320, 004R30329, 004R30332,
004R30336, 004R30338, 004R30348, 004R30349, 004R30351,
004R30507, 004R30509, 004R30514, 004R30516, 004R30532,
004R30534, 004R30535, 004R30538, 004R30539, 004R30541,
004R30544, 004R30571, 004R30573, 004R30592, 004R30595,
004R30598, 004R30600, 004R30662, 004R30665, 004R30671,
004R30693, 004R30696, 004R30706, 004R30709, 004R30721,
004R30732, 004R30735, 004R30746, 004R30748, 004R30750,
004R30751, 004R30757, 004R30762, 004R30764, 004R30770,
004R30779, 004R30852, 004R30855, 004R30856, 004R30867,
004R30869, 004R30871, 004R30872, 004R31089, 004R31091,
004R31118, 004R31121, 004R31124, 004R31125, 004R31128,
004R31231, 004R31234, 004R31236, 004R31251, 004R31253,
004R31282, 004R31284, 004R31287, 004R31316, 004R31318,
004R31339, 004R31341, 004R31344, 004R31347, 004R31359,
004R31360, 004R31363, 004R31366, 004R31367, 004R31368,
004R31369, 004R31670, 004R31683, 004R31709, 004R31711,
004R31727, 004R31737, 004R31750, 004R31752, 004R31756,
004R31760, 004R31763, 004R31773, 004R31777, 004R31780,
004R31783, 004R31789, 004R31809, 004R31812, 004R31821,
004R31826, 004R31828, 004R31832, 004R31835, 004R31908,
004R31914, 004R31925, 004R31952, 004R31955, 004R31962,
004R31966, 004R31969, 004R31973, 004R31977, 004R31984,
004R31987, 004R32009, 004R32010, 004R32324, 004R32327,
004R32328, 004R32330, 004R32331, 004R32336, 004R32342,
004R32345, 004R32347, 004R32349, 004R32355, 004R32356,
004R32358, 004R32363, 004R32378, 004R32402, 004R32405,
004R32408, 004R32412, 004S70449, 004S70451, 004S70453,
004S70458, 004S70488, 004S70505, 004S70507, 004S70511,
004S70611, 004S70625, 004S70626, 004S70643, 004S70646,
004S70648, 004S71035, 004S71053, 004S71054, 004S71069,
004S71077, 004S71080, 004S71096, 004S71100, 004S71103,
004S71106, 004S71123, 004S71127, 004S71134, 004S71142,
004S71156, 004S71166, 004S71486, 004S71490, 004S71967,
004S71974, 004S71978, 004S71980, 004S72009, 004S72013,
004S72015, 004S72018, 004S72021, 004S72158, 004S72176,
004S72177, 004S72181, 004S72184, 004S72187, 004S72489,
004S72494, 004S72511, 004S72543, 004S72548, 004S72551,
004S72582, 004S72586, 004S72589, 004S72592, 004S72594,
004S72596, 004S72612, 004S72616, 004S72619, 004S72625,
004S72626, 004S72630, 004S72632, 004S72637, 004S72640,
004S72833, 004S72836, 004S72845, 004S72850, 004S72851,
004S72858, 004S72861, 004S72884, 004S72890, 004T40548,
and 004T40550;
c) Units 004GF47967, 004GF47984, 004GF48102, 004GF48385,
004R29345, 004R29559, 004R30195, 004R30754, 004R30766,
004R30768, 004R30774, 004R30777, 004R30782, 004R30859,
004R31248, 004R31314, 004R31658, 004R31793, 004R31959,
004R32011, 004R32014, 004S71030, 004S71480, 004S72590,
004S72623, 004S72882, 004S72886;
d) Units 004GX07429R2, 004GX07429R1, 004GY06608, 004GY06762R1,
and 004GY06762R2;
e) Units 004GF47964, 004GF47969, 004GF47971, 004GF47974,
004GF47978, 004GF47984, 004R30507, 004R30509, 004R30514,
004R30516, 004R30532, 004R30534, 004R30535, 004R30538,
004R30539, 004R30541, 004R30544, 004R31229, 004R31231,
004R31234, 004R31236, 004R31248, 004R31251, 004R31253,
004R31344, 004R31347, 004R31359, 004R31360, 004R31363,
004R31366, 004R31369, 004S70507, 004S72158, 004S72176,
004S72177, 004S72184, and 004S72873;
f) Units 004GF48386, 004GF48387, 004GF48807, 004GF48817,
004R30040, 004R30057, 004R30062, 004R30067, 004R30068,
004R30073, 004R30074, 004R30075, 004R30077, 004R30092,
004R30093, and 004R30096
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by telephone on June 22, 2005, by facsimile on June 22 and 23, 2005, and/or by letter dated June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
432 units
DISTRIBUTION
CA, MA, ME, NH, NY, PA and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT

Platelets Pheresis, Leukocytes Reduced, Recall # B-0080-6
CODE
Unit 6837223 part 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 20, 2004. Firm initiated recall is complete.
REASON
Blood products, mislabeled as leukocytes reduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0081-6
CODE
Unit 0758826
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 13, 2003. Firm initiated recall is complete.
REASON
Blood product, mislabeled as leukocytes reduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0094-6
CODE
Unit number: 4280084
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and by letter dated May 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which was shipped at potentially unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0119-6
CODE
Unit number: 3423284
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone and letter dated August 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which may not have met product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0137-6
CODE
Unit numbers: 004GF47660, 004GF47661, 004GF47665, 004GF47666, 004GF47754, 004GF47755, 004GF47757, 004GF47760, 004GF47765, 004GF47778, 004GF47782, 004GF47783, 004GF47786, 004GF47788, 004GF47967, 004GF47987, 004GF47988, 004GF47989, 004GF47993, 004GF48006, 004GF48012, 004GF48074, 004GF48096, 004GF48097, 004GF48101, 004GF48102, 004GF48104, 004GF48105, 004GF48285, 004GF48298, 004GF48301, 004GF48303, 004GF48307, 004GF48308, 004GF48312, 004GF48317, 004GF48324, 004GF48448, 004GF48449, 004GF48451, 004GF48453, 004GF48454, 004GF48513, 004GF48521, 004GF48527, 004GF48681, 004GF48683, 004GF48684, 004GF48687, 004GF48784, 004GF48786, 004GF48788, 004GF48790, 004GF48797, 004GF48801, 004GF48803, 004GF48805, 004R29145, 004R29147, 004R29149, 004R29150, 004R29153, 004R29310, 004R29345, 004R29349, 004R29354, 004R29522, 004R29523, 004R29526, 004R29530, 004R29542, 004R29551, 004R29556, 004R29559, 004R29566, 004R29569, 004R29572, 004R29576, 004R29577, 004R29581, 004R29619, 004R29623, 004R29648, 004R29652, 004R30171, 004R30175, 004R30190, 004R30194, 004R30195, 004R30198, 004R30204, 004R30207, 004R30211, 004R30217, 004R30231, 004R30235, 004R30306, 004R30310, 004R30316, 004R30320, 004R30329, 004R30332, 004R30336, 004R30338, 004R30348, 004R30349, 004R30351, 004R30571, 004R30573, 004R30592, 004R30595, 004R30598, 004R30600, 004R30662, 004R30665, 004R30671, 004R30693, 004R30696, 004R30706, 004R30709, 004R30721, 004R30732, 004R30735, 004R30746, 004R30748, 004R30750, 004R30751, 004R30754, 004R30757, 004R30762, 004R30764, 004R30766, 004R30768, 004R30770, 004R30774, 004R30777, 004R30779, 004R30782, 004R30852, 004R30855, 004R30856, 004R30859, 004R30867, 004R30869, 004R30871, 004R30872, 004R31089, 004R31091, 004R31118, 004R31121, 004R31124, 004R31125, 004R31128, 004R31282, 004R31284, 004R31287, 004R31314, 004R31316, 004R31318, 004R31367, 004R31658, 004R31670, 004R31683, 004R31709, 004R31711, 004R31727, 004R31737, 004R31750, 004R31752, 004R31756, 004R31760, 004R31763, 004R31773, 004R31777, 004R31780, 004R31783, 004R31789, 004R31793, 004R31809, 004R31812, 004R31821, 004R31826, 004R31828, 004R31832, 004R31835, 004R31908, 004R31914, 004R31925, 004R31928, 004R31952, 004R31955, 004R31959, 004R31962, 004R31966, 004R31969, 004R31973, 004R31977, 004R31984, 004R31987, 004R32009, 004R32010, 004R32011, 004R32014, 004R59549, 004S70449, 004S70451, 004S70453, 004S70458, 004S70488, 004S70505, 004S70511, 004S70611, 004S70625, 004S70626, 004S70643, 004S70646, 004S70648, 004S71030, 004S71035, 004S71053, 004S71054, 004S71069, 004S71077, 004S71080, 004S71096, 004S71100, 004S71103, 004S71106, 004S71123, 004S71127, 004S71134, 004S71135, 004S71135, 004S71142, 004S71156, 004S71166, 004S71480, 004S71486, 004S71490, 004S71507, 004S71967, 004S71974, 004S71978, 004S71980, 004S72009, 004S72013, 004S72015, 004S72018, 004S72021, 004S72187, 004S72489, 004S72494, 004S72511, 004S72543, 004S72548, 004S72551, 004S72582, 004S72586, 004S72589, 004S72590, 004S72592, 004S72594, 004S72596, 004S72612, 004S72616, 004S72619, 004S72622, 004S72623, 004S72625, 004S72626, 004S72630, 004S72632, 004S72637, 004S72640, 004T40548, and 004T40550
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by telephone on June 22, 2005, by facsimile on June 22 and 23, 2005, and/or by letter dated June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
277 units
DISTRIBUTION
CA, MA, ME, NH, NY, PA and Switzerland

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

______________________________
PRODUCT
VeriCal Calibrator Set, Recall # Z-0032-06
CODE
Lot numbers: 161813, 161907, 161908, and 161909
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc., Durham, NC, by letter, on/about August 31, 2005. Firm initiated recall is ongoing.
REASON
The product is being recalled due to mis-assignment of ISI values associated with VeriCal use. This could lead to inaccurate patient INR results.
VOLUME OF PRODUCT IN COMMERCE
2,334 kits
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) FreeStyle FLASH Blood Glucose Monitoring System,
Recall # Z-0042-06;
b) Tracker Blood Glucose Monitoring System,
Recall # Z-0043-06;
c) Xceed Blood Glucose Monitoring System,
Recall # Z-0044-06;
d) ReliOn Ultima Glucose Monitoring System,
Recall # Z-0045-06;
e) Kroger Glucose Monitoring System, Recall # Z-0046-06;
f) RiteAid Glucose Monitoring System, Recall # Z-0047-06;
g) Liberty Glucose Monitoring System, Recall # Z-0048-06;
h) Boots Glucose Monitoring System, Recall # Z-0049-06;
i) Optium Glucose Monitoring System, Recall # Z-0050-06;
j) Xtra Classic Glucose Monitoring System,
Recall # Z-0051-06;
k) Easy Glucose Monitoring System, Recall # Z-0052-06;
l) SofTrac Glucose Monitoring System, Recall # Z-0053-06;
m) FreeStyle Glucose Monitoring System, Recall # Z-0054-06
CODE
a) All lot numbers beginning with R and all lot
numbers T-G158-62981 and below are included.
b) All lot numbers beginning with E are included in
the recall;
c) All lot numbers beginning with XC0999 and below
are included in this recall;
d), e), f), g), h), i), j), k), and l) All lot numbers
are included in this recall;
m) For lot numbers beginning with A, B, C, D, G, H, K,
and M, all lot numbers are included. All lot numbers
from V-G157-31584 and below are included, and also
all lot numbers Y-G018-32983 and below are included
in the recall.
RECALLING FIRM/MANUFACTURER
Abbott Diabetes Care, Inc., Alameda, CA, by letter, on June 7, 2005, and by a flyer in Precision Xtra and FreeStyle meter kits. Firm initiated recall is ongoing.
REASON
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
VOLUME OF PRODUCT IN COMMERCE
Approximately 10,005,206 meters
DISTRIBUTION
Nationwide and Internationally

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Nichols Advantage QuiCk-Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045, Recall # Z-0056-06
CODE
Lot 62-402651
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clemente, CA, by letter on April 14, 2005. Firm initiated recall is ongoing.
REASON
Controls were out of specification range.
VOLUME OF PRODUCT IN COMMERCE
323 units
DISTRIBUTION
Nationwide, Japan, Spain, Germany, and Sweden
______________________________
PRODUCT
Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE, Recall # Z-0057-06
CODE
Lot numbers: 13027030 to 13044734
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letters dated August 8, 2005. Firm initiated recall is ongoing.
REASON
Increased complaints regarding catheters with leaks and flow obstruction.
VOLUME OF PRODUCT IN COMMERCE
9,679 units
DISTRIBUTION
FL, IL, MA, MI, OH, OK and Internationally

_______________________________
PRODUCT
a) Scorpio Total Knee Cruciate Retaining Femoral Component,
#7, left, Catalog No. 70-4107L. 1 each to a package,
Recall # Z-0058-06;
b) Scorpio Total Knee Cruciate Retaining Femoral Component,
#7, right, Catalog No. 70-4107R. 1 each to a package,
Recall # Z-0059-06
CODE
a) Lot Code: K04W537;
b) Lot code: K04W896
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 11, 2005. Firm initiated recall is ongoing.
REASON
The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
T2 Recon Nail System, Recall @ Z-0060-06
CODE
Catalog No./Description/Lot Code: 18976065S-- T2 Recon Lag Screw 6.5x65MM--K454322; T2 Recon Lag Screw 6.5x65MM--K518614; T2 Recon Lag Screw 6.5x65MM--K518615; T2 Recon Lag Screw 6.5x65MM--K518616; T2 Recon Lag Screw 6.5x65MM--K518617; T2 Recon Lag Screw 6.5x65MM--K678251; T2 Recon Lag Screw 6.5x65MM--K678252. 18976070S-- T2 Recon Lag Screw 6.5x70MM--K412886; T2 Recon Lag Screw 6.5x70MM--K412887; T2 Recon Lag Screw 6.5x70MM--K454324; T2 Recon Lag Screw 6.5x70MM--K497821; T2 Recon Lag Screw 6.5x70MM--K518728; T2 Recon Lag Screw 6.5x70MM--K678253; T2 Recon Lag Screw 6.5x70MM--K678254. 18976075S-- T2 Recon Lag Screw 6.5x75MM--K400117; T2 Recon Lag Screw 6.5x75MM--K454326; T2 Recon Lag Screw 6.5x75MM--K518854; T2 Recon Lag Screw 6.5x75MM--K518855; T2 Recon Lag Screw 6.5x75MM--K518857; T2 Recon Lag Screw 6.5x75MM--K518858; T2 Recon Lag Screw 6.5x75MM--K678255; T2 Recon Lag Screw 6.5x75MM--K678256. 18976080S-- T2 Recon Lag Screw 6.5x80MM--K400118; T2 Recon Lag Screw 6.5x80MM--K454327; T2 Recon Lag Screw 6.5x80MM--K519005; T2 Recon Lag Screw 6.5x80MM--K519008; T2 Recon Lag Screw 6.5x80MM--K519009; T2 Recon Lag Screw 6.5x80MM--K678257; T2 Recon Lag Screw 6.5x80MM--K678258. 18976085S-- T2 Recon Lag Screw 6.5x85MM--K400119; T2 Recon Lag Screw 6.5x85MM--K412895; T2 Recon Lag Screw 6.5x85MM--K454328; T2 Recon Lag Screw 6.5x85MM--K488715; T2 Recon Lag Screw 6.5x85MM--K519003; T2 Recon Lag Screw 6.5x85MM--K519176; T2 Recon Lag Screw 6.5x85MM--K519177; T2 Recon Lag Screw 6.5x85MM--K519178; T2 Recon Lag Screw 6.5x85MM--K519182; T2 Recon Lag Screw 6.5x85MM--K519183; T2 Recon Lag Screw 6.5x85MM--K519184; T2 Recon Lag Screw 6.5x85MM--K519185; T2 Recon Lag Screw 6.5x85MM--K519186; T2 Recon Lag Screw 6.5x85MM--K678259; T2 Recon Lag Screw 6.5x85MM--K678260; T2 Recon Lag Screw 6.5x85MM--K757952. 18976090S-- T2 Recon Lag Screw 6.5x90MM--K400120; T2 Recon Lag Screw 6.5x90MM--K454329; T2 Recon Lag Screw 6.5x90MM--K488717; T2 Recon Lag Screw 6.5x90MM--K519286; T2 Recon Lag Screw 6.5x90MM--K519288; T2 Recon Lag Screw 6.5x90MM--K519289; T2 Recon Lag Screw 6.5x90MM--K519290; T2 Recon Lag Screw 6.5x90MM--K519291; T2 Recon Lag Screw 6.5x90MM--K519292; T2 Recon Lag Screw 6.5x90MM--K519293; T2 Recon Lag Screw 6.5x90MM--K678262; T2 Recon Lag Screw 6.5x90MM--K757953. 18976095S-- T2 Recon Lag Screw 6.5x95MM--K400121; T2 Recon Lag Screw 6.5x95MM--K412911; T2 Recon Lag Screw 6.5x95MM--K412914; T2 Recon Lag Screw 6.5x95MM--K412920; T2 Recon Lag Screw 6.5x95MM--K454330; T2 Recon Lag Screw 6.5x95MM--K488720; T2 Recon Lag Screw 6.5x95MM--K519401; T2 Recon Lag Screw 6.5x95MM--K519402; T2 Recon Lag Screw 6.5x95MM--K519405; T2 Recon Lag Screw 6.5x95MM--K519406; T2 Recon Lag Screw 6.5x95MM--K519407; T2 Recon Lag Screw 6.5x95MM--K519408; T2 Recon Lag Screw 6.5x95MM--K669388; T2 Recon Lag Screw 6.5x95MM--K678264; T2 Recon Lag Screw 6.5x95MM--K757954. 18976100S-- T2 Recon Lag Screw 6.5x100MM--K400122; T2 Recon Lag Screw 6.5x100MM--K454331; T2 Recon Lag Screw 6.5x100MM--K488721; T2 Recon Lag Screw 6.5x100MM--K519501; T2 Recon Lag Screw 6.5x100MM--K519502; T2 Recon Lag Screw 6.5x100MM--K519503; T2 Recon Lag Screw 6.5x100MM--K519504; T2 Recon Lag Screw 6.5x100MM--K519505; T2 Recon Lag Screw 6.5x100MM--K519508; T2 Recon Lag Screw 6.5x100MM--K519509; T2 Recon Lag Screw 6.5x100MM--K678265; T2 Recon Lag Screw 6.5x100MM--K678266; T2 Recon Lag Screw 6.5x100MM--K757955. 18976105S-- T2 Recon Lag Screw 6.5x105MM--K400123; T2 Recon Lag Screw 6.5x105MM--K454332; T2 Recon Lag Screw 6.5x105MM--K488751; T2 Recon Lag Screw 6.5x105MM--K519604; T2 Recon Lag Screw 6.5x105MM--K519605; T2 Recon Lag Screw 6.5x105MM--K519606; T2 Recon Lag Screw 6.5x105MM--K519607; T2 Recon Lag Screw 6.5x105MM--K519608; T2 Recon Lag Screw 6.5x105MM--K519609; T2 Recon Lag Screw 6.5x105MM--K519611; T2 Recon Lag Screw 6.5x105MM--K678267; T2 Recon Lag Screw 6.5x105MM--K678268; T2 Recon Lag Screw 6.5x105MM--K757974. 18976110S-- T2 Recon Lag Screw 6.5x110MM--K400124; T2 Recon Lag Screw 6.5x110MM--K454333; T2 Recon Lag Screw 6.5x110MM--K488758; T2 Recon Lag Screw 6.5x110MM--K519730; T2 Recon Lag Screw 6.5x110MM--K519731; T2 Recon Lag Screw 6.5x110MM--K519736; T2 Recon Lag Screw 6.5x110MM--K678269; T2 Recon Lag Screw 6.5x110MM--K757979. 18976115S-- T2 Recon Lag Screw 6.5x115MM--K400125; T2 Recon Lag Screw 6.5x115MM--K454334; T2 Recon Lag Screw 6.5x115MM--K488759; T2 Recon Lag Screw 6.5x115MM--K497822; T2 Recon Lag Screw 6.5x115MM--K519899; T2 Recon Lag Screw 6.5x115MM--K519900; T2 Recon Lag Screw 6.5x115MM--K519901; T2 Recon Lag Screw 6.5x115MM--K678271; T2 Recon Lag Screw 6.5x115MM--K678293. 18976120S-- T2 Recon Lag Screw 6.5x120MM--K400126; T2 Recon Lag Screw 6.5x120MM--K454335; T2 Recon Lag Screw 6.5x120MM--K520037; T2 Recon Lag Screw 6.5x120MM--K520038; T2 Recon Lag Screw 6.5x120MM--K520039; T2 Recon Lag Screw 6.5x120MM--K678294; T2 Recon Lag Screw 6.5x120MM--K678295; T2 Recon Lag Screw 6.5x120MM--K757980. 18976125S-- T2 Recon Lag Screw 6.5x125MM--K454336; T2 Recon Lag Screw 6.5x125MM--K488786; T2 Recon Lag Screw 6.5x125MM--K520139; T2 Recon Lag Screw 6.5x125MM--K520140; T2 Recon Lag Screw 6.5x125MM--K678296; T2 Recon Lag Screw 6.5x125MM--K678297; T2 Recon Lag Screw 6.5x125MM--K808190. 18976130S-- T2 Recon Lag Screw 6.5x130MM--K454337; T2 Recon Lag Screw 6.5x130MM--K520156; T2 Recon Lag Screw 6.5x130MM--K520157; T2 Recon Lag Screw 6.5x130MM--K520158; T2 Recon Lag Screw 6.5x130MM--K520159; T2 Recon Lag Screw 6.5x130MM--K520160; T2 Recon Lag Screw 6.5x130MM--K678298; T2 Recon Lag Screw 6.5x130MM--K678299; T2 Recon Lag Screw 6.5x130MM--K757982
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 12, 2005.
Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is ongoing.
REASON
The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
VOLUME OF PRODUCT IN COMMERCE
4,698 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Baxter's Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; made in Canada, Recall # Z-0061-06
CODE
All units of software versions 4.0 (66) and 4.1 (77)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 29, 2005.
Manufacturer: Baxter Healthcare Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing.
REASON
If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MO, MA, VT, CA and Canada

_______________________________
PRODUCT
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0, Recall # Z-0064-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Boston Scientific, San Jose, CA, by letters on February 18, 2005 and May 18, 2005. Firm initiated recall is ongoing.
REASON
The device has the potential for overheating its transformer and has the potential for fire hazard.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide, EU and Canada

_______________________________
PRODUCT
a) Remington Medical Ten Disposable Tear-Away Introducer
Sets Size 7 French, Sterile: Single Use/Disposable
Radiopaque Contents Ethylene Oxide Sterilized,
Recall # Z-0065-06;
b) Remington Medical, Ten Disposable Tear-Away Introducer
Sets, Size 8 French, Sterile: Single Use/Disposable
Radiopague Contents Ethylene Oxide Sterilized,
Recall # Z-0066-06;
c) Remington Medical, 8 French-Sheath Only, Size 8
French, Single Use. Ethylene Oxide sterilized;
Recall # Z-0067-06
CODE
a) Lot No. 040508, 041111, 042116, 042367, 043146,
050077, 041464;
b) Lot No. 043003, 042674, 042313;
c) Lot No. 041603, 041731, 050201, 050274
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remington Medical Inc., Alpharetta, GA, by letter starting July 6th through July 11, 2005.
Manufacturer: B. Braum Medical, Inc., Allentown, PA. Firm initiated recall is ongoing.
REASON
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN COMMERCE
4,800 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.), Recall # Z-0068-06
CODE
Serial numbers: 4001-4019
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter, dated August 18, 2005. Firm initiated recall is ongoing.
REASON
The image balance center point correction algorithm used in CT image reconstruction may cause a disappearance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.
VOLUME OF PRODUCT IN COMMERCE
19 devices
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) DTX(tm) Plus DT-DL60 Continuous flush catheter,
Part Number 682028, Recall # Z-0069-06;
b) CRITIFLOW(tm) TA4004 continuous flush catheter,
Part Number 682060, Recall # Z-0070-06;
c) TAKHPQ60R continuous flow catheter, Part Number 682117.
Recall # Z-0071-06;
d) CRITIFLO(tm) TAK0460 continuous flow catheter,
Part number 682118. Recall # Z-0072-06;
e) DT-DL60-1 W/Bifurcated, Part Number 682147,
Recall # Z-0073-06;
f) CRITIFLO(tm) flush kit. Part Number 687198,
Recall # Z-0074-06;
g) CRITIFLO(tm) Flush Kit. Part Number 687566,
Recall # Z-0075-06
CODE
a) Lot numbers: 102034, 103270, 106049, 107034, 108073,
109040, 107034, 110023, 110037, 111023, 203021,
205038, 206055, 207079, 207525, 208110, 208476,
209101, 210095, 211082, 212097, 301139, 301666,
303123, 303616, 305027, 306242, 308059, 309106,
310143, 311160, 312121, 401036, 402022, 403063,
404043, 405079;
b) Lot numbers: 012485, 101226, 102036, 103011, 103370,
106015, 107041, 108033, 109060, 110004, 111037, 201056,
204002, 205041, 206026, 207062, 208073, 211376, 212407,
301104, 302256, 303085, 303246, 304562, 306211, 306443,
308071, 308169, 308518, 309086, 310124, 311143, 312418,
403315, 404050, 405097, 407055, 407468, 408018;
c) Lot numbers 107612, 109012, 110019, 112035, 210060,
212386, 301150;
d) Lot Numbers 402035, 409152;
e) Lot numbers 010019, 102055, 105054, 103029, 106054,
107040, 108079, 109045, 110042, 201072, 203025,
207529, 310143, 310147, 311166, 312127, 401042,
401589, 403069;
f) Lot Numbers 301850, 302267, 303012, 305055;
g) Lot Number 302520
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson Medical Systems, Sandy, UT, by letter on August 22, 2005.
Manufacturer: Bd Critical Care Systems P. L., Singapore. Firm initiated recall is ongoing.
REASON
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
VOLUME OF PRODUCT IN COMMERCE
27,085 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains, Recall # Z-0076-06
CODE
Product code 2179 Lot 520198, exp June 2010; Lot 520200, exp June 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by telephone and e-mail on September 2, 2005.
Manufacturer: Avil Medical Products, Inc., San Diego, CA. Firm initiated recall is ongoing.
REASON
Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
VOLUME OF PRODUCT IN COMMERCE
4,630 units
DISTRIBUTION
Japan

_______________________________
PRODUCT
a) Merit Custom Procedure Kit, Part number:
K08-01894, Recall # Z0077-06;
b) Merit Custom Procedure Kit, Part number:
K09-08347, Recall # Z0078-06;
c) Merit Custom Procedure Kit, Part number:
K09-05248P, Recall # Z0079-06;
d) Merit Custom Procedure Kit, Part number:
K09-05248AP, Recall # Z0080-06;
e) Merit Custom Procedure Kit, Part number:
K09-06702, Recall # Z0081-06
CODE
a) Lot number: A306856;
b) Lot numbers: A304591, A322679;
c) Lot numbers: A304826, A314447, A316544,
A322290, A325742, A336903, A345355;
d) Lot numbers: A348563, A360799, A365773,
A370274, A372525, A377402, A382733, A388638,
F392744;
e) Lot number: C229306
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on September 2, 2005. Firm initiated recall is complete.
REASON
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
VOLUME OF PRODUCT IN COMMERCE
917 kits
DISTRIBUTION
DC, MD, VA, the Netherlands and Switzerland

_______________________________
PRODUCT
a) Medrad Avanta Single Patient Disposable
Sets. Catalog number AVA 500 SPAT,
Recall # Z-0082-06;
b) Medrad Avanta Multi-patient Disposable Sets.
Catalog number AVA 500 MPAT, Recall # Z-0083-06
CODE
a) Lot number 50577, 50578, 51219, 51220,
51221, and 52208;
b) Lot numbers 50627, 50628, 51069, 51070,
51071, and 51747
RECALLING FIRM/MANUFACTURER
Medrad, Inc., Indianola, PA, by letters dated September 20, 2005. Firm initiated recall is ongoing.
REASON
Stress crack on the stopcock.
VOLUME OF PRODUCT IN COMMERCE
2,425 sets
DISTRIBUTION
Nationwide, Netherlands, Denmark, France, and Italy

_______________________________
PRODUCT
Serum Blood Collection Tubes, Recall # Z-0086-06
CODE
Item #455071, Lot #B040513 and
Item #455092, Lot #B040503
RECALLING FIRM/MANUFACTURER
Greiner VACUETTE North America, Monroe, NC, by letter on July 28, 2005. Firm initiated recall is ongoing.
REASON
Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
VOLUME OF PRODUCT IN COMMERCE
1,623 cases (1,947,600 pieces)
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Y-valve, catalog number 7427-01 and T-valve, catalog number 7990-01, PSD/4 with Valve and Syringe Drive Module parts, catalog number 51863-01-IL, Recall # Z-0087-06
CODE
For 7427-01 (Lot number, date of manufacture): 277702, 4/29/2003; 282550A, 8/11/2003; 282550, 8/13/2003; 286630, 10/1/2003; 287449, 10/20/2003; 287137, 10/20/2003; 287949, 12/18/2003; 301809, 6/30/2004; 305599, 8/19/2005; 309328, 11/5/2004; 313276, 12/17/2004; 314662, 3/7/2005; 317940, 4/6/2005; 319506, 4/11/2005; 321121, 5/6/2005; 324204, 6/23/2005; 325483, 7/20/2005. For 7990-01: 277703, 4/30/2003; 283119, 9/30/2003 291279, 1/7/2004; 303942, 7/19/2004; 303687, 7/19/2004; 318833, 3/24/2005; 319684, 5/5/2005
RECALLING FIRM/MANUFACTURER
Hamilton, CO. Reno, NV, by letter and e-mail on August 24, 2005. Firm initiated recall is ongoing.
REASON
The product valve has a high probability of deforming and may result in leakage during use.
VOLUME OF PRODUCT IN COMMERCE
171 Y valves and 30 Y valves were distributed.
DISTRIBUTION
CA. MA. MI, WI, Japan and Switzerland

_______________________________
PRODUCT
Misys Laboratory version 6.1 - Microbiology Module, Recall # Z-0088-06
CODE
All serial numbers for these models
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by telephone, e-mails and Product Safety Notice dated September 29, 2005. Firm initiated recall is ongoing.
REASON
Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
Dual Lumen Cannula, 12Fr., sterile, disposable, Model V V 12F, Recall # Z-0055-06
CODE
Lot number: 36BC20121
RECALLING FIRM/MANUFACTURER
Origen Biomedical, Inc., Austin, TX, by letter on December 16, 2002. Firm initiated recall is complete.
REASON
Leak between two lumens causes reduced performance.
VOLUME OF PRODUCT IN COMMERCE
170 catheters
DISTRIBUTION
Nationwide, United Kingdom, Canada, and Germany

______________________________
PRODUCT
HoverMatt Patient Transfer Solution/Air Transfer Mattress, Model numbers: HM28DC, HM34HS, HM34DC, HM39HS, HM39DC, Recall # z-0084-06
CODE
?????
RECALLING FIRM/MANUFACTURER
D. T. Davis Enterprises, Ltd., Bethlehem, PA, by letters dated October 5, 2005. Firm initiated recall is ongoing.
REASON
Instructions for use are not adhering to the product.
VOLUME OF PRODUCT IN COMMERCE
866 units
DISTRIBUTION
Nationwide, United Kingdom, Canada, and Australia

_______________________________
PRODUCT
Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30”. Model number 933B. The product is shipped in boxes containing 12 units. Recall # Z-0085-06
CODE
Lot number: M732780
RECALLING FIRM/MANUFACTURER
Surgical Specialties Corp, Reading, PA, by fax on September 24, 2005. Firm initiated recall is ongoing.
REASON
Mislabeled as double armed straight needle.
VOLUME OF PRODUCT IN COMMERCE
27 boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
a) Medication Mardel biospheres Maracide
for Ick, Velvet, and other external
Parasites, Contents 2 fl. oz. (59mL)
and Fish Care Guide. Virbac Animal Health.
Active Ingredients: Malachite green,
Chitosan, Recall # V-001-6;
b) Medication Mardel Maroxy for True fungal
infections of fish and eggs. Contents 2 fl.
oz. (59mL) and Fish Care Guide. Virbac
Animal Health. Active Ingredients: Stabilized
chlorine oxides, Recall # V-002-6
CODE
a) Lot number: WE433;
b) Lot number: PF422
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone and letters on September 14, 2005. Firm initiated recall is ongoing.
REASON
Product designed to treat external parasites in fish aquariums was packaged with labeling for another product.
VOLUME OF PRODUCT IN COMMERCE
19,366 units
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR OCTOBER 26, 2005

 

###

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.