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U.S. Department of Health and Human Services

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Enforcement Report for November 23, 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.

November 23, 2005
05-47

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

______________________________
PRODUCT
Little Michael Dried Apricots, ll oz., Recall # F-025-6
CODE
082905
RECALLING FIRM/MANUFACTURER
Aurora Products, Inc., Stanford, CT, by telephone on October 8, 2005 and by press release on October 1, 2005. Firm initiated recall is complete.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NY

_______________________________
PRODUCT
Shurfine brand Butterscotch Twirl Ice Cream in 1/2 gallon cartons, Recall # F-030-6
CODE
Lot number: CB L1 H26-426 05215
RECALLING FIRM/MANUFACTURER
House of Flavors, Inc., Ludington, MI, by press release on August 30, 2005. Firm initiated recall is complete.
REASON
Cartons labeled as Butterscotch Twirl Ice Cream actually contained Peanut Butter Swirl Ice Cream with peanut butter as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
2,406 cartons
DISTRIBUTION
DE
 

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

______________________________
PRODUCT
All Natural 100% Organic Apple Cider, Pasteurized, ½ gallon (1.89L), Recall # F-026-6
CODE
Lot number: 278, Sell By: November 04
RECALLING FIRM/MANUFACTURER
Carlson Orchards, Inc., Harvard, MA, by telephone and email on October 7, 2005. Firm initiated recall is ongoing.
REASON
The firm's private laboratory analysis of the product found that the level of patulin in the product exceeds FDA's action level of 50 ppb.
VOLUME OF PRODUCT IN COMMERCE
278 cases/9-1/2 gallon
DISTRIBUTION
MA
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Micronefrin (racemic epinephrine) Each 100 mL contains racemic methylamino-ethanol catechol 2.25g, For Inhalation Topical Pulmonary Chemotherapy (TPC), Mucosal Decongestant and Bronchodilator, 15 ml and 30 ml bottles, Rx only, Made in U.S.A., NDC 12136-009-11, Recall # D-021-6
CODE
Lot Number 297 Expiration Date 03/05, Lot Number 398 Expiration Date 12/05, Lot Number 399 Expiration Date 06/06, Lot Number 401 Expiration Date 02/07, Lot Number 297 Expiration Date 03/05, Lot Number 398 Expiration Date 12/05, Lot Number 399 Expiration Date 06/06, Lot Number 401 Expiration Date 02/07
RECALLING FIRM/MANUFACTURER
Viasys Respiratory Care, Inc., Palm Springs, CA, by letters dated October 15, 2005. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; product not manufactured sterile as required by the FDA Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation.
VOLUME OF PRODUCT IN COMMERCE
64,517 bottles
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Amino Acid Cervical Cream, ACTIVE INGREDIENTS: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine 0.35%, Net Wt. 2 3/4 Ounce Tube 77.96 Grams & Applicator, Rx only, NDC 60267-234-14, Recall # D-024-6
CODE
Lot numbers: 40803E06/06, 40804E06/06, 41008E07/06, 50524E04/07, 50525E07/07, 50608E04/07 & 50609E04/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hope Medical Enterprises, Inc., Scottsdale, AZ, by telephone and letter dated November 3, 2005.
Manufacturer: Sheffield Laboratories, New London, CT. Firm initiated recall is ongoing.
REASON
Method validation deviations for finished product testing.
VOLUME OF PRODUCT IN COMMERCE
37,514 tubes
DISTRIBUTION
Nationwide and PR

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Oxycodone and Acetaminophen Capsules, USP, 5 mg/500mg Capsules, Rx only, 100 count bottles, Qualitest? brand, NDC 0603-4997-21, Recall # D-022-6
CODE
Lot number: C0821203A
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on October 10, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure (21 month stability)
VOLUME OF PRODUCT IN COMMERCE
2,768 bottles (100 capsules/bottle)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
NeoTect Kit for the preparation of Technetium TC-99m Depreotide Injection, Diagnostic for intravenous use, Single use Vial, Rx only, NDC 45567-0515-3, Recall # D-023-6
CODE
Lot number: 30121 Exp. Date: April 1, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: CIS-US, Inc, Bedford, MA, by telephone on October 19, 2005 and by letter on October 20, 2005.
Manufacturer: Rentschler Biotechnologie Gmbh & Co. KG, Laupheim, Germany. Firm initiated recall is ongoing.
REASON
Exceeds Impurity specification
VOLUME OF PRODUCT IN COMMERCE
73 vials
DISTRIBUTION
Nationwide

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma, Recall # B-0058-6
CODE
Unit number: 40583167
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Muskegon, MI, by facsimile dated July 1, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor who had been permanently deferred due to drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0085-6
CODE
Unit number: 6577083
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 3, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with the manufacturer's instructions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0089-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0090-6;
c) Platelets, Recall # B-0091-6;
d) Recovered Plasma, Recall # B-0092-6
CODE
a) Unit numbers: 13FN51729 and 13FN56751;
b) Unit number: 13GV09117;
c) and d) Unit numbers: 13FN51729, 13FN56751
and 13GV09117
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone or electronic mail on March 31, 2005 and by letter dated April 8, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reported close contact with someone with a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, MI, and PR

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0114-6
CODE
Unit number: 10194-9490
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by Telephone on April 6, 2005. Firm initiated recall is complete.
REASON
Blood product, for which the dual pheresis unit was found to be hemolyzed, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes
Reduced, Recall # B-0115-6;
b) Red Blood Cells Leukocytes Reduced,
Recall # B-0116-6
CODE
a) Unit numbers: 101894646, 101891164,
101882852, 101900353, 101899040;
b) Unit numbers: 307426363, 247492303,
101911143
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on February 24, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not evaluated when associated split units were returned due to possible hemolysis, were distributed
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Medical Devices -- Recall # B-0122-6:
a) Medtronic One Source Pack;
Medtronic Ideal Maxpac Total System
CODE
a) Model BT711EM;
b) Model TS8285R and TS8285R2
RECALLING FIRM/MANUFACTURER
Medtronic Perfusion Systems, Brooklyn Park, MN, by letter dated February 10, 2005. Firm initiated recall is complete.
REASON
Medical devices, assembled with recalled blood transfer bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,325 devices
DISTRIBUTION
AL and OR

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0128-6
CODE
Unit number: 7065528
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 4, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received acupuncture within twelve months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Source Plasma, Recall # B-0159-6
CODE
Unit numbers: 6270288132, 6270285132, 6270282958, and 6270280365
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. South Salt Lake City, UT, by facsimile on January 7, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was not adequately assessed for risk factors for variant Creutzfeldt-Jakob Disease (VCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0160-6;
b) Recovered Plasma, Recall # B-0161-6
CODE
a) and b) Unit number: 6134003
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September 23, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the confidentiality of the donor screening process was compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0162-6
CODE
Unit number: 320006
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated February 10, 1998. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0164-6
CODE
Unit numbers: 576166, 327673, 332511, 327670, 320556, and 325996
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated March 16, 1998. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0167-6
CODE
Unit number: 6376729
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on May 4,2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that possibly compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Source Plasma, Recall # B-0168-6
CODE
Unit numbers: 0348295, 0348725, 0349250, 0350117, 0350780, 0351277, 0351789, 0352539, and 0352936
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by electronic mail on July 23, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo and body piercing within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
United Kingdom

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0171-6;
b) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0172-6
CODE
a) Unit numbers: 2239344, 2478382, 2478435,
2478933, 2478947, 2479566, 2479982, 3922519,
3923974, 3923990, 3924276, 3924914, 5564897,
5564904, 5564911, 5851572, 5851585, 5852269,
5852270, 5852278, 5852286, 5852320, 5853133,
5853140, 5853149, 5853151, 5853181, 5853183,
5853186, 5853209, 5853214, 5853217, 5934531,
5934537, 5934556, 6158148, 6158156, 6158176,
6158293, 6158298, 6158304, 6158705, 6158712,
6253972, 6335940, 6336068, 6336074, 6336332,
7960439, 9207581, 9594803, 9594817, 2239344,
2239720, 2478382, 2478409, 2478933, 2479566,
2479982, 3922519, 3923974, 3923990, 3924276,
3924914, 3924922, 5564897, 5564904, 5564911,
5851572, 5851585, 5852269, 5852270, 5852278,
5852286, 5852320, 5853133, 5853140, 5853149,
5853151, 5853181, 5853183, 5853186, 5853209,
5853214, 5853217, 5934531, 5934556, 6158148,
6158176, 6158293, 6158298, 6158304, 6158705,
6158712, 6253972, 6335620, 6335940, 6336068,
6336074, 6336332, 6336339, 7960439, 9207581,
9594803, 9594817
b) Unit numbers: 2478435, 2478947, 5934537,
9207599, 2239720, 2478409, 3924922, 6335620,
6336339, 9207599
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone and facsimile dated June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0175-6
CODE
Unit number: 12W96270
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on September 30, 2004. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0181-6
CODE
Unit numbers: H73745 (split unit)
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0191-6
CODE
Unit number: 7058743
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0192-6
CODE
Unit numbers: 7672590, 7671775
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on September 15, 2004. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0193-6
CODE
Unit numbers: 7243299, 7243374, 3766110
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on March 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY and TX

_______________________________
PRODUCT
Platelets, Recall # B-0194-6
CODE
Unit number: X27249
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on December 29, 2004 and by letter dated January 3, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0195-6;
b) Recovered Plasma, Recall # B-0196-6
CODE
a) and b) Unit number: 6492916
RECALLING FIRM/MANUFACTURER
Community Blood Bank, Inc., Rancho Mirage, CA, by facsimile on April 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and FL

_______________________________
PRODUCT
Red Blood Cells Pheresis, Recall # B-0197-6
CODE
Unit numbers: 4701671 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on March 23, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0200-6;
b) Fresh Frozen Plasma, Recall # B-0201-6
CODE
a) and b) Unit number: 20Q01346
RECALLING FIRM/MANUFACTURER
American National Red Cross, Salt Lake City, UT, by telephone on March 12, 1999 and March 22, 1999. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0202-6;
b) Fresh Frozen Plasma, Recall # B-0203-6
CODE
a) and b) Unit number: 0685687
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and by letter dated August 26, 2003. 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
CA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0204-6
CODE
Unit number: Y00593
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on December 2, 2004. Firm initiated recall is complete.
REASON
Blood Product, which was collected from an unsuitable donor based on risk factors for Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0210-6
CODE
Unit number: 33FP49389 (part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on July 15, 2005 and by letter dated July 27, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus capitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CT

_______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0211-6;
b) Plasma, Cryoprecipitate Reduced,
Recall # B-0212-6;
c) Cryoprecipitated AHF, Recall # B-0213-6
CODE
a) Unit numbers: 20LC59938, 20T40482;
b) and c) Unit number: 20S52399
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone and letter dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AZ, CA, and ID

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0218-6
CODE
Unit number: 18237-5645
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone or facsimile on May 27, 2005.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WY

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0229-6
CODE
Unit number: 1882568
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by fax on May 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-0231-6
CODE
Unit number: 04FV39993
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and letter on July 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-0232-6
CODE
Unit numbers: 04FK62209, 04FR91414
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and letter on July 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0234-6
CODE
Unit number: 7836225
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter dated October 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0271-6
CODE
Unit number: 2291251
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on February 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
FL

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0163-6
CODE
Unit numbers: 216416, 216426, 217686, and 221020
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on December 31, 1996. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0165-6
CODE
Unit number: 6970056
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on June 2, 2002. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0166-6
CODE
Unit number: 6520472
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on August 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not properly tested for syphilise, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0170-6
CODE
Unit numbers: 108LJ35032 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by telephone and letter dated May 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-0173-6;
b) Red Blood Cells, Recall # B-0174-6
CODE
a) Unit numbers: 7004332, 6147133, 7004333, 7004329,
6147126, 6146856, 7004311, 6146848;
b) Unit number: 6147203
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated August 5, 2002. Firm initiated recall is complete.
REASON
Red Cells, invalidated due to a NAT testing error, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0176-6
CODE
Unit number: 6174296
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated February 19, 2003. Firm initiated recall is complete.
REASON
Red Blood Cells, incorrectly tested for HIV/HCV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0177-6
CODE
Unit numbers: 8500750, 8500733
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Ventura, CA, by telephone on December 27, 2004. Firm initiated recall is complete.
REASON
Red Cells, leukoreduced by filtration greater than five days post collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0178-6
CODE
Unit number K80698
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated April 18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0179-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0180-6
CODE
a) and b) Unit number: X22856
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which were labeled leukoreduced, but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0182-6
CODE
Unit number: 6445597 (Part 1)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL , by telephone on August 18, 2005.
Manufacturer: LifeSource, Skokie, IL. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Source Plasma, Recall # B-0217-6
CODE
Unit number: VA-138504
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp., Van Nuys, CA, by letter dated December 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0219-6
CODE
Unit number: 18237-5645
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone or facsimile on May 27, 2005.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0221-6
CODE
Unit number: 17FX30081
RECALLING FIRM/MANUFACTURER
American National Red Cross, Salt Lake City, UT, on February 7, 2000. Firm initiated recall is complete.
REASON
Blood product, which was exposed to unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0227-6
CODE
Unit numbers: 06FE71888, 06FE71890, 06FE71918
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on April 5, 2004 and by letter dated April 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Recall # Z-0130-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated February 10, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing.
REASON
Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
VOLUME OF PRODUCT IN COMMERCE
24,009 pumps
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits). Recall # Z-0140-06
CODE
Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone on July 26, 2005 and by letter dated July 28, 2005.
Manufacturer: Terumo Cardiovascular Systems Corp., Ashland, MA. Firm initiated recall is ongoing.
REASON
Small cracks in the blood chamber may allow air to enter the rotor of the device.
VOLUME OF PRODUCT IN COMMERCE
893 kits
DISTRIBUTION
AZ, CA, KY, IL, LA, MD, WA, and WI

_______________________________
PRODUCT
a) D-Stat Dry Hemostatic Bandage, model number 3000.
Sterile, latex free single use device. Vascular.
Each D-Stat Dry hemostatic bandage (D-Stat Dry)
consists of the following components: -Lyophilized
pad consisting of thrombin, sodium
carboxylmethyulcellulose and calcium chloride in a
nonwoven gauze; -Adhesive bandage, Recall # Z-0142-06;
b) D-Stat Hemostat Band, model number 3500. Sterile,
latex free single use device. Each D-Stat Radial
hemostatic band (D-Stat Radial) consists of the
following components: -Lyophilized pad consisting
of thrombin, sodium carboxylmethyulcellulose and
calcium chloride in a nonwoven gauze; -Application
device consisting of an adjustable retention strap,
collar and attached gauze pad, Recall # Z-0143-06;
c) D-Stat 2 Dry Hemostatic Bandage, model number 3010.
Sterile, latex free single use device. Each D-Stat
2 Dry hemostatic bandage (D-Stat 2 Dry) consists of
the following components: -One (1) scored lyophilized
pad consisting of thrombin, sodium
carboxylmethyulcellulose and calcium chloride;
-Two (2) Adhesive bandages. Recall # Z-0144-06
CODE
a) 301322, 301323, 301359, 301323A, 301393 and 301360;
b) 301384, 301385 and 301386;
c) 301404
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Osseo, MN, by letter dated September 9, 2005 and by Sales Representative visit beginning September 19, 2005. Firm initiated recall is ongoing.
REASON
A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.
VOLUME OF PRODUCT IN COMMERCE
9,775
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Implantable Cardioverter Defibrillators:
Photo DR, Model V-230HV, Recall # Z-0146-06;
b) Photo Micro VR/DR, Models V-194,
Recall # Z-0147-06;
c) Photo Micro VR/DR, Models V-232,
Recall # Z-0148-06;
d) Atlas VR, Models V-199, Recall # Z-0149-06;
e) Atlas DR, Model V-240, Recall # Z-0150-06;
CODE
a) Serial Numbers: 30135 29709 30851 30872 32679 29370 28655 30440 31489 30258 28451 29030 28244 28786 29258 29993 31012 31031 31135 32003 32384 32419 33123 30156 29706 31918 31545 32230 30302 30691 28564 28693 28277 28982 29219 30483 11333 28660 30485 30558 30632 28563 29702 30947 30153 33000 30140 29133 30246 31978 32275 33074 40008 30511 32157 28114 30146 28025 29341 35040 31108 32148 32161 32687 33016 33087 35032 30524 31960 33088 32118 32702 28170 28595 28611 30167 31498 31523 33049 30372 32715 28703 31126 28124 29658 28754 29654 31225 29192 32513 28343 29726 30897 30900 31293 31441 31992 35039 30848 29061 32804 28208 29643 29936 29960 30373 30392 30571 30610 31904 32100 30896 31036 31190 31584 31870 28640 32252 29317 29545 31517 29562 28483 28729 30137 29716 31553 29295 29637 29765 29931 30371 30477 30776 30834 32798 32978 31818 30126 35061 29017 32639 29167 29552 31295 32069 28878 29410 28682 32786 28552 30266 31912 30425 28458 29189 31274 32494 32851 28419 28433 32686 30163 28080 30364 31154 28148 28522 29796 30710 31372 29627 29399 31536 32836 31989 29345 29648 29664 29850 29677 30161 32120 32603 28597 30491 29090 30220 30476 30493 33103 11301 28716 28818 29103 29340 29632 30731 32646 28372 29452 31420 28507 28286 28088 32378 32949 29969 28059 29100 29269 30857 24297 29134 30671 33028 35055 32177 28737 32601 29790 30523 30880 29297 31371 28765 28001 29263 29424 31943 31979 28767 29303 29944 30283 30395 30448 30636 32212 29179 29142 29538 30197 30784 30132 32490 35045 35060 30751 28739 29939 30282 32012 30526 33188 28476 35080 29222 29386 29400 32246 32255 32852 28355 28920 29793 30185 30964 31493 31519 32021 32706 28883 30787 31174 31507 30688 35095 29245 32248 32429 30455 30700 30712 32182 32539 32097 28602 28300 29588 30975 30357 28813 35077 28924 30278 28287 28407 30971 29707 32862 32965 32249 30914 31183 30127 32056 32967 40076 30277 31389 29780 30409 31297 31461 28110 28175 28495 28772 29298 29320 31591 31920 29139 28929 28608 31321 28251 29327 32053 29668 29692 30038 31867 30193 32881 28757 31286 32481 28571 30867 28596 29113 29065 29068 28482 30464 11325 28828 30285 30676 30894 31122 31360 31482 31535 31541 31919 32695 33008 33132 35029 35106 11242 28234 28299 28398 29323 32390 28514 32537 30215 29231 28659 28807 28079 32878 28892 28417 31993 31058 29212 30240 28426 31115 31155 32449 32703 32899 33040 30998 28271 29122 30061 35063 28115 28215 28995 29659 30007 30101 30355 31302 32472 32647 33026 31599 30908 31393 33108 31875 33029 32704 28026 28775 30850 32121 33107 30759 29816 28272 28628 30019 31165 28804 30190 30556 32239 32585 28726 29758 30347 30471 31940 35066 29564 29704 29811 29900 30421 30489 32438 32648 32656 32699 35030 35070 40009 28104 30486 29943 31456 31187 28127 28383 29495 29872 29926 30017 30233 30380 30472 30818 28146 29084 29116 24172 29411 32470 29124 28894 28902 28763 29493 30259 32613 30232 31310 11378 24086 29232 29671 30666 32036 31325;
b) Serial Numbers: 46628 43164 43242 43249 44422 44481 44491 44895 45054 46627 46665 46677 46784 46873 46952 46958 46983 48007 48019 48140 48146 48228 48265 48430 48454 51505 40032 39656 42064 47989 42617 46506 47944 42113 42048 44113 44190 51183 44501 45102 46716 51500 40045 48004 43240 42429 43036 43094 43296 43380 45028 45094 45909 46521 46672 46796 42167 48030 43070 43204 43220 42374 44460 46045 46604 46762 46875 48481 39959 39960 48371 42105 44158 43387 44198 42418 46061 46695 39582 46731 51164 51187 51246 51694 51738 42201 42853 43285 44145 48336 48397 51537 51719 42051 42839 43202 44417 43051 44889 40181 43304 43342 39987 45916 45072 43272 40158 42075 44836 42108 51245 51879 42860 44505 46102 46070 45055 44879 42308 46937 42052 42290 42112 42176 42183 42188 42264 42301 42822 45097 45817 46722 46885 47132 47693 47822 48451 40284 39521 39524 43079 43398 44202 44432 47925 48262 40135 39631 42087 42091 39989 46967 44173 48629 42225 46942 47062 47075 47935 51192 51650 39963 39651 42069 39709 45864 46636 44193 47623 40033 43093 43134 44194 46014 46042 48047 39545 40805 39649 44504 48205 48271 48288 43236 42332 42803 42901 43031 44135 44152 46021 47000 48301 46666 42425 42636 47976 48375 39648 42878 43064 45080 45875 40826 42157 42447 47634 47691 40165 42039 45051 43077 43080 48141 42400 42630 48620 45941 45959 46087 47633 47700 47952 47978 47995 48110 48315 48418 48461 48526 51166 51172 51244 51662 51688 40005 46593 43311 47909 43174 42224 42859 43106 46805 46840 46898 47392 47912 48291 48402 51224 51704 43076 43087 47059 48048 48006 47826 51227 43213 42366 42389 47607 47997 40258 43245 42296 42832 45877 48573 40838 41106 42269 42674 47673 46007 42637 45965 39561 43230 48604 46687 46689 48169 42314 43017 46970 46564 44431 43112 51737 40845 43146 43153 43192 42402 42446 42656 43023 43048 43057 43131 43327 43378 44162 44461 44500 45992 47393 47903 47904 47993 48027 48151 48363 48395 39529 40136 40140 40253 40278 40300 39627 51670 46662 44831 44415 43169 44496 47631 46589 48120 40102 43269 42319 44131 44185 48567 46887 47068 48313 39986 39995 40013 39624 42210 42671 42850 43098 45056 48583 46024 46516 46569 46749 46788 46904 46988 47098 47684 47824 47996 48144 48222 39979 39997 40015 43225 42135 42160 42166 42229 42432 43347 44150 44205 44881 45887 48561 48613 48650 46093 46759 46781 46856 46891 47654 47958 48249 39743 39977 40101 39607 40137 40161 40810 42100 46772 46799 39952 39969 40276 42872 46848 51742 40036 40295 42431 42613 42904 48537 46065 46709 47108 47376 44137 46950 46957 39721 42622 43382 46049 46100 48089 48184 45923 42867 45034 48595 48087 48423 43330 45093 46010 46057 47933 48306 51208 51726 40825 42107 45046 46648 47613 43179 43113 43346 44174 44176 44848 44890 46046 46797 46872 46934 47399 47962 48466 39958 39961 39994 40265 39966 45045 46081 46538 46600 47622 48043 48311 48439 39726 40023 39600 46750 39725 43162 42287 44446 47608 48021 42089 39703 42173 43232 42138 42334 42372 42854 43028 43054 43334 44117 44139 44474 44495 45915 48586 46543 46787 47831 47924 48055 40144 42054 44155 46748 40801 43290 43403 42119 42156 44489 46711 40286 46078 43226 42165 42335 42634 42657 42897 43397 44175 44819 44851 45026 45071 48560 48570 46530 46691 46758 46827 46867 47642 47675 47902 48167 48199 48200 48201 51182 51698 51716 40037 39625 43318 48093 40149 42041 42240 42276 42311 42440 44167 44818 46671 40846 42067 42154 42194 42196 42227 42299 42303 42318 42330 42607 43020 43102 45063 46508 46927 39985 40007 40271 39619 39640 40843 42068 42077 39675 39676 43105 46945 40833 42084 43182 43218 42661 43116 43255 44184 44416 44886 48571 48611 46656 47145 47394 47653 47664 48129 48494 51168 51683 51740 42092 45042 42222 42414 40824 47384 43168 47818 42215 48192 44195 48024 51212 39515 43208 42125 42180 42633 44476 39744 40159 46605 42263 42415 44830 42172 42889 43123 44888 46518 47129 47149 47703 47937 48092 39993 40043 42059 46088 43100 43359 46834 39663 42642 47398 42898 42804 44114 43317 46573 42278 43336 46566 43289 47852 40028 39606 43175 46634 47651 48105 42104 42195 42371 43011 43283 43329 44142 44470 46027 46104 46581 46649 46918 46920 46960 46994 47110 47614 47699 47880 48247 39974 40162 40167 40817 42063 42080 42255 44107 45924 46072 46646 51621 39528 39683 46987 48577 46754 48427 51715 40010 43198 42221 46011 46841 48350 51608 44435 46086 46798 48393 42106 42300 42430 43266 46611 51525 42140 42614 44502 46702 48337 48490 53257 40171 40184 40816 40840 53405 46620 42407 43027 44166 44492 44876 48542 48646 46051 46793 46917 46919 47077 47097 47106 47843 47874 47905 48104 51209 51625 51686 53530 53658 53675 42294 43278 42816 46025 42109 46974 42057 42302 43097 46725 48238 40002 40176 48075 48279 48511 48588 45865 47913 40034 39615 42250 48406 44421 43152 42186 44436 45842 48619 46598 47140 48195 48290 39962 39579 42436 46099 43071 45065 46826 43247 42199 42316 42320 42427 43103 43349 43395 44130 44456 44467 48582 47832 47919 48044 48077 48178 48256 51170 51515 43186 43303 44482 44490 46549 46907 47819 48399 51205 51494 51700 42673 42244 42275 42417 47378 42074 42646 43058 46792 43371 46523 42645 47114 47400 48085 48447 41140 42660 45834 46603 46743 47066 47965 48013 46896 47891 48133 48161 48412 47879 40148 43035 43265 51201 51607 42808 42050 42110 42237 43263 43316 43319 45021 46054 46610 46632 46832 47621 47918 47981 48186 48465 51175 51488 51518 51622 43199 42121 47390 47963 51718 44154 43150 42279 44165 51521 48304 51739 45955 46577 47837 48162 39964 48107 43219 42254 45048 45925 46077 46531 46820 46993 47134 47813 47820 47845 47984 48165 39534 40012 40113 39592 40143 40146 40848 39668 42638 46622 42283 42339 46522 47078 39972 39608 48607 43211 42159 42200 46943 47690 47692 48011 48172 39637 42621 45855 42833 42894 43252 44123 47153 42153 45961 42667 46568 40200 42219 43125 44440 44812 45015 50011 45987 46026 46033 46520 46596 46613 46717 46795 46812 46828 47867 47876 47941 48180 48218 48287 48303 48351 48518 51204 51250 51677 40190 43073 48207 43037 46585 43364 40836 42365 42877 39614 45889 46091 47005 47892 48245 48504 39749 40131 43030 46760 51197 51534 40109 43258 48618 47151 47660 48020 48081 48458 39739 45825 47900 47947 42448 42309 43147 44457 48126 43177 42347 43056 43312 43401 45081 46567 46644 46653 46719 46836 46894 45848 43250 46815 47144 42118 42162 43331 43350 45061 46741 47104 51664 39671 42368 47890 39690 44471 44813 46067 47083 47829 47866 47991 48157 51226 39548 39603 40277 44893 47109 47123 39504 43167 43246 42116 42130 42136 42202 42213 42216 42821 42829 42881 42884 43072 43115 43341 43354 43392 44197 45032 45910 45971 45985 46004 46023 46064 46571 46614 46619 46659 46663 46715 46757 46813 46822 46843 46883 46888 46978 47081 47085 47095 47099 47135 47143 47147 47148 47362 47379 47383 47388 47397 47656 47894 47922 47945 48103 48108 48112 48137 48219 48340 39547 39970 39971 39558 39588 39613 39629 39644 42037 42071 42086 39694 42131 46756 46921 47814 46560 46773 43191 47357 47609 47887 42437 47119 44437 39666 42253 46732 47370 42247 42358 44201 45058 46038 46720 48499 51185 51199 40186 42349 42843 44187 45016 46092 47698 47861 47957 43178 42292 42352 42387 42449 42653 42812 42855 43276 43301 43309 43370 44108 44465 46016 46540 46562 46651 48029 48052 48159 48171 48189 48483 48497 48500 40287 39636 48647 39502 42248 44134 44192 44826 44850 44887 48566 46029 46043 46044 46684 46692 46699 46706 46783 46803 46821 46833 46961 47686 47689 47908 48041 48080 48230 48264 48266 48369 48389 48476 48510 40262 40272 40280 40821 43012 44866 45918 45891 46708 43042 43377 43032 42820 43273 43373 44849 46063 46080 46655 48012 48097 40134 44442 48214 44106 48472 42390 42847 44122 45033 45059 45882 46630 47103 47133 47863 48168 48416 40188 40830 43114 40047 45010 51177 51516 40157 39617 40831 43241 42205 42262 42313 42336 42403 42612 43034 43122 43323 44852 44854 45020 45810 48536 46667 46745 46916 46954 47380 47403 47842 48155 48206 48284 48356 48383 48471 48495 51202 51508 51604 40017 44178 39554 45993 42151 43041 43089 43099 46079 46637 46876 47072 47948 47971 48280 48455 51179 51252 51497 51536 51611 51615 51644 51655 51678 51733 39957 42838 47361 47070 42126 42169 42236 42261 42639 43050 43368 44118 45012 45851 45860 45902 46018 46511 46529 46674 46779 46863 46890 46955 46975 47058 47088 47107 47405 47840 48073 51598 39984 39998 39563 40155 44149 42193 42228 42242 42282 42344 42351 42360 42423 42640 42848 43007 43024 43062 43092 43394 44124 44140 44191 45006 45839 45841 48554 46535 46586 46594 46631 46643 46661 46858 46865 46869 46938 46995 48261 39723 39748 40020 39578 42096 42099 43043 43201 44157 47917 39698 43396 43235 42864 43295 39740 44141 42197 42230 42815 44172 46076 47859 42049 39704 43160 42811 48575 46032 46037 46640 46668 46739 48293 42128 43068 44182 44188 46624 43163 42284 42672 43270 44170 48626 48649 46877 47057 47090 47137 47671 48342 48347 48408 48448 48469 48475 51237 51526 51609 51696 53460 40282 42873 43065 43110 44448 44494 45085 48632 46647 46842 47063 51602 51722 43231 46881 47827 46835 48278 51214 43074 44488 42381 44426 44498 44840 45862 46517 46884 46977 48135 43207 43260 46850 48090 48285 40178 39513 43221 42245 42265 42376 42391 42604 42818 42856 42882 43259 43324 43374 44859 45104 46030 46638 47635 47639 48022 48025 48322 48381 48515 39537 40046 40819 39662 39674 39702 43171 43205 43206 42327 42369 42401 42655 42814 42870 42891 43383 43405 44156 44406 44466 45883 48591 48628 46031 46642 46802 46878 46886 46914 47625 47862 48053 48153 48316 48368 48373 48400 48419 48487 51167 51242 51506 51679 51680 40103 40120 40197 42095 43109 43271 45011 46582 46746 47676 47847 47942 43305 42805 47812 48486 41116 43006 46097 45018 46616 48319 46591 43136 42132 42164 42174 42184 42239 42270 42277 42293 42321 42353 42382 42409 42628 42834 42876 43120 44171 44200 44485 44503 45036 45074 46022 46103 46544 46683 46697 46747 46774 46811 46814 46851 46902 46912 46936 46968 47364 47624 47666 47828 47858 47923 47929 48066 48204 48224 48246 48294 48297 48394 48456 40019 40814 39630 39642 42046 42058 46764 47980 43140 42840 42851 44115 44816 46761 46819 46861 47823 48160 48187 39682 39687 42809 42852 44136 45025 47146 39643 43222 42134 42178 43253 43337 46899 46944 47932 47977 48100 48191 48244 48308 48514 48253 46782 42288 45007 39569 42182 46790 43195 42601 44443 47089 47138 42062 39706 40291 43243 43384 44163 44164 44445 44473 44904 46058 46606 51709 45935 46901 43009 42875 48166 39734 42895 43224 39575 42218 43325 44825 44829 48636 48644 46554 46580 46935 47647 51178 51503 51533 39738 42354 45068 47076;
c) Serial Numbers: 42492 44229 45002 51453 45767 47600 43623 45342 45559 45692 45751 46219 47329 47495 50424 50463 47479 47317 48702 42713 42717 42906 46372 47212 42971 43776 44086 44266 45736 45784 46450 44037 45242 45245 50300 50362 43593 44385 47755 39802 45286 40222 40700 42923 42956 42957 42983 43001 43429 43469 43617 43826 44077 44241 44296 44346 44684 44698 44794 44962 45136 45310 45314 45338 45390 45395 45403 45498 45561 45599 45603 45770 45800 46312 46416 46425 46436 46446 46465 46470 47311 47433 47500 47504 47727 47756 47797 47325 44696 45194 45294 47768 47708 47780 45730 40543 43615 44692 44725 50681 50740 48657 46128 45507 45308 84668 84675 43760 39760 40943 43594 44710 44778 44996 45589 40620 39790 44924 45474 45520 45759 47712 47746 51798 40742 40994 42560 43458 43578 43906 44374 45210 45290 45355 45489 45515 45617 45655 45667 50768 45343 43576 45362 44682 45568 39752 40997 42677 43729 43869 44608 46226 46423 48670 53592 39763 39876 40609 42528 43534 43584 43677 43890 43916 44514 45298 45341 45350 45457 45529 45626 45704 46386 46408 47319 47583 47721 50275 50293 50754 51325 43745 44278 45479 44995 47318 43720 45705 45804 47498 41025 42941 44774 44968 45281 45297 45501 45545 45606 45647 47226 51323 47223 43942 40961 40248 43600 43618 44051 45139 45533 47187 47336 47420 47571 43412 44230 44671 45224 45408 45452 47771 43492 43841 43889 44356 45720 47476 45668 42579 43631 47215 42558 40937 43735 43440 44926 47719 50307 43959 45431 44102 47178 40547 45508 40866 42562 43855 44221 47333 47414 40958 43501 43914 45190 44946 45228 44065 42683 39862 42549 43912 50277 45187 45404 42703 43823 50527 47473 39806 39944 42954 43421 43424 43482 44009 44012 44364 44386 44940 44987 45511 45754 45121 43704 44368 42599 45156 45615 47734 42573 44928 45562 45622 44967 45610 47448 50132 42929 44303 44576 45513 50603 45788 47601 44943 45142 45793 40506 42977 44049 44375 44666 46432 47487 43821 45763 46405 50408 50462 45154 40249 42526 42533 43563 43581 43606 43668 43693 43872 43944 44208 45191 45274 45317 45378 45486 45487 45547 45716 45719 45795 46399 46428 47775 48667 50669 50775 50798 51451 42504 42686 43507 43525 43552 47492 48696 51410 44779 45113 45391 45437 44057 42679 40851 46500 50805 42922 43459 43559 43575 45478 45787 43614 44071 40202 43432 44223 44243 44286 44758 43938 44304 45257 50758 42031 47190 44724 43503 43660 43902 43930 43956 44371 50703 45650 42959 43882 44294 45144 45664 39791 40546 40589 42509 42563 42704 43426 43601 43625 43783 44000 44101 44251 45335 45451 45492 45565 45594 45753 45790 46448 47353 47446 47490 47501 47572 47758 43682 50728 43703 43654 44336 39774 43465 44397 44913 45762 47799 43690 45496 43409 43456 43808 45631 45676 46109 46474 47221 43616 43753 43847 43932 44274 44655 45246 45491 45649 45785 46150 47569 47573 47578 47585 47592 47604 47766 50381 44760 50637 50708 50721 44381 45249 45521 50810 39871 40758 41083 42568 44578 45264 45453 45659 45666 46377 46427 47432 44784 45558 46419 47314 42484 47315 42921 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75335 75784 75788 75807 75994 76834 76847 77462 77640 77815 78758 78771 79156 79194 79705 79953 79963 80062 82343 82363 82498 82857 73808 63944 75350 76200 76267 77119 77262 77290 78523 79977 80401 82298 82306 82341 82347 82352 82362 83556 83570 83574 83578 83580 83784 75842 78972 55539 55877 56348 56526 57089 57631 57659 57815 57890 58040 58604 59015 60378 60645 61343 61357 61788 62199 62220 62230 63168 63538 64140 64658 64875 70431 70684 72044 72883 72952 73009 73016 73335 73512 73770 73788 74292 74800 75321 75583 75626 76056 76209 77271 77632 77896 78437 78993 79967 80011 80019 73778 63184 78748 55682 55840 56139 56356 56892 59022 61297 62228 63161 63169 63942 64281 64690 71490 71580 71591 71812 72039 73488 74077 74338 74412 74431 75331 75339 75344 75588 75804 76004 76229 76290 76332 77128 77305 77479 77483 78443 78470 78759 78807 79192 79696 80704 80738 80745 80953 81373 81746 82310 82340 82350 82355 82357 82365 82530 83281 83288 83290 83559 83560 83568 84004 64901 55401 57627 58595 59296 62027 64775 72996 74785 76673 83752 82515 55375 57393 59066 72700 75324 58241 58680 59901 64475 64725 70326 71229 72930 74760 74801 56701 61554 64447 55077 55545 55658 61816 60993 61355 70300 71267 72628 72649 72679 76383 80085 55988 57419 58042 61676 62785 64002 64466 76035 56350 55505 56016 56195 56713 57363 57664 57778 57859 57929 59105 60392 61010 63020 63176 64237 65386 57113 65474 65532 55187 55846 56354 56417 57884 58039 60552 60584 60908 63007 63023 63028 63337 71239 77860 80723 56136 56467 56877 57410 57849 57958 59751 60357 61072 61300 61367 61515 61697 61719 61996 62023 62169 62440 62458 62755 62811 62815 63019 63022 63425 63427 63524 63714 64214 64500 64654 64663 64708 73298 74451 74741 74767 76366 79966 79979 81696 83312 83321 83571 83766 83779 83781 82441 55048 55369 55760 56191 56920 57066 57074 57820 57922 58733 58758 59054 59724 60063 60079 60090 60544 60572 61045 61077 61500 61543 61681 62030 62154 62763 62823 62960 62967 63335 63459 63523 63891 64728 64796 64797 65350 65356 65490 71223 71553 71594 72674 72855 72905 73035 74389 75273 75372 75564 75820 76059 76206 77101 77595 77820 77828 77830 77870 78436 78466 78752 78785 78792 79146 79157 79209 79630 79685 79951 80055 80416 80629 80706 80979 80986 81344 81356 81372 81394 80475 82447 56333 63947 70433 71474 71765 71786 71799 74469 76005 76054 76258 76828 76856 77140 77149 65207 55169 56381 56496 56665 56721 56779 56872 56908 57044 57059 57084 57844 58698 59679 59958 60366 60535 60649 60923 60940 61008 61047 61079 61732 61815 61841 62163 62166 62203 62205 62216 62367 63018 63197 63888 64005 64248 64474 64499 64692 65136 65183 65198 65202 65383 65460 65502 65508 65569 70206 70246 70308 70324 71209 71468 71573 71581 71746 72030 72707 72712 72865 72866 72871 72971 73015 74031 74299 74308 74312 74424 74769 74805 75125 75294 75301 75358 75377 75568 75605 75816 76019 76371 76577 76592 76611 76859 77102 77494 77508 77610 77803 77807 77812 77872 77895 79644 79659 79670 79689 79713 80387 80395 80399 80430 80448 80473 80616 80851 80964 80966 80968 80991 81375 81390 81695 81737 81753 81780 82326 82328 82354 82360 83322 83335 59953 70748 72487 75048 75108 77285 77320 77337 77677 79662 79677 80377 80394 80445 80449 81720 81740 82287 82297 57358 76049 56840 56770 77284 82364 55743 55554 55707 56190 57350 57874 59286 59303 59738 60095 60576 60648 60957 61535 61797 63000 63031 63884 63926 64134 64173 64288 64808 65139 65186 65395 70282 70328 70547 70715 71248 71570 71932 72250 72297 72858 74331 75090 75120 75121 75316 76848 77279 77821 77867 77900 79183 79188 79668 80480 80484 80611 80625 81377 81702 82372 83589 65352 55043 60075 64131 55865 56864 57625 58624 60513 60718 76225 82351 82848 64495 72510 72652 72709 81386 81604 55044 55076 55165 55655 56132 56150 56505 56511 56528 56874 56896 57666 57732 57748 57931 58269 58284 58440 58688 58701 58748 58750 59674 60139 60355 60370 60492 60587 60972 61038 61052 61067 61369 61560 61784 61805 61813 62774 62945 63054 63848 63880 63931 63968 64653 64707 65210 65358 70254 70759 71031 71400 71401 71456 71593 71768 72049 72293 72629 72630 72636 72671 73314 73402 73463 73503 73521 73527 74064 74296 74345 74419 74747 75052 75072 75269 75299 76026 76028 76048 76213 76264 76800 76846 76875 77153 77597 77663 77670 78749 78974 78984 78992 80045 80049 80056 80462 80478 80686 80691 80693 81730 81731 81776 82512 83577 83765 83987 83994 84015 55733 60127 81732 62190 81361 60734 57751 58311 58587 58594 59726 59843 59864 59878 59932 60123 60296 60354 60646 62432 63959 64991 65119 72035 72076 72080 72093 72236 73040 73510 73522 74063 74070 75058 75088 75097 76567 76850 76862 77600 78444 78464 79652 79678 79680 80044 80236 80980 82302 82335 82508 82518 82543 82847 82859 82866 82870 83593 64243 71552 72102 76868 78991 55425 57072 57600 57826 57928 60959 62347 63503 64295 65436 70410 70446 70496 70544 70711 72312 74782 74783 75601 75615 75779 76068 76330 77268 77490 77655 77878 79159 79163 81365 83590 56672 60729 60885 79008 76638 58523 61319 65140 65439 72264 79702 77619 80636 55189 55740 55823 56214 56422 56836 57353 57372 57882 59302 59360 60084 60532 60536 60613 60695 61340 61727 62038 62160 63318 64234 70260 70327 70330 70746 70760 71467 71802 72676 74341 74418 75302 75332 77497 77573 77848 79707 81392 83760 83787 83995 58660 59297 63922 70220 70311 70492 71276 80977 82295 56694 61009 61852 62162 64480 65131 70744 71498 72282 72291 72485 73282 73487 73508 74066 75060 75327 75346 76216 76276 76554 76604 76796 76853 77151 77857 78534 78770 78781 73810 71016 71805 60174 70542 64824 80701 73405 55052 64951 55963 58697 59949 60128 60582 62972 63999 64431 64709 64765 64774 64781 71402 75337 77298 79965 58934 76243 70671 71217 71214 71416 73369 74058 80015 60897 55722 56408 57088 57733 57868 57879 57889 57955 61070 61379 61818 61970 62028 62449 62773 62791 63332 63517 63537 64159 64249 64706 64798 64800 65334 65423 71764 72663 72901 74290 75369 77575 77601 77626 77658 77834 77882 80967 80970 80997 81691 81692 81698 81710 81711 81721 55167 55195 55393 57125 57391 57428 57637 59010 59733 59911 60586 61714 65347 65387 65531 71218 71501 71801 74315 78505 79208 80029 80047 80995 81693 61836 55818 56416 56522 61053 61534 61544 64439 65369 65529 56450 56173 56885 56912 63969 71256 72032 56194 55696 56827 56923 65124 65355 72974 73041 74084 74472 76849 78480 55659 56371 64651 64666 70255 73365 82307 74834 70319 77478 55070 72886 73313 76284 82286 57867 57896 59287 59315 59890 59503 55411 56744 62339 64715 64891 65459 81781 82525 82535 75612 76831 81350 82526 82544 55363 57635 60654 62752 62824 63149 63934 64987 76662 55030 57409 57754 77466 78757 55032 55525 56447 56632 56763 59927 60294 61024 64165 64256 64479 64722 64820 71464 72068 74468 74776 75064 77850 79139 80351 80398 80817 63493 63700 75300 57860 60385 63984 65451 70235 71486 71776 71800 76677 79673 80380 81368 82496 75569 77160 78793 57912 57611 71245
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Sylmar, CA, by letter and press release on October 7, 2005. Firm initiated recall is ongoing.
REASON
Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent loss of defibrillation support.
VOLUME OF PRODUCT IN COMMERCE
Approximately 36,000 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
The Applied GelPort Hand Access Device, Model C8004, consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template, UPC Codes: C8004 +H699C80040K. Recall # Z-0151-06
CODE
Lot Number/Expiration Date:1001381/2008-08
RECALLING FIRM/MANUFACTURER
Applied Medical Resources Corp, Rancho Santa Margarita, CA, by letter on October 14, 2005. Firm initiated recall is ongoing.
REASON
The product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system, Recall # Z-0153-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Renal Division, McGaw Park, IL, by letters dated August 29, 2005.
Manufacturer: Mesys Gmbh, Hannover, Germany. Firm initiated recall is ongoing.
REASON
A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms without an obvious cause.
VOLUME OF PRODUCT IN COMMERCE
255 units
DISTRIBUTION
Nationwide, China and Belgium

_______________________________
PRODUCT
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX, Recall # Z-0154-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Medrad, Inc., Indianola, PA, by letter dated October 12, 2005. Firm initiated recall is ongoing.
REASON
The heat maintainer, an accessory, may overheat and deform the disposable syringe.
VOLUME OF PRODUCT IN COMMERCE
4,362 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Boehringer Suction Regulator, Model number: 3704,
Recall # Z-0155-06;
b) Boehringer Suction Regulator, Model number: 3704D3,
Recall # Z-0156-06;
c) Boehringer Suction Regulator, Model number: 3714,
Recall # Z-0157-06
CODE
a) Lot numbers 05F and 05G;
b) and c) Lot number: 05F
RECALLING FIRM/MANUFACTURER
Boehringer Laboratories, Inc., Norristown, PA, by telephone on July 25, 2005. Firm initiated recall is complete.
REASON
Condition exists that prevents complete shutoff of the valve.
VOLUME OF PRODUCT IN COMMERCE
1,829 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
ICCG AC-Powered Adjustable Medical Bed, Model Numbers:1102550, 026757, 720-3M-80PR, IH720-3MQS, IH720-3M, 720-3M-76PR, IH720-2M, IHSC900, 026746, SC900-80P, SC90080L, SC900-76L, 720FULL, IHMC2MFP76, IHMC2MF80, IHMC2MF76, IHMC2MFP76, IHMC3MFP80, IHMC3ZP4I6, IHMC2M3ZP41, IHMC23ZP236, IHMC3SP23, 1H3MRFR76, IH3MRFR80, IH3MR2076, IH3MR2080, IH3MR8FR76, IH3MF8FRU6, IH3MR8FR80, IH3MF8FRU, Recall # Z-0158-06
CODE
The serial numbers: 00Axxxxx thru 00Kxxxxx; 99Axxxxx thru 99Lxxxxx & 98Cxxxxx thru 98Lxxxxx.
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Elyria, OH, by telephone and letter on July 23, 2004. Firm initiated recall is ongoing.
REASON
Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure.
VOLUME OF PRODUCT IN COMMERCE
14,321 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550, Recall # Z-0159-06
CODE
Serial numbers 12040401AB through 12040420AB, serial number 12050501AB and above, and those pumps that had syringe clamp assembly AAS5001503RP replaced on refurbished or serviced AS50 pumps since 5/14/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated May 5, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing.
REASON
A "Check Flange" alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
VOLUME OF PRODUCT IN COMMERCE
10,414 pumps
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Ohmeda Giraffe Spot PT Lite Phototherapy System, Recall # Z-0160-06
CODE
Serial numbers: HEBE50008 - HEBE50019; HEBF50001 - HEBF50311; HEBG50001 - HEBG50751; HEBH50001 - HEBH50950; HEBJ50000 - HEBJ50432; HEBG54001 - HEBG54035; HEBH54001 - HEBH54999; HEBH55000 - HEBH55041; HEBJ55033 - HEBJ55036
RECALLING FIRM/MANUFACTURER
Ohmeda Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by letter on August 5, 2005. Firm initiated recall is ongoing.
REASON
Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
VOLUME OF PRODUCT IN COMMERCE
2,701 devices
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Cardinal Health Custom Sterile Latex Free Convenience
Kits; sterile single use disposable devices packaged
in plastic pouches; identified by the following catalog
numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack
b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack
c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack
d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack
e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk
f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack
g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack
h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack
i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk
j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack
k) Cat. SOP30THDTD - Sterile Total Hip Pack
l) Cat. SOP30THNOA - Sterile Total Hip Pk
m) Cat. SOP30THSJA - Sterile Total Hip Pack
n) Cat. SOP30TKSJA - Sterile Total Knee Pack
o) Cat. SOP30THVCH - Sterile Total Hip Pack
p) Cat. SOP30TKVCE - Sterile Total Knee Pack,
Recall # Z-0163-06;
b) Cardinal Health Presource PBDS Latex Free Convenience
Kits; sterile single use disposable devices packaged
in plastic pouches; identified by the following catalog
numbers: a) Cat. PO23AAMCC - Arthroscopy Kit
b) Cat. PO23TKMCC - Total Knee Kit
c) Cat. SOP11OPFGB - Ortho Pack
d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk,
Recall # 0164-06
CODE
a) Cat. POOCOTFGB, order numbers 9904815, 9911445,
9911446, 9923559, 9926928, 9929035 and 9932551;
Cat.SOP22ARCLC, order number 144191;
Cat. SOP30ARCOB, order number 704460;
Cat. SOP30ARCOC, order numbers 713043 and 717623;
Cat. SOP30ARKGC, order number 716550;
Cat. SOP30ARMCB, order numbers 708643 and 717298;
Cat. SOP30ARNOA, order number 728554;
Cat. SOP30KANRA, order number 708579;
Cat. SOP30LENHC, order numbers 702865 and 714615;
Cat. SOP30SADTE, order number 717371;
Cat. SOP30THDTD, order number 715392;
Cat. SOP30THNOA, order number 728333;
Cat. SOP30THSJA, order number 710742;
Cat. SOP30TKSJA, order number 709389;
Cat. SOP30THVCH, order numbers 709885 and 719564;
Cat. SOP30TKVCE, order numbers 703408 and 716341;
b) Cat. PO23AAMCC, order numbers 641370 and 655171;
Cat. PO23TKMCC, order numbers 637245 and 639306;
Cat. SOP11OPFGB, order numbers 640349, 641634,
644009, 651563 and 653696;
Cat. SCV48CVJHD, order numbers 722851 and 728463
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by letter dated October 3,2005. Firm initiated recall is ongoing.
REASON
The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
VOLUME OF PRODUCT IN COMMERCE
1,502 packs
DISTRIBUTION
SC, NY, NB, FL, and Canada

_______________________________
PRODUCT
a) S2 System, Locking Screw Partially Threaded,
Catalog No. 1791-5065S to 1791-5120S;
Recall # Z-0166-06;
b) S2 System, Locking Screw Fully Threaded,
Catalog No. 1796-5065S to 1796-5120S,
Recall # Z-0167-06;
c) S2 System, Condyle Screw, Catalog No. 1795-5090S
to 1795-5120S, Recall # Z-0168-06;
d) T2 System, Condyle Screw, Catalog No. 1895-5085S
to 1895-5120S, Recall # Z-0169-06;
e) Gamma System, Cross Screw, Self-Tapping
(Cleared under Grosse and Kempf Locking Nail System),
Catalog No 3370-5-035 to 3370-5-090,
Recall # Z-0170-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letter, on October 4, 2005. Firm initiated recall is ongoing.
REASON
Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
41,555
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
In2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). For the rapid quantification of hemoglobin A1c in whole blood, Recall # Z-0171-06
CODE
Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040
RECALLING FIRM/MANUFACTURER
Recalling Firm: Provalis Diagnostics, Orlando, FL, by telephone and FAX or email on May 20, 2005.
Manufacturer: Provalis Diagnostics Limited, Deeside, UK. Firm initiated recall is complete.
REASON
Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.
VOLUME OF PRODUCT IN COMMERCE
838 Kits of 10 test devices
DISTRIBUTION
FL, KY, IL, LA, MI, AZ, and GA

_______________________________
PRODUCT
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIM method, Recall # Z-0172-06
CODE
Catalog number OQWM
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE, by letter on July 29, 2005.
Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing.
REASON
Reports of false negative results on Sysmex Coagulation System.
VOLUME OF PRODUCT IN COMMERCE
2,987 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
VITROS VANC (vancoymycin) Reagent, REF #680 1709, Recall # Z-0173-06
CODE
01-5919, Exp. 5/31/2005 (EXPIRED): 01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters and e-mail dated October 12, 2005. Firm initiated recall is ongoing.
REASON
Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
VOLUME OF PRODUCT IN COMMERCE
784 boxes x 6 packs x 50 tests
DISTRIBUTION
Nationwide and Internationally

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Made in the U.S.A. Recall # Z-0139-06
CODE
All Spanish language Patient At-Home Guides, with item numbers other than item #157-1260-806ES Rev. A 7/04 printed on teh back cover of the manual
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, by letter on September 12, 2005.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON
The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.
VOLUME OF PRODUCT IN COMMERCE
524 manuals
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set, Recall #Z-0141-06
CODE
Lot 050-779
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by FedEx on September 13, 2005.
Manufacturer: Integra Neurosciences Ltd, Andover, UK. Firm initiated recall is ongoing.
REASON
Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
VOLUME OF PRODUCT IN COMMERCE
24 (four 1 packs)(four 5 packs)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
BD Bard-Parker Special Surgeon's Peridontia Blade, Sterile, Single Use, Reorder # 371712, Recall # Z-0152-06
CODE
Lot # 4174460
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Company, Franklin Lakes, NJ, by letter on June 30, 2005.
Manufacturer: Becton Dickinson Cariba, Las Piedras, PR. Firm initiated recall is complete.
REASON
Unit packages labeled with the incorrect blade edge. The incorrectly labeled unit packages indicate a 12 (single edged blade) is present, the actual blade present is a 12B (double edged blade).
VOLUME OF PRODUCT IN COMMERCE
11,900 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm, Catalog Number: 232220, Recall # Z-0161-06
CODE
Lot Number: JBV04259
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Mitek, a Johnson & Johnson Co., Raynham, MA, by letter on August 9, 2005.
Manufacturer: J-PAC, LLC, Somersworth, NH. Firm initiated recall is complete.
REASON
Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer.
VOLUME OF PRODUCT IN COMMERCE
5 boxes/10 units (50 pieces)
DISTRIBUTION
CA, NC, and VA

_______________________________
PRODUCT
"Fine Tuning Your Pump" booklet provided with Model MMT-515 and MMT-715 Insulin Infusion Pumps, Recall # Z-0162-06
CODE
All models shipped between October 1, 2004 and April 5, 2005.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by letter on April 27, 2005. Firm initiated recall is ongoing.
REASON
The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
VOLUME OF PRODUCT IN COMMERCE
Approximately 14,560
DISTRIBUTION
Nationwide, Bahamas, Bermuda, Canada, Mexico, and PR

_______________________________
PRODUCT
Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350, Recall # Z-0165-06
CODE
04/05-PH134
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone, letter, and sales representative visit on August 23, 2005.
Manufacturer: Biocomposites, Staffordshire, England. Firm initiated recall is complete.
REASON
The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.
VOLUME OF PRODUCT IN COMMERCE
495 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR NOVEMBER 23, 2005

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