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U.S. Department of Health and Human Services

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Enforcement Report for April 5, 2006

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.

April 5, 2006
06-14

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

______________________________
PRODUCT
Golden Lion brand Dried Ziziphus Jujuba Mill, Net Wt. 12 oz, UPC barcode # 7 34765 04008 6, Recall # F-105-6
CODE
No Coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import, Inc., Brooklyn, NY, by press release on January 24, 2006 and January 25, 2006.
Manufacturer: Taishin City Daxin Food Co., Ltd, Shuibu Town, China, firm initiated recall is complete.
REASON
The product contained undeclared sulfites (427 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
65 cases (50 -- 12 oz. packages per case)
DISTRIBUTION
NY

______________________________
PRODUCT
SMAK® Mushrooms marinated, Net wt. 23.45 oz. (670g) jars, barcode # 8 10263 00001 9, and 30.5 oz. (870g), barcode # 8 10263 00034 7, Recall # F-106-6
CODE
Best Before 09.03.2005/RL/458/DDH/1203
Best Before07.05.2005/T/4539/DDA/8503
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal Seafood Baza, Inc., Far Rockaway, NY, by press release and telephone on February 2, 2005.
Manufacturer: SMAK, Poland, firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling and analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY and PA

______________________________
PRODUCT
Greenfood Gold Continent brand Sliced Mushrooms, Net wt. 8.8 oz. (250g), Product of China. The product is packed in a sealed plastic package labeled almost entirely in Chinese. Serving size 84 (g) --- servings per container 3. UPC barcode #6 930720 120624, Recall # F-107-6
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lion Pavilion Ltd., Brooklyn, NY, by press release and letters dated September 16, 2005.
Manufacturer: Chengdu Shizilou Food Co., Ltd., Chengdu, China, firm initiated recall is complete.
REASON
The product contained undeclared sulfites (322 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
104 cases (20 -- 8.8 oz. packages per case)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Aunt Jemima Frozen Cinnamon French Toast, 12.5 oz. cartons
with UPC code # 19600 05890. Cartons are packed 12 in a
case into cases with case code 001960005850;
and 18 cartons to a case into cases with
case code 001960005890, Recall # F-108-6;
b) Aunt Jemima Home Style Low Fat Waffles, 20 oz. cartons
with UPC code 19600 05130. Cartons area packed 8 to a case into
cases with case code 001960005340, Recall # F-109-6
CODE
a) Use by Date on or after June 12, 2006;
b) Use by Date on or after November 17, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by press release on January 20, 2006, and by letters on January 21, 2006.
Manufacturer: Pinnacle Sales Co., Knoxville, TN, firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
a) 66,276 cases 12/12/5 oz; 27,691 cases 18/12/5 oz;
b) 19,584 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Diabetisource AC Advanced-Control Tube Feeding For People With Diabetes. NET 50.7 FL OZ (1500 mL). Not For Parenteral Use. Medical food for use under medical supervision, Recall # F-112-6
CODE
Lot Code: 2135L
RECALLING FIRM/MANUFACTURER
Novartis Medical Nutrition, Novartis Nutrition Corp., Saint Louis Park, MN, by letter, dated November 11, 2005, and by telephone on November 11, 2005 or November 14, 2005, firm initiated recall is ongoing.
REASON
A portion of RESOURCE Diabetic TF, Lot 2135L, has been incorrectly packaged into containers identified and labeled as Diabetisource AC. RESOURCE Diabetic TF contains caseinate, a component of milk, while Diabetisource AC does not. Further, Diabetisource provides 1800 calories and 150 g carbohydrate while RESOURCE Diabetic TF provides 1590 calories and 127 g carbohydrate.
VOLUME OF PRODUCT IN COMMERCE
1,341 cases of 6 bottles per case
DISTRIBUTION
AL, CA, FL, GA, MA, MS, NC, OR, SC, TX, and WA

______________________________
PRODUCT
Egg, Cheese and Vegetable Taco labeled as follows: 68017 Egg Cheese & Vegetable Taco, Simplot Flame-Roasted Peppers & Onions w/Seasoning, Exquisita Tortilla: 50/4.5 ox Tacos, weight: 14.06 lbs -- 6.38 kgs, Keep Frozen, Recall # F-113-6
CODE
Pack Day: October 19, 2005, Lot Number: 81629205 (last two digits change with production sequence number)
RECALLING FIRM/MANUFACTURER
H & H Meat Products Co., Mercedes, TX, by telephone and letter on October 28, 2005, firm initiated recall is complete.
REASON
Firm's analysis found the product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approximately 228 cases of 50/4.5 oz. tacos
DISTRIBUTION
TX and TN

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PRODUCT
Union Rex brand Sun Dried Tomatoes, 5 lb. packages, Item # DT040, Recall # F-114-6
CODE
Lot # starting Apr-05 through Nov-05
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Cheese Works, Ltd., Ringwood, NJ, by letters on January 4, 2006 and by press release on January 9, 2006, firm initiated recall is ongoing.
REASON
Sun Dried Tomatoes contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
142 cases of 5x5 lb. bags
DISTRIBUTION
Nationwide

 

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

______________________________
PRODUCT
The product is GIARDINERA also spelled GIARDINIERA. A mixture of various vegetables and ingredients: celery, cauliflower, celery, peppers, pepperoncini, water, vinegar, salt, benzoate of soda, and sodium bisulfite (or potassium meta bisulfite) added as a preservative. The product is packaged in 1 gallon (128 oz.) plastic containers (4 - 1 gallon plastic containers per case), and sold unlabeled to Oxford Foods, and labeled as "FANCY GIARDINERA" under the "BLOCK & BARREL" label to Sysco Corp. The product is also packaged in 5 gallon pails (18.925L) and labeled as "Tutino's GIARDINIERA" which was sold to Antonucci Wholesale Produce Inc. Recall # F-117-6
CODE
No label (Oxford Foods): Lots (date code) 6012A & 6013A; "Block & Barrel" label: Lot (date code) 01216A; "Tutino's" label: Lot 0136A
RECALLING FIRM/MANUFACTURER
East Coast Olive Oil Corp, Utica, NY, by telephone, fax and letter on February 16, February 17, 2006 and February 28, 2006, firm initiated recall is ongoing.
REASON
The product may contain glass particles. The firm was notified by one of its customers of the presence of glass particles inside the plastic containers.
VOLUME OF PRODUCT IN COMMERCE
Oxford product: 192 cases, Sysco product: 24 cases, Antonucci product: 12-5 gallon pails
DISTRIBUTION
NY and MA

______________________________
PRODUCT
The Master's Miracle Skin Moisturizer, 8 FL OZ (232 ML). Natural Oils & Emollients. Store at room temperature. Made in USA. Product is sold individually, 4 pack and 8 pack. Catalog numbers are as follows: Individual bottle #7690; 4-pak #11551; 8-pack #8974; Wholesale Membership Package 1 # 7696; Family Care Package #2 with Flax Hull Lignans # 11897; Family Care Package #2 with Greens #11896; Business Builder Package #3 with Flax Hull Lignans #11899; and Business Builder Package #3 with Greens #11898, Recall # F-118-6
CODE
Date Code: 04338SM. Batch # 109.
RECALLING FIRM/MANUFACTURER
The Master's Miracle, Maple Grove, MN, by verbal communication beginning on June 24, 2005, firm initiated recall is ongoing.
REASON
The product contains Stenotrophomonas maltophila and Staphylococcus warneri.
VOLUME OF PRODUCT IN COMMERCE
1,273 -- 8 oz. bottles
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Hostess Banana Walnut Mini Muffins packages as 5 muffin snack packs and multi packs containing 4 snackpacks of 5 muffins each, Recall # F-119-6
CODE
Lots 335062A, 335062B and 335062C. Products contain a pull date of JAN15
RECALLING FIRM/MANUFACTURER
Interstate Brands Corp., Indianapolis, IN, by visit between January 7, 2006 and January 10, 2006, firm initiated recall is complete.
REASON
Product may contain small pieces of glass.
VOLUME OF PRODUCT IN COMMERCE
1,836,400 muffins
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Hunt's Squeezn' Go Vanilla Pudding Tubes 9,
8-pack 64-Gram Tubes, 0-58807-41742-2, Recall # F-120-6;
b) Hunt's Squeezn' Go Orange Pudding Tubes 9,
8-pack 64-Gram Tubes, 0-58807-41727-9, Recall # F-121-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: M-C McLane International, The Woodlands, TX, by telephone beginning on January 23, 2006, firm initiated recall is ongoing.
REASON
Product contains undeclared FD & C Yellow #5;
Product contains undeclared FD & C Yellow #6
VOLUME OF PRODUCT IN COMMERCE
7,942 cases
DISTRIBUTION
OH, VA, MO, KY, and MS

______________________________
PRODUCT
a) Wrigley's Juicy Fruit Chewing Gum Goma de Mascar, Recall # F-122-6;
b) Wrigley's Doublemint Chewing Gum Goma de Mascar, Recall # F-123-6
CODE
a) Code: 26411 - All lots;
b) Code: 26410 - All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferrero, Inc., Caguas, PR, by visit beginning on March 1, 2006.
Manufacturer: Wrigley France S.N.C., Biesheim, France, firm initiated recall is ongoing.
REASON
Product contains Yellow # 5 declared in the label as "Tartrazine".
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
PR

______________________________
PRODUCT
a) Wrigley's Juicy Fruit Chewing Gum Goma de Mascar, Recall # F-124-6;
b) Wrigley's Doublemint Chewing Gum Goma de Mascar, Recall # F-125-6
CODE
a) Code: 20239 - All lots;
b) Code: 20238 - All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferrero, Inc., Caguas, PR, by visit beginning on March 1, 2006.
Manufacturer: Wrigley Phillippines, Inc., Antipolo, Phillippines, firm initiated recall is ongoing.
REASON
Product contains Yellow # 5 declared in the label as "Tartrazine".
VOLUME OF PRODUCT IN COMMERCE
26220 boxes of 60 packages of 2 pieces
DISTRIBUTION
PR

 

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

______________________________
PRODUCT
Uncle Chen brand Black Bean Garlic Sauce in 8 oz. -- 24/case and 16 oz. -- 12/case plastic jars, Recall # F-110-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Union Food International Company, Union City, CA, by telephone and visits beginning on January 7, 2005 and by letters on January 10, 2005, firm initiated recall is complete.
REASON
Product is fermenting with unknown microbiological growth, and had displayed swelling containers.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA

______________________________
PRODUCT
a) Minute Main, Fruit Punch in 20 oz. plastic bottles
packed 24 per plastic shell, Recall # F-115-6;
b) Minute Main, Strawberry Passion in 20 oz. plastic bottles
packed 24 per plastic shell, Recall # F-116-6
CODE
a) MAR2006LWC;
b) APR1006LWC
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Company (Corporate Offices), Atlanta, GA, by visit and letter on/about November 17, 2005.
Manufacturer: Coca Cola Bottling Company of Southwest, San Antonio, TX, firm initiated recall is complete.
REASON
Products are spoiled due to yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
769 cases
DISTRIBUTION
AK, LA, TN, and TX

 

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Minitran (nitroglycerin) Transdermal Delivery System. 0.1 mg/hr. This system is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. NDC 0089-0301-02, Recall # D-215-6
CODE
Lot no. 050359, expires May 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company, St Paul, MN, by letters dated December 16, 2005.
Manufacturer: 3 M Company, Northridge, CA, firm initiated recall is ongoing.
REASON
Subpotent: partial patches will deliver less than the labeled amount of 0.1 mg/hr.
VOLUME OF PRODUCT IN COMMERCE
311,040 patches (30 patches per box)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Oncaspar (Pegaspargase), Lot (1 unit dose per unit package) BLA STN 103411, 750 I.U. per mL, Sterile, NDC 57665-002-02, Recall # D-216-6
CODE
Lot AF02424, Exp. 8/24/2006
RECALLING FIRM/MANUFACTURER
Enzon Pharmaceuticals, Inc., South Plainfield, NJ, by letters on March 14, 2006, firm initiated recall is ongoing.
REASON
Superpotent: At the 18 month stability station, the enzymatic activity is above specification coming in at 907 IU/mL. (Spec. 600-900 IU/mL).
VOLUME OF PRODUCT IN COMMERCE
1,746 vials
DISTRIBUTION
Nationwide, Canada, New Zealand, Singapore, and Australia

 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Hydrocortisone Valerate Cream USP, 0.2%, 15 g tube, Rx only, NDC 51672-1290-1, Recall # D-214-6
CODE
Lot 5E040 (exp. Aug 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by telephone and letters, dated February 24, 2006.
Manufacturer: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, firm initiated recall is ongoing.
REASON
Sub-Potency: Out of specification (below potency) assay values obtained during stability testing for hydrocortisone valerate cream at 9-month test station. Two tubes were at approx.85% (specification is 90.0% - 110.0%).
VOLUME OF PRODUCT IN COMMERCE
21,984 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

______________________________
PRODUCT
Human Corneas for Transplantation Tissues, Recall # B-0561-6
CODE
Tissues: 05-0191-100 and 05-0191-200
RECALLING FIRM/MANUFACTURER
Mid South Eye Bank for Sight Restoration, Inc., Memphis, TN, by telephone on September 23, 2005, firm initiated recall is complete.
REASON
Human tissues for transplantation, recovered from a donor who was subsequently found to have tested positive for the hepatitis C virus by both NAT and antibody testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
NY

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-0382-6
CODE
Unit numbers: N-37471-097, N-37494-097, G-91707-097, G-91940-097, G-92659-097,
G-92907-097, G-93645-097, G-93924-097, G-95831-097, G-96149-097, G-97647-097,
G-98705-097, G-99010-097, G-05826-097, G-06673-097, G-07071-097, G-08072-097,
G-08749-097, G-09126-097, G-09719-097, G-10033-097, G-10970-097, G-11232-097,
G-12389-097, G-12716-097, G-13674-097, F-00078-097, F-00367-097, F-01024-097,
F-01399-097, F-02473-097
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., San Diego, CA, by fax on November 14, 2002, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
CA and Spain

______________________________
PRODUCT
Source Plasma, Recall # B-0597-6
CODE
Unit numbers: SP-20158, SP-20620, SP-20633, SP-20714, F-00335-044, F-00455-044, F-00483-044, F-00670-044, F-00706-044, F-00828-044, F-00872-044, F-01171-044, F-01273-044, F-01315-044
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by letter dated October 24, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
CA and Austria

______________________________
PRODUCT
Source Plasma, Recall # B-0668-6
CODE
Unit numbers: G-05988-072, F-00081-072, F-01523-072, F-02979-072, F-19651-072, F-21287-072, F-22556-072, F-23698-072
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Long Beach, CA, by fax on February 14, 2003, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0754-06
CODE
Unit number: 06LR01358
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on November 21, 2002 and by letter dated November 24, 2002, firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-1), but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0782-6
CODE
Units (2 units) 004KC33387 -- parts 1 and 2
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by telephone on December 10, 2005, and by letter dated December 12, 2005, firm initiated recall is complete.
REASON
Platelets, possibly contaminated with bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VT and MA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0787-6
CODE
Unit number: 113431788
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on September 8, 2004, firm initiated recall is complete.
REASON
Blood product, which tested initially non-reactive for West Nile Virus (WNV) when tested in a pool of 16 donations, but was not tested individually for WNV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Human Corneas for Transplantation, Recall # B-0790-6
CODE
Tissues 0078-06-01, 0078-06-02
RECALLING FIRM/MANUFACTURER
North Carolina Eye Bank, Dorham, NC, by telephone on January 23, 2006, firm initiated recall is complete.
REASON
Human tissues for transplantation, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
NC and TX

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0792-6
CODE
Unit number: 55P46462
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR,
by telephone on November 9, 2004, firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR

______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0794-6
CODE
Unit number: 5650054
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 23, 2005, firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of red cells that was possibly contaminated with coagulase-negative Staphylococcus and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0795-6
CODE
Unit number: 22GL27322
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on October 4, 2005, and by letter dated October 7, 2005, firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were possibly contaminated with coagulase-negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Human Saphenous Vein, Recall # B-0796-6
CODE
Tissue number: 8306257
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter dated January 27, 2006, firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
MA

______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0797-6
CODE
Unit number: 16GW44163
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on August 10, 2005 and by letter dated August 17, 2005, firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of red cells that was implicated in a transfusion reaction and was possibly contaminated with Aeromonas hydrophilia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Human Cornea Tissue for Transplantation, Recall # B-0799-6
CODE
Tissue number: 05-1136 OD
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by letter dated December 16, 2005, firm initiated recall is complete.
REASON
Human Cornea, placed in an expired viewing chamber, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
Japan

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0802-6
CODE
Unit numbers: 40P06964-P1, 40P06964-P2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on September 23, 2005 and follow-up letter on October 3, 2005, firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit after the acceptable time period for use was exceeded, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0807-6
CODE
Unit number: 03F16197
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on March 29, 2004 and by letter April 2, 2004, firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0811-6;
b) Platelets, Recall # B-0812-6;
c) Fresh Frozen Plasma, Recall # B-0813-6;
d) Recovered Plasma, Recall # B-0814-6
CODE
a) Unit numbers: 12V06564, 12P80910, 12C81080,
12X37662, 12X35755;
b) Unit number: 12X37662;
c) Unit number: 12X37662;
d) Unit numbers: 12C81080, 12P80910, 12V06564, 12X35755
RECALLING FIRM/MANUFACTURER
American National Red Cross, Asheville, NC, by letter dated August 13, 1999, or by facsimile dated October 5, 1999, firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previously positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC and CA

______________________________
PRODUCT
Baxter ALYX Red Kit, For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation, For Use with the ALYX Instrument; sterile single use unit consisting of a separation chamber, an umbilicus, a cassette, 1 container 0.9% sodium chloride, 1 container ACD-A anticoagulant, 1 container Adsol Red Cell Preservative Solution, 3 blood component containers, 2 red cell storage containers, 1 18 gauge needle and 1 Sepacell leukoreduction filter, Recall # B-0816-6
CODE
All lot numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G and H05H, except those lots suffixed with "A" (H05I02028A, H05I13041A and H05I19071A)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letter dated October 28, 2005 and by e-mails on October 26, 2005 and November 4, 2005.
Manufacturer: Baxter Healthcare Corporation, Mountain Home, AR, firm initiated recall is complete.
REASON
Apheresis kits, manufactured with potential for leaks from the cassette of the disposable kit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
122,676 kits representing 67 lots
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0821-6
CODE
Unit number: 06LE31558
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on February 11, 2005 and by letter on February 16, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0822-6
CODE
Unit numbers: 12645-8676 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 22, 2005.
Manufacturer: Blood Systems, Inc., Albuquerque, NM, firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM

______________________________
PRODUCT
Red Blood Cells, Recall # B-0823-6
CODE
Unit number: 6029974
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated January 7, 2005, firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0825-6
CODE
Unit numbers: 2120513, 2116438
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on December 16, 2004, firm initiated recall is complete.
REASON
Blood products, associated with units of Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

______________________________
PRODUCT
Platelets, Recall # B-0826-6
CODE
Unit number: 2166218
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on January 21, 2005, firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

______________________________
PRODUCT
Red Blood Cells, Recall # B-0827-6
CODE
Unit number: 36FQ28150
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone and by letter dated July 14, 2000, firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0830-6
CODE
Unit number: 06GC13649
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on January 28, 2003, firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as being negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0831-6
CODE
Unit numbers: 004GR31489 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on November 19, 2005, firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
Platelets Pheresis, Irradiated, Recall # B-0834-6
CODE
Unit number: 06KR35274
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on August 5, 2003, and by letter on September 16, 2003, firm initiated recall is complete.
REASON
Blood product, with elevated platelet counts, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0839-6
CODE
Unit number: 1249550
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on March 8, 2005, firm initiated recall is complete.
REASON
Platelets, with a low yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B- 0840-6;
b) Recovered Plasma, Recall # B-0841-6
CODE
a) Unit number 4835787;
b) Unit number 4642919
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on December 17, 2002 and facsimile on December 20, 2002, firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0842-6
CODE
Unit number: 3178210
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on August 23, 2005, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Source Plasma, Recall # B-0843-6
CODE
Unit numbers: G20953014, G21541014, G21942014, G22813014, G23670014, G24004014, G25274014, G25494014, G26751014, G26999014, and G27681014
RECALLING FIRM/MANUFACTURER
Alpha Therapeutics Corporation, National City, CA, by facsimile on February 4, 2002, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Spain

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0844-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0845-6
CODE
a) Unit number: 40FY44368;
b) Unit number: 40FP22168
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on October 11, 2005 and by letter dated October 14, 2005, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0847-6
CODE
Unit number: LW12295
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 25, 2005, firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0850-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0851-6
CODE
a) Unit numbers: 18238-5378, 18238-7088, 18238-7097;
b) Unit numbers: 18238-6876, 18238-7088
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated November 22, 2005.
Manufacturer: Blood Systems, Inc., Cheyenne, WY, firm initiated recall is complete.
REASON
Blood products, collected in apheresis collection kits that may have exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WY

______________________________
PRODUCT
Platelets, Recall # B-0852-6
CODE
Unit number: L94697
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on January 6, 2006, firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets, Recall # B-0853-6
CODE
Unit number: N25356
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by telephone on July 7, 2005, firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
Red Blood Cells, Recall # B-0854-6
CODE
Unit number: S84804
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on February 10, 2006, firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0855-6;
CODE
Unit number: 04FJ43633
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile and by letter dated on December 9, 2005, firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was subsequently determined to have previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0857-6
CODE
Unit number: 4167724
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on May 2, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
Red Blood Cells, Recall # B-0786-6
CODE
Unit numbers: 18X74361, 18X74362, 18X74363
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by letter dated July 13, 2005, firm initiated recall is complete.
REASON
Blood products, for which the storage temperature of the donor thermometers exceeded the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0788-6;
b) Recovered Plasma, Recall # B-0789-6
CODE
a) and b) Unit numbers: 03GK31284, 03LR49415
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by letter dated July 17, 1998, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0793-6
CODE
Unit number: S47299
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on May 6, 2005, firm initiated recall is complete.
REASON
Blood product, untested for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0798-6
CODE
Unit numbers: 16KF48433
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on May 11, 2005 and by letter dated May 25, 2005, firm initiated recall is complete.
REASON
Blood products, for which platelet cross-match testing was incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0810-6
CODE
Unit number: 36N05072
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on March 7, 2003, firm initiated recall is complete.
REASON
Fresh Frozen Plasma, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Six Bag Aliquot System with piercing pin and injection site; Size 150 mL, Recall # B-0815-6
CODE
Product Code T2186; Lot 109851
RECALLING FIRM/MANUFACTURER
Charter Medical Limited, Winston Salem, NC, by facsimile dated November 21, 2005, firm initiated recall is complete.
REASON
Transfer packs, mislabeled with an incorrect bag volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,464 units
DISTRIBUTION
CA, FL, IL, and OH

______________________________
PRODUCT
Red Blood Cells, Recall # B-0828-6
CODE
Unit number: 06FS93865
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on July 8, 2005, firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0829-6
CODE
Unit numbers: 06FM23362, 06FM23387
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letter dated March 7, 2003, firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ and CA

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0832-6
CODE
Unit number: 33GN02171
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on December 6, 2005 and by letter dated December 8, 2005, 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
CT

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0837-6
CODE
Unit number: 211FM47855 -- split product
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letters dated May 3, 2005 and May 6, 2005, firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus sphaericus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis, Leukocyte Reduced, Recall # B-0838-6
CODE
Unit numbers: 211FM37798 -- split unit
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letters dated April 11, 2005 and May 3 2005, firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0846-6
CODE
Unit number: FH02840
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on October 11, 2005, 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
IL

______________________________
PRODUCT
Recovered Plasma, Recall # B-0856-6
CODE
Unit number: 04FJ43633
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile on December 12, 2005, firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was subsequently determined to have previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0858-6
CODE
Unit number: 1253053
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on April 2, 2005, firm initiated recall is complete.
REASON
Blood product, which was irradiated twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device, Recall # Z-0533-06
CODE
Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter beginning February 23, 2006.
Manufacturer: Cmt Medical Technologies Ltd, Haifa, Israel, firm initiated recall is ongoing.
REASON
When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set,
product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0",
mL Vol., with 2 Luer Activated Valves and a male Luer Lock adapter;
Recall # Z-0625-06;
b) Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191;
An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male
Luer Lock adapter; Recall # Z-0626-06;
c) Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile,
nonpyrogenic fluid pathway, 6.4", 0.4 mL Vol., with male Luer Slip T-Connector,
Recall # Z-0627-06;
d) Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194,
An Rx sterile, nonpyrogenic fluid pathway, 7.0", 0.3 mL Vol., with male Luer
Lock adapter, Recall # Z-0628-06;
e) Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter
Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid
pathway with 2 Interlink injection sites and a male Luer Lock adapter;
Recall # Z-0629-06;
f) Baxter Interlink System T-Connector Extension Set, product code 2N3343;
An Rx sterile, nonpyrogenic fluid pathway, 7.0", 1.0 mL Vol., with 1 Interlink
T-connector injection sites and male Luer Lock adapter with retractable collar
and 1 Interlink Y-injection site. Recall # Z-0630-06;
g) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345;
An Rx sterile, nonpyrogenic fluid pathway, 36", 0.38mL Vol, with male Luer
Lock adapter, Recall # Z-0631-06;
h) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348;
An Rx sterile, nonpyrogenic fluid pathway, 60", 0.5mL Vol, with male Luer
Lock adapter, Recall # Z-0632-06;
i) Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349;
An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male
Luer Lock adapter; Recall # Z-0633-06;
j) Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product
code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.5 mL Vol.,
with injection site and male Luer Lock adapter with Retractable Collar.
Recall # Z-0634-06;
k) Baxter Mini-Infuser Microbore Extension Set, product code 2C9203;
An Rx sterile, nonpyrogenic fluid pathway, 61", 0.9 mL Vol., with male
Luer Lock adapter, Recall # Z-0635-06;
l) Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic
fluid pathway, 72", 1.7 mL Vol., with Luer Lock adapters, Recall # Z-0636-06;
m) Baxter Interlink System Minivolume Extension Set, product code 1C8290;
An Rx sterile, nonpyrogenic fluid pathway, 11.0", 0.86 mL Vol.,
with 2 injection sites and male Luer Lock adapter, Recall # Z-0637-06;
n) Baxter Interlink System Minivolume Extension Set, product code 1C8378;
An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.6 mL Vol., with injection
site and male Luer Lock adapter, Recall # Z-0638-06;
o) Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile,
nonpyrogenic fluid pathway, 13.0", 0.4 mL Vol., with male Luer Lock adapter,
Recall # Z-0639-06;
p) Baxter Interlink System Minivolume Extension Set, product code 1C8412;
An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol., with injection site,
0.22 Micron Downstream Filter and male Luer Lock adapter, Recall # Z-0640-06;
q) Baxter Interlink System Minivolume Extension Set, product code 1C8462;
An Rx sterile, nonpyrogenic fluid pathway, 16.0", 4.2 mL Vol., with 2 injection sites,
0.22 Micron Downstream High Pressure Extended Life Filter and male Luer Lock
adapter, Recall # Z-0641-06;
r) Baxter Interlink System Minivolume Extension Set, product code 1C8483;
An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron
Downstream Filter, 2 injection sites and a male Luer Lock adapter,
Recall # Z-0642-06;
s) Baxter Interlink System Minivolume Extension Set, product code 1C8590;
An Rx sterile, nonpyrogenic fluid pathway, 22", 0.9 mL Vol, with injection site
and Stationary Swivel Lock T-Connector, Recall # Z-0643-06;
t) Baxter Interlink System Minivolume Extension Set, product code 1C8643;
An Rx sterile, nonpyrogenic fluid pathway, 7", 0.3 mL Vol, with Male Luer
Slip T-Connector, Recall # Z-0644-06;
u) Baxter Non-DEHP Minivolume Extension Set, product code 1C8690;
An Rx sterile, nonpyrogenic fluid pathway, 8", 0.22 mL Vol, with male
Luer Lock adapter, Recall # Z-0645-06;
v) Baxter Interlink System Extension Set with Standard Bore 4-Way
Stopcock Manifold Extension Set and Minivolume Extension Set,
product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway;
extension set: 19", 3.2 mL Vol., with injection site and male Luer
Lock adapter, manifold extension set: 46", 6.2 mL Vol, male luer
adapter, and minivolume extension set: 10", 0.7 mL Vol, injection
site and stationary swivel lock T-connector, Recall # Z-0646-06;
w) Baxter Interlink System 3-Lead Extension Set, product code 1C8442;
An Rx sterile, nonpyrogenic fluid pathway, 6", 1.6 mL Vol., with 2 Interlink
Injection Sites and a Male Luer Lock adapter;, Recall # Z-0647-06;
x) Baxter Interlink System Y-Type Minivolume Extension Set, product code
1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.8 mL Vol.,
with 2 injection sites and male Luer Lock adapter, Recall # Z-0648-06;
y) Baxter Y-Type Minivolume Extension Set, product code 1C8689;
An Rx sterile, nonpyrogenic fluid pathway, 6.0", 0.33 mL Vol.,
with male Luer Lock adapter, Recall # Z-0649-06;
z) Baxter Clearlink System Non-DEHP Minivolume Extension Set,
product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway,
7.0", 0.33 mL Vol., with Luer Activated Valve for IV Access and
male Luer Lock adapter, Recall # Z-0650-06;
aa) Baxter Clearlink System Non-DEHP Minivolume Extension Set,
product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway,
8.0", 0.6 mL Vol., with Luer Activated Valve for IV Access and male
Luer Lock adapter, Recall # Z-0651-06;
bb) Baxter Interlink System Minivolume Extension Set, product code
1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol.,
with injection site, 0.22 Micron Downstream Filter and male Luer Lock
adapter, Recall # Z-0652-06;
cc) Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way
Stopcock Manifold Extension Set and Minivolume Extension Set, product code
3C0078; An Rx sterile, nonpyrogenic fluid pathway; solution set: 74",
60 drops/mL, with injection site and male Luer Lock adapter, manifold
extension set: 29", 4 mL Vol, male luer adapter, and minivolume
extension set: 7", 0.4 mL Vol with retractable T-connector. Recall # Z-0653-06;
dd) Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way
Stopcock with Rotating Male Luer Lock Extension Set and Minivolume
Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic fluid
pathway; solution set: 58", 60 drops/mL, with 150 mL Burette Drip
Chamber Filter Valve, 2 injection sites and male Luer Lock adapter,
stopcock extension set: 43", 6.5 mL Vol with 2 injection sites and male
luer adapter, and minivolume extension set: 6", 0.4 mL Vol with male
luer slip T-connector, Recall # Z-0654-06;
ee) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way
Stopcock Extension Set and Minivolume Extension Set, product code
3C0128; An Rx sterile, nonpyrogenic fluid pathway; solution set: 105",
60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection
sites and male Luer Lock adapter, stopcock extension set: 34", 5.2 mL Vol
with injection site, minivolume tubing and male luer adapter, and minivolume
extension set: 3", 0.1 mL Vol with male luer lock adapter, Recall # Z-0655-06;
ff) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way
Stopcock with Rotating Male Luer Lock Extension Set and Extension Set,
product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution
set: 84", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve,
3 injection sites and male Luer Lock adapter, stopcock extension set: 21",
3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume
extension set: 6", 0.5 mL Vol with microvolume tubing and retractable
T-connector, Recall # Z-0656-06;
gg) Baxter Minivolume Extension Set, product code JC9944; An Rx sterile,
nonpyrogenic fluid pathway, 8", 0.4 mL Vol., with Luer Activated Valve,
Made in Canada, Recall # Z-0657-06
CODE
a) Lots UR254482, UR254763, UR255752;
b) Lots UR254839, UR255547;
c) Lot UR254987;
d) Lots UR255257, UR265512, UR255257;
e) Lots UR253385, UR255331, UR255505, UR261248, UR272211;
f) LotsUR254540, UR254847, UR260364;
g) Lots UR254961, UR255216;
h) Lots UR254581, UR255059, UR258806, UR258921;
i) Lots UR258939, UR258996, UR259150, UR259200;
j) Lot UR255125;
k) Lot UR244491;
l) Lots UR254607, UR255240;
m) Lots GR225490, GR227587, GR230052;
n) Lots GR225508, GR228395, GR230912, GR232058;
o) Lots GR226324, GR226803, GR228429, GR229781, GR230649, GR230854;
p) Lots GR225102, GR225359;
q) Lots GR227140, GR230664, GR231852, GR224659;
r) Lots GR227579, GR224238;
s) Lot GR228668;
t) Lots GR226811, GR228064;
u) Lots GD819433, GD819938, GR224675;
v) Lots GR226944, GR231183, GR224683;
w) Lots GR226340, GR228460;
x) Lots GR227173, GR228114, GR230060, GR224667;
y) Lot GD814186;
z) Lot GR225904;
aa) Lots GR228619, GR228874, GR228882, GR229179, GR231746;
bb) Lots GR229351, GR229500, GR229906, GR231050, GR231068,
GR232371;
cc) LotsGR229013, GR229799;
dd) Lots GR228981, GR229591, GR232033;
ee) Lots GR229609, GR230805;
ff) Lot GR230631;
gg) Lots ST05A165, ST05G091
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corporation, Round Lake, IL, by letters dated August 3, 2005 and December 15, 2005.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR, firm initiated recall is ongoing.
REASON
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
VOLUME OF PRODUCT IN COMMERCE
556,182 sets
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse Co?Oximeter, Recall # Z-0661-06
CODE
Serial Numbers: 4793 5108 5405 5792 6096 6261 6421 6576 4794 5109 5506 5797 6118 6263 6436 6578 4818 5115 5513 5800 6136 6265 6441 6596 4821 5123 5530 5811 6140 6266 6444 6604 4833 5139 5538 5816 6146 6268 6451 6608 4836 5169 5571 5828 6148 6274 6463 6628 4852 5176 5579 5838 6149 6277 6473 6638 4854 5182 5588 5839 6153 6283 6478 6645 4860 5186 5589 5841 6158 6287 6481 6664 4866 5187 5592 5845 6159 6288 6482 6666 4870 5191 5597 5848 6164 6302 6483 6668 4875 5194 5599 5852 6166 6304 6484 6671 4880 5196 5601 5856 6168 6309 6487 6673 4881 5197 5608 5868 6169 6310 6488 6678 4886 5199 5610 5870 6172 6311 6489 6680 4887 5201 5613 5872 6173 6313 6492 6683 4895 5219 5616 5877 6174 6318 6493 6686 4898 5220 5619 5884 6178 6320 6495 6690 4912 5221 5620 5934 6179 6321 6498 6696 4914 5224 5621 5939 6180 6324 6503 6697 4915 5226 5625 5949 6183 6325 6509 6743 4933 5233 5635 5960 6189 6326 6511 4934 5235 5649 5961 6196 6329 6514 4939 5236 5652 5966 6198 6333 6515 4968 5237 5656 5971 6199 6337 6517 4992 5238 5657 5979 6200 6338 6518 4994 5249 5662 5986 6201 6341 6520 5002 5252 5663 6017 6205 6343 6521 5013 5269 5664 6026 6207 6346 6525 5017 5274 5668 6029 6208 6353 6527 5022 5275 5679 6030 6209 6354 6529 5029 5278 5681 6034 6215 6363 6538 5031 5279 5682 6039 6217 6367 6539 5043 5281 5683 6040 6218 6368 6541 5049 5287 5690 6049 6220 6369 6542 5051 5288 5692 6051 6223 6374 6547 5052 5291 5693 6053 6224 6380 6550 5053 5317 5697 6056 6225 6381 6551 5054 5319 5699 6061 6230 6382 6552 5058 5321 5700 6065 6231 6385 6554 5061 5340 5704 6067 6232 6388 6555 5063 5361 5710 6070 6233 6392 6557 5069 5370 5724 6071 6235 6393 6559 5070 5371 5729 6074 6237 6394 6560 5075 5374 5744 6078 6239 6395 6566 5077 5376 5746 6079 6246 6397 6570 5091 5378 5750 6080 6247 6411 6571 5093 5380 5757 6084 6248 6413 6573 5096 5391 5758 6089 6256 6415 6574 5097 5398 5764 6094 6257 6419 6575
RECALLING FIRM/MANUFACTURER
Masimo Corporation, Irvine, CA, by letter on February 2, 2006, firm initiated recall is ongoing.
REASON
Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
VOLUME OF PRODUCT IN COMMERCE
321 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Stryker PainPump 1 Base Kit; Product number 500-100-000,
Recall # Z-0662-06;
b) Stryker PainPump 1 5-Day Infusion Kit; Product number 500-110-000,
Recall # Z-0663-06;
c) Stryker PainPump 1 2-Day Infusion Kit; Product number 500-120-000,
Recall # Z-0664-06;
d) Stryker PainPump 1 1-Day Infusion Kit; Product number 500-140-000,
Recall # Z-0665-06;
e) Stryker PainPump 1 2-Site Y -Connector; Product number 500-200-000,
Recall # Z-0666-06;
f) Stryker PainPump 1 2-Site Y -Connector; Product number 500-250-000,
Recall # Z-0667-06;
g) Stryker PainPump 1.5 Base Infusion Kit; Product number 501-100-000,
Recall # Z-0668-06;
h) Stryker PainPump 1.5 5-Day Infusion Kit; Product number 501-120-000,
Recall # Z-0669-06;
i) Stryker PainPump 1.5 2-Day Infusion Kit; Product number 501-140-000,
Recall # Z-0670-06
CODE
a) Lot 2005060702;
b) Lot 2005060701;
c) Lots 2005052002, 2005060703, 2005061401, 2005062001 and
2005063001;
d) Lot 2005051101 and 2005062301;
e) Lot 2005052501;
f) Lot 2005053102;
g) Lot 2005053004;
h) Lots 2005053003 and 2005060301;
i) Lots 2005053001, 2005060203, 2005062702 and
2005051002
RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. Of Stryker Corporation, Portage, MI, by letter dated February 7, 2006, firm initiated recall is ongoing.
REASON
The catheter tubing included in the kit may break during removal.
VOLUME OF PRODUCT IN COMMERCE
2,935 boxes
DISTRIBUTION
Nationwide, Australia and Canada

______________________________
PRODUCT
Cook Harrison fetal bladder stent set, sterile; RF J-HFBS-503540, Recall # Z-0674-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc, Spencer, IN, by letter dated March 1, 2006, firm initiated recall is ongoing.
REASON
Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
VOLUME OF PRODUCT IN COMMERCE
1,300 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
AMS Her Option Cryoablation Therapy Disposable Probe her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile, the Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe, Recall # Z-0675-06
CODE
Lots 431803 and 436666
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka, MN, by letter dated January 25, 2006, firm initiated recall is ongoing.
REASON
Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
152 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
General Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control, Catalog number: S1-32, Recall # Z-0676-06
CODE
Lot: A31, Exp. 2/2006 (Kit lot #F1458);
Lot A41, Exp.1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alfa Wassermann, Inc., West Caldwell, NJ, by letters on January 14, 2006- January 17, 2006-January 19, January 27, 30, 31 and February 1, 2006, firm initiated recall is ongoing.
REASON
Inaccurate test results. The magnesium values for the A31/A41 General Serum calibrator gave control results that were biased approx. 20% high.
VOLUME OF PRODUCT IN COMMERCE
22,897 kits
DISTRIBUTION
Nationwide and the Netherlands

______________________________
PRODUCT
Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only, Recall # Z-0677-06
CODE
Lot number 1146548
RECALLING FIRM/MANUFACTURER
Recalling Firm: St. Jude Medical/Daig Division, Minnetonka, MN, by e-mail and letters on August 22, 2005.
Manufacturer: St. Jude Medical, Puerto Rico B.V., Caguas, PR, firm initiated recall is ongoing.
REASON
Mispackaging -- Some Angio-Seal 6F STS Vascular Closure Devices have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
VOLUME OF PRODUCT IN COMMERCE
4,160 devices
DISTRIBUTION
Belgium, China, Guadalajara, New Zealand and Thailand

______________________________
PRODUCT
Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React®, Pulmonic Valve Conduit, NR4000-PA-C, Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React®' treatment*, INSTRUCTIONS FOR USE, Recall # Z-0678-6
CODE
Model NR4000PA-C (size 6 mm), serial# PE19061, Lot # 030804-NR, Aug 2007 expiration
Model NR4000PA-C (size 5 mm), serial# PE19089, Lot # 030924-NR, Sept 2007 expiration
Model NR4000PA-C (size 6 mm), serial# PE20073, Lot # 040903-NR, Sept 2008 expiration
Model NR4000PA-C (size 5 mm), serial# PE20678, Lot # 050222-NR, Feb 2009 expiration
Model NR4000PA-C (size 6 mm), serial# PE20388, Lot # 050103-NR, Jan 2009 expiration
Model NR4000PA-C (size 5 mm), serial# PE20677, Lot # 050222-NR, Feb 2009 expiration
RECALLING FIRM/MANUFACTURER
Shelhigh, Inc., Union, NJ, by telephone on January 18, 2006, firm initiated recall is complete.
REASON
Unapproved Device-Distribution of an unapproved device into interstate commerce.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
MA, AZ, and Italy

______________________________
PRODUCT
a) Baxter BM25 System ultrafiltration hemodialysis machine;
The BM25 System is composed of a BM11A Blood Monitor Pump
(5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module
(5M3052/5M3052R), with a cart with scales (5M3053);
product code GEF042-10 in China, Recall # Z-0679-06;
b) Baxter BM11A Blood Monitor Pump hemodialysis machine;
product code 5M3051, 5M3051R, Recall # Z-0680-06;
c) Baxter BM11 Blood Monitor Pump hemodialysis machine;
product code 5M3005, 5M3005R, Recall # Z-0681-06
CODE
All Serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by letters dated December 21, 2005.
Manufacturer: Mesys Gmbh. Hannover. Germany, firm initiated recall is ongoing.
REASON
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM 11/BM 11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.
VOLUME OF PRODUCT IN COMMERCE
1,249 units
DISTRIBUTION
Nationwide, Colombia, Hong Kong and China

______________________________
PRODUCT
a) Brand Name: RapidLab 1200 System, Model 1240,
Part Number 05060298; All RapidLab 1200 Systems with
Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases,
electrolyte and blood pH test system, Recall # Z-0682-06;
b) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0683-06;
c) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0684-06;
d) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0685-06
CODE
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by E-mails on January 20, 2006.
Manufacturer: Bayer Healthcare, LLC (Diagnostics Division), Norwood, MA, firm initiated recall is ongoing.
REASON
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
VOLUME OF PRODUCT IN COMMERCE
515 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Tooth bonding resin. Optibond Solo Plus,
Part number 31513, Recall # Z-0686-06;
b) Tooth bonding resin. Optibond Solo Plus Bottle Kit,
Part number 31514, Recall # Z-0687-06;
c) Tooth bonding resin. Optibond Solo Plus Dual Cure Kit,
Part number 31736, Recall # Z-0688-06;
d) Tooth bonding resin. Nexus 2 Kit,
Part number 31954, Recall # Z-0689-06;
e) Tooth bonding resin. Nexus 2 Starter Kit,
Part number 31955, Recall # Z-0690-06;
f) Tooth bonding resin. Premise Master Syringe Kit,
Part number 32611, Recall # Z-0691-06;
g) Tooth bonding resin. Premise Master Unidose Kit,
Part number 32612, Recall # Z-0692-06;
h) Tooth bonding resin. Premise Starter Unidose Kit,
Part number 32684, Recall # Z-0693-06
CODE
a) Lot numbers: 427936. 428569, and 428290;
b) Lot number: 429106;
c) Lot number: 427793;
d) Lot number: 428572;
e) Lot numbers: 428570 and 429640;
f) Lot number: 428730;
g) Lot number: 428576;
h) Lot number: 427915
RECALLING FIRM/MANUFACTURER
Kerr Corporation, Orange, CA, by letters on March 3 and 6, 2006, firm initiated recall is ongoing.
REASON
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
VOLUME OF PRODUCT IN COMMERCE
7,320 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT110, Recall # Z-0694-06;
b) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT111, Recall # Z-0695-06;
c) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT210, Recall # Z-0696-06;
d) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT211, Recall # Z-0697-06
CODE
Affected lots for all catalogue numbers: 041101-050331 (inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December 20, 2005.
Manufacturer: Fisher and Paykel Ltd., Auckland, New Zealand, firm initiated recall is ongoing.
REASON
Risk of fire, The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
VOLUME OF PRODUCT IN COMMERCE
5,475 boxes (54,750 pcs)
DISTRIBUTION
Nationwide and Internationally

 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Osteofil + RT Allograft Paste 10cc. SINGLE PATIENT USE ONLY,
Recall # Z-0698-06;
b) Osteofil Allograft, 5cc, SINGLE PATIENT USE ONLY, Recall # Z-0699-06;.
c) Osteofil Allograft Paste (Bio) of varying sizes, SINGLE PATIENT USE ONLY,
Recall # Z-0700-06;
d) Osteofil IC Syringeable of varying sizes. SINGLE PATIENT USE ONLY,
Recall # Z-0701-06;
e) Osteofil ICM Moldable Strip of varying sizes. SINGLE PATIENT USE ONLY,
Recall # Z-0702-06;
f) Osteofil RT, ICM Allograft Paste in varying sizes. SINGLE PATIENT USE ONLY,
Recall # Z-0703-06
CODE
a) 1766813 1766814 1890442 1890445 1890446 1890447 1890450
1890451 1938863 1938864 1938865 1938868 1938869 1890448
1890449 1938862 1938866 1938870;
b) 1678712 1678713 1678714 1678715 1678716 1678718 2086922
2086924 2086925 2115381 2115382 2115383 2115384 2115385
2115387 2115388 2115389 2115390 2116581 2116582 2116585
2116586 2116587 2116588 2116589 2116590 2116762 2116764
2116766 2116767 2116768 2116771 2116892 2116893 2116894
2116895 2116896 2116897 2116898 2116899 2116900 2116901
1678711 1678717 1678719 1678720 2086921 2086923 2115386
2116583 2116584 2116763 2116765 2116769 2116770;
c) 1760901 1760902 1760903 1760905 1760906 1760907 1760908
1760909 1765751 1765752 1765753 1765754 1765755 1765756
1765759 1765760 1765781 1765782 1765783 1765784 1765785
1765787 1765789 1776411 1776413 1776414 1776415 1776417
1776418 1776419 1776420 1793211 1793212 1793215 1793217
1793218 1793219 1793220 1793462 1793463 1793464 1793465
1793466 1793467 1793468 1793469 1793470 1827001 1827002
1827003 1827004 1827006 1827008 1827009 1827010 1827311
1827312 1827313 1827314 1827316 1827318 1827319 1827320
1760904 1765757 1765758 1765786 1765788 1765790 1776412
1776416 1793213 1793214 1793216 1793461 1827005 1827007
1827315 1827317 1672181 1672182 1672183 1672184 1672185
1672186 1672187 1672188 1672190 1672241 1672243 1672244
1672245 1672247 1672248 1672249 1672250 1672393 1672394
1672395 1672397 1672400 1672431 1672433 1672434 1672435
1672436 1672438 1672439 1672471 1672473 1672474 1672475
1672476 2185771 2185773 2185775 2185961 2185963 2185964
2185965 2185966 2185967 2185968 2185970 2197196 2197197
2197198 2197199 2197200 2197201 2197202 2197203 2197484
2197485 2197487 2197488 2197489 2197491 2197493 1672189
1672242 1672246 1672396 1672432 1672437 1672440 1672472
2185772 2185962 2185969 2197194 2197195 2197486 2197490
2197492 2141130 2141132 2141133 2141134 2141135 2141137
2141138 2141139 2141140 2141141 2141143 2141144 2141145
2250214 2250215 2250216 2250218 2250219 2250220 2250221
2250223 2250224 2250225 2250226 2250227 2250228 2250229
2250232 2250233 2250234 2250235 2250236 2250237 2250240
2250261 2250262 2250263 2250264 2250265 2517551 2517556
2517557 2522091 2522098 2522099 2141127 2141128 2141129
2141131 2141136 2141142 2250212 2250213 2250217 2250222
2250230 2250231 2250238 2250239 2517552 2517553 2517554
2517555 2517558 2517559 2517560 2521551 2521552 2521553
2521554 2521555 2521556 2522092 2522093 2522094 2522095
2522096 2522097 2522100;
d) 2185721 2185722 2185723 2185726 2185727 2185728 2185941
2185942 2185943 2185947 2185949 2185950 2250244 2185724
2185725 2185729 2185730 2185944 2185945 2185946 2185948
2141102 2141104 2141106 2141107 2141108 2141109 2141111
2141112 2141113 2141114 2141115 2141116 2141118 2141119
2141120 2141122 2141123 2141124 2141125 2141126 2157937
2157938 2157939 2157940 2157941 2157943 2157944 2157945
2141103 2141105 2141110 2141117 2141121 2157942 2157946
2250241 2250242 2250243;
e) 1662221 1662222 1662224 1662225 1662226 1662228 1662229
1662230 1672261 1672262 1672263 1672264 1672265 1672266
1672267 1672268 1672269 1672270 2085436 2091131 2091132
2091133 2091135 2091136 2091137 2091138 2091140 2094702
2094703 2094704 2094705 2094706 2094709 2207921 2207922
2207925 2207926 2207927 2207930 2724041 2724042 2724043
2724045 2724048 1662223 2091134 2091139 2094701 2094707
2094708 2094710 2207923 2207924 2207928 2207929 2724040
2724044 2724046 2724047 2193437 2193438 2193439 2197304
2197305 2197307 2197308 2197309 2197310 2197311 2197313
2290771 2290772 2290774 2290775 2290776 2290777 2290778
2290779 2290780 2291312 2291313 2291314 2291315 2291316
2291317 2291319 2291320 2774214 2774217 2774218 2193436
2197306 2197312 2290773 2291311 2291318 2774213 2774215
2774216;
f) 2014947 2014949 2014952 2014953 2014954 2091152 2091153
2091154 2326261 2326262 2326263 2326265 2326267 2326268
2326269 2326270 2326761 2326762 2326764 2326767 2326769
2326770 2326801 2326802 2326803 2326804 2326805 2326806
2326806 2326807 2326808 2326809 2389440 2395012 2395013
2395014 2395015 2395016 2395017 2395018 2395019 2014945
2014946 2014948 2014950 2014951 2091151 2326264 2326763
2326765 2326766 2326810 2395011 2395020 2171680 2171681
2171682 2171683 2171684 2171685 2171686 2171687 2171688
2171690 2171692 2171693 2171694 2171695 2171696 2171697
2171698 2171700 2171702 2171703 2171704 2171705 2171706
2171707 2171708 2171709 2171710 2171711 2171712 2171713
2171689 2171691 2171699 2171701
RECALLING FIRM/MANUFACTURER
Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005, firm initiated recall is ongoing.
REASON
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
VOLUME OF PRODUCT IN COMMERCE
554 units
DISTRIBUTION
TN

 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

_______________________________
PRODUCT
a) Diamond Pet Foods * Low-Fat * Formula
for Adult Dogs * Formulated for the
Health of Inactive or Overweight Adult
Dogs * Net Wt. 35 LGS. (15.87kg),
Recall # V-020-6;
b) Diamond Pet Foods * Hi-Energy Sporting
Formula * Exclusively formulated for
Sporting Dogs * Net Wt. 50 LBS (22.68 kg),
Recall # V-021-6;
c) Diamond Pet Foods * Maintenance for Adult
Dogs * Net Wt. 50 LBS. (22.68 kg),
Recall # V-022-6;
d) Diamond Pet Foods * Performance for Adult
Dogs * 20 LBS, Recall # V-023-6;
e) Diamond Pet Foods * Puppy * For the Special
Needs of Puppies and Gestating Lactating
Adult Dogs * Net Wt. 40 LBS. (18.14 kg),
Recall # V-024-6;
f) Diamond Pet Foods * Maintenance for Adult
Cats * Formulated to Help Maintain Optimum
Health of Your Cat * Net Wt. 20 LBS (9.07 kg),
Recall V-025-6;
g) Diamond Pet Foods * Professional for Cats *
Net Wt. 20 LBS (9.07 kg), Recall # V-026-6;
h) Country Value * Puppy * Wholesome Nutrition
for Dogs * Puppy Formula * Omega Fatty Acid
Balanced * Net Wt. 40 LBS (18.14 kg),
Recall # V-027-6;
i) Country Value * Adult Dog * Wholesome Nutrition for
Dogs * Adult Dog Formula * 100% Complete and Balanced
for Maintenance * Net Wt. 50 lbs. (22.5 kg),
Recall # V-028-6;
j) Country Value * Wholesome Nutrition for Dogs *
High Energy * Dog Formula * Net Wt. 50 lbs
(22.6 kg), Recall # V-029-6;
k) Country Value * Adult Cat Food * Cat Formula *
Contains Chelated Minerals * Taurine Fortified *
Net Wt. 20 lbs (9.07kg), Recall # V-030-6;
l) Professional * The Science of Complete and Balanced Pet Nutrition *
Senior Dog * Chicken & Rice Formula * Net W6. 18 lbs (8.16 kg),
Recall # V-031-6;
m) Professional * The Science of Complete and Balanced Pet Nutrition *
Adult Dog * Rice & Chicken Low-Fat Formula * Net Wt. 18 lbs (8.16kg),
Recall # V-032-6;
n) Professional * The Science of Complete and Balanced Pet Nutrition *
Adult Dog * Chicken & Rice Formula * Net W6. 18 lbs (8.16 kg),
Recall # V-033-6;
o) Professional * The Science of Complete and Balanced Pet Nutrition, *
Large Breed Puppy Food * Chicken & Rice Formula * Net W6. 35 lbs (15.87 kg),
Recall # V-034-6;
p) Professional * The Science of Complete and Balanced Pet Nutrition *
Puppy * Chicken & Rice Formula * Net W6. 18 lbs (8.16 kg), Recall # V-035-6;
q) Professional * The Science of Complete and Balanced Pet Nutrition *
Adult Cat * Chicken & Rice * Reduced-Fat Formula * Net Wt. 18 lbs (8.16kg),
Recall # V-036-6;
r) Professional * The Science of Complete and Balanced Pet Nutrition, *
Adult Cat * Chicken & Rice Formula * Net Wt. 18 LBS, Recall # V-037-6;
s) Nutra Nugget Maintenance Dog (International brand), Recall # V-038-6;
t) Nutra Nugget Performance Dog (International brand), Recall # V-039-6;
u) Nutra Nugget Lite (International brand), Recall # V-040-6;
v) Nutra Nugget Professional Dog (International brand), Recall # V-041-6;
w) Nutra Nugget Professional Cat (International brand), Recall # V-042-6;
x) Nutra Nugget Puppy (International brand), Recall # V-043-6;
y) NutraGold Puppy (International brand), Recall # V-044-6;
z) NutraGold Large Breed Puppy (International brand), Recall # V-045-6;
aa) NutraGold Adult Dog (International brand), Recall # V-046-6;
bb) NutraGold Large Breed Adult (International brand), Recall # V-047-6;
cc) NutraGold Senior (International brand), Recall # V-048-6;
dd) Diamond Professional for Adult Dogs (this is a discontinued product,
however a sample taken by the NC Dept of Agriculture tested positive
for aflatoxin), Recall # V-049-6;
ee) Diamond Pet Foods * Premium Adult for Dogs * Formulated to Help
Maintain Strength and Stamina * Net Wt. 40 LBS. (18.14kg), Recall # V-050-6
CODE
a) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: DLT 0901F,
DLT 0901H;
b) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: DSD 091R,
DSD 091A, DSD 091B, DSD 091E, DSD 0901F,
DSD 0901G, DSD 0901H, SD 0901K, DSD 0901L,
DSD 0901N, DSD 0901O, DSD 0901P, DSD 0901Q,
DSD 901R, DSD 1001L, DSD 09010, DSD 0901I,
DSD 1001E, DSD 1001J, DSD 1101E, DSD 1101P,
DSD 1101Q, DSD 1201E, DSD 1201G, DSD 1201H,
DSD 901H;
c) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th or
12th digit "G". Batch Code: DMD 0901C,
DMD 0901E, DMD 0901G, DMD 0901H, DMD 0901I,
DMD 0901J, DMD 0901K, DMD 0901L, DMD 0901M,
DMD 0901N, DMD 0901O, DMD 1001E, DMD 1001Q,
DMD 1001R, DMD 1101E, DMD 1101G, DMD 0801D,
DMD 0801P, DMD 0901O, DMD 0901H, DMD 0901I,
DMD 0901J, DMD 0901L, DMD 0901N, DMD 1001A,
DMD 1001G, DMD 1001I, DMD 1001J, DMD 1001L,
DMD 1001O, DMD 1001Q, DMD 1001R, DMD 1001S,
DMD 1101E, DMD 1101F, DMD 1101G, DMD 1101H,
DMD 1101J, DMD 1101P, DMD 1201E, DMD 1201G,
DMD 1201H;
d) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07".with an 1th or
12th digit "G". Batch Code: PCU 0901E,
PCU 0901F, PCU 0901G, PCU 0901H, PCU 1001F,
PCU 1101J, PCU 1201E;
e) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th or
12th digit "G". Batch Code: DPP 0901E,
DPP 0901F, DPP 0901G, DPP0901I, DPP 0901J,
DPP 0901L, DPP 0901M, DPP 1001B, DPP 1001J,
DPP 1001L, DPP 1001M, DPP 1001N, DPP 0901W,
DPP 1001L, DPP1001M, DPP1001M, DPP 1001N,
DPP 1201F;
f) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: DMC 0901E,
DMC 0901F, DMC 0901E, DMC 1001E, DMC 1101J;
g) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: DPD 0901G;
h) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: CVH 1001F;
i) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G". Batch Code: CVD1001F,
CVD 1001K, CVD 1101L, CVD 1201E, CVD 1201F,
CVD 1201H;
j) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th or
12th digit "G". Batch Code: CVH 1001F, CVH1201E;
k) Affected date codes: "Best By 01-March 07"
through Best By "10-June-07", with an 1th
or 12th digit "G";
l) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G". Batch Code: PSC 1201E
m) Affected date codes: "Best By 01-March 07"through Best By "10-June-07" ,
with an 1th or 12th digit "G". Batch Code: PCR1201E;
n) Affected date codes: "Best By 01-March 07"through
Best By "10-June-07", with an 1th or 12th digit "G";
o) Affected date codes: "Best By 01-March 07"through
Best By "10-June-07", with an 1th or 12th digit "G',
Batch Code: PLP 1101H, PLP 1201E;
p) Affected date codes: "Best By 01-March 07"through
Best By "10-June-07", with an 1th or 12th digit "G";
q) Affected date codes: "Best By 01-March 07"through
Best By "10-June-07", with an 1th or 12th digit "G";
r) Affected date codes: "Best By 01-March 07"through
Best By "10-June-07", with an 1th or 12th digit "G";
s) Best Before dates between March 01, 2007 and June 10, 2007;
t) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
u) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
v) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
w) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
x) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
y) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
z) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
aa) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
bb) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
cc) Affected date codes: "Best By 01-March 07"through Best By "10-June-07",
with an 1th or 12th digit "G";
dd) Best By date of January 29, 2007;
ee) Affected date codes: "Best By 01-March 07"through Best By "10-June-07"
The eleventh or twelfth character in the date code will be a capital "G"
(in reference to Gaston). Batch Code: DPA 0901H, DPA 0901I, DPA 0901M,
DPA 0901N, DPA 1001I, DPA 1001J, DPA 1001K, DPA 1001L,
DPA 1001M, DPA 1001N, DPA 0901F, DPA 0901H, DPA 0901I,
DPA 0901M, DPA 0901N, DPA 1001M, DPA 1101E, DPA 1101F,
DPA 1101G, DPA 1101H, DPA 1101K, DPA 1101L, DPA 1101M,
DPA 1101N, DPA 1101O, DPA 1101P, DPA 1101R, DPA 1101S,
DPA 1200F, DPA 1201E, DPA 1201F, DPA 1201F, DPA 1201G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamond Pet Foods, Meta, MO, by press release and letter on December 21, 2005.
Manufacturer: Diamond Pet Foods of SC, Gaston, SC, firm initiated recall is ongoing.
REASON
Product was found to contain Aflatoxin
VOLUME OF PRODUCT IN COMMERCE
790,423 units
DISTRIBUTION
Nationwide and Internationally

 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Factrel Gonadorelin Hydrochloride, 50 mcg/mL Sterile Solution, packaged in 20-ml multi-dose vials, each ml contains 50 mcg gonadorelin (as hydrochloride), RX, NADA 139-237, NDC 0856-4311-02, packaged under the following labels: Fort Dodge Animal Health, and the Ayerst Veterinary Laboratories, Div. of Wyeth-Ayerst Canada, Inc. The product is also packaged for export under the Ayerst Factrel label in 50-mL multi-dose vials, Recall # V-064-6
CODE
Lot 431341, Exp Oct-07; Lot 431342, Exp Oct-07 (both Fort Dodge and Ayerst labels in the 20-ml. vial).; Lot 431343, Exp Nov-07; Lot 431344, Exp Nov-07 (50-mL Ayerst label); Lot 431345, Exp Jan-08; Lot 431346, Exp Jan-08; Lot 431347, Exp Jan-08 (50 mL Ayerst label); Lot 431348, Exp Feb-08; Lot 431349, Exp Feb-08; Lot 431351, Exp Apr-08; Lot 431353, Exp Jul-08; Lot 431354, Exp Jul-08; Lot 431355, Exp Aug-08
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by E-mail on January 19, 2006 and by letter dated January 20, 2006, firm initiated recall is ongoing.
REASON
Out of specification or out of trend assay results for gonadorelin.
VOLUME OF PRODUCT IN COMMERCE
181,331/20-ml vials and 13,625/50-ml vials
DISTRIBUTION
Nationwide, Canada, Mexico, the Netherlands, and the West Indies

 

END OF ENFORCEMENT REPORT FOR APRIL 5, 2006

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