Enforcement Report

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.

rule

December 26, 2007
07-52

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Queseria Mexico brand Queso Fresco - Fresh White Cheese, Net Wt. 14 oz., Ingredients: Pasteurized Whole Milk, Rennet, Salt, and Vinegar. The cheese is packaged in a sealed, foil bag. Plant No. 36-7845, Recall # F-062-8
CODE
Code 1616 (found on white sticker label)
RECALLING FIRM/MANUFACTURER
Quesos Mexico LLC, Brooklyn, NY, by telephone on October 5, 2007. NY initiated recall is complete.
REASON
The cheese was found to be contaminated with Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
700 - 14 oz. units
DISTRIBUTION
NY and NJ
___________________________________
PRODUCT
ALDER SMOKED SALMON, 2 lb vacuum packed plastic bags, consisting of salmon trim, labeled ALDER SMOKED SALMON KEEP FROZEN OR REFRIGERATED AT 38F OR BELOW. Product packed 13/2 lb. packages/case, Recall # F-063-8
CODE
Lot numbers: 02927 and 01427
RECALLING FIRM/MANUFACTURER
Salmolux Inc, Federal Way, WA, by telephone on November 2, 2007 and November 5, 2007. Firm initiated recall is complete.
REASON
Product potentially contaminated with Listeria monocytogenes
VOLUME OF PRODUCT IN COMMERCE
3,738 lbs.
DISTRIBUTION
TN and CA
___________________________________
PRODUCT
President's Choice Chocolate Chunk Brownie Cookies, Net Wt. 12 oz. (340 g), UPC 0 41360 00830 5, Product of Canada, Recall # F-064-8
CODE
Lot: 03 22 08 N
RECALLING FIRM/MANUFACTURER
A&M Cookie Company Canada, Kitchener, Canada, by press release on October 26, 2007. Firm initiated recall is ongoing.
REASON
President's Choice Chocolate Chunk Brownie Cookies contain an undeclared allergen, milk, present as a sub-ingredient of a natural flavor. Persons who have an allergy or severe sensitivity to milk run the risk of possible allergic reactions if they consume these cookies.
VOLUME OF PRODUCT IN COMMERCE
876 cases (12 retail units per case)
DISTRIBUTION
MI, IA, IL, IN, WI, MN
___________________________________
PRODUCT
Chocolate Jalapeno Glass Dessert Cup, Net Wt. 4.2 oz, UPC 0020981000000, Harris Teeter. This product is a dessert product sold under refrigeration in a glass cup with a plastic lid and the cup with lid is placed in a plastic clam shell and then displayed in the self service bakery case, Recall # F-083-8
CODE
The product displayed for retail sale does not have lot numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harris Teeter, Matthews, NC, by press release and email on October 17, 2007.
Manufacturer: Bindi, Milano, Italy. Firm initiated recall is complete.
REASON
Undeclared allergens: soy, wheat, and hazelnuts.
VOLUME OF PRODUCT IN COMMERCE
108 cases
DISTRIBUTION
DE, FL, GA, MD, NC, SC, TN and VA
___________________________________
PRODUCT
Hickory or Homestyle Hickory Barbeque Sauce packaged in 19 ounce jars and bearing the following brand names: Andy T's Farms; Bailey's Fresh Off the Farm; Coleman's Farm Market; Fruit Acres Farm Market; Galen's Own Brand; Heritage Gardens; Jenny's Farm Stand; Little Store on the Prairie; Palmbos Farm Market; Sevick Gardens: Yoder's Country Market; Dutch Country Market; Grandma's Goodies; Grandma's Pantry; Grant Line Nursery & Garden Center; Parcell's Pantry; Sandy's, Made For: Creative Workshop; The Madison Fudge Factory; Yoder's Meat & Cheese Co; Chefworld Seasonings; J.P. Little Seasonings; Heller's Farm; Indian Pines Farm Market; Hartrich Meats, Inc.; Yaeger's; Mystic Ridge Alpacas; Smoky Mountain Mercantile; Apple Shack; Van's Fruit Market; Red Apple Barn; Harvest Barn; Amish Country Store; Andersen Farms; S&R Farm Market; MoonShadows Farm, and Windmill Farms Grain & Garden, Recall # F-084-8
CODE
Lots: HI710530W and SM710905W
RECALLING FIRM/MANUFACTURER
Dutch Kettle, Bremen, IN, by press release on October 30, 2007 and by fax on October 29, 2007. Firm initiated recall is complete.
REASON
The product contains undeclared fish protein (anchovies).
VOLUME OF PRODUCT IN COMMERCE
1,128 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Sun Kee Dried Sweet Potato; Net Wt. 12 oz (340 g 5 g); Product of China, UPC 4740602137 USA, Recall # F-085-8
CODE
No codes are listed.
RECALLING FIRM/MANUFACTURER
Prosperity Resources International Inc., Irvington, NJ, by letters on July 5, 2007, press release on July 10, 2007 and by telephone on July 17, 2007. Firm initiated recall is complete.
REASON
The New York State Department of Agriculture and Markets sampled product and found it to contain 1018 ppm of sulfites, which were not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
20 cases of 24 X 12 oz. packages
DISTRIBUTION
NY, IL, MA, OH and PA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Guar Gum packed in 50 lb paper bags, Recall # F-065-8
CODE
Lot #’s: RG1255/07/612 and RG255/07/613
RECALLING FIRM/MANUFACTURER
Recalling Firm: Multi-Kem Corporation, Ridgefield, NJ, by telephone and e-mail beginning on September 28, 2007.
Manufacturer: Rama Industries, Deesa, India. Firm initiated recall is ongoing.
REASON
Metal wire and pieces of wood in bags of the product.
VOLUME OF PRODUCT IN COMMERCE
12,000 pounds
DISTRIBUTION
CA and CO
___________________________________
PRODUCT
Tugusto Adobo Pavochon, UPC # 7 55009 91950 0 UPC # 7 55009 52669 2, Recall # F-066-8
CODE
There were no lot numbers.
RECALLING FIRM/MANUFACTURER
Tugusto Foods, Inc. Bayamon, PR, by fax on November 15, 2007. FDA initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow # 5 and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
220 units of 7 lbs. and 780 units of 2 lbs
DISTRIBUTION
PR
___________________________________
PRODUCT
Chocolate Ambateno, Product of Ecuador Net Wt. 7 oz. (200 g), Recall # F-067-8
CODE
Lot # 1401, Exp 3/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fabi-Saa Inc., Newark, NJ, by letters on November 6, 2007.
Manufacturer: Pequeno Industria Ecuatoriana, Ambato, Ecuador. Firm initiated recall is ongoing.
REASON
Product contains undeclared sugar.
VOLUME OF PRODUCT IN COMMERCE
35 cases of 24x7 oz bars.
DISTRIBUTION
NJ, NY, MA and PA
___________________________________
PRODUCT
a) Organic Unsalted Crunchy Peanut Butter, packaged in 11.5 oz (322 g) clear glass jar
with metal screw lid. Label includes: "Kettle brand Roaster Fresh Crunchy Unsalted
Organic Peanut Butter", UPC 084114 020758, Recall # F-068-8;
b) Organic Unsalted Creamy Peanut Butter, packaged in 11.5 oz (322 g) clear glass jar
with metal screw lid. Label includes: "Kettle brand Roaster Fresh Creamy Unsalted
Organic Peanut Butter", UPC 084114 020765, Recall # F-069-8
CODE
a) and b) Best before date code (month/day/year) 082808
RECALLING FIRM/MANUFACTURER
Kettle Foods, Salem, OR, by telephone, email or fax on November 8, 2007. Firm initiated recall is complete.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
680 cases (8,160 jars)
DISTRIBUTION
Nationwide and Canada, Vietnam and the Philippines
_________________________________
PRODUCT
a) Nazook - a mildly sweet Armenian pastry, Packaged in a clear plastic clam shell,
Net wt. 20 oz. Label includes “Preservative Free Hand Made Eurobake European
Bakery Nazook TM Great for Breakfast! Nazook is a mildly sweet American pastry”,
Recall # F-074-8;
b) Baklava - traditional Greek style with Honey Syrup, Packaged in a clear plastic
clam shell, Net wt. 18 oz. 511 g. Label includes “Preservative Free Hand Made
Eurobake European Bakery Traditional Baklava Traditional Greek Style with
Honey Syrup to keep Moistness”, Recall # F-075-8;
c) Sweet Blueberry Rolls, Packaged in a clear plastic clam shell, Net wt. 20 oz.
Label includes “Preservative Free Hand Made Eurobake European Bakery Sweet
Blueberry Rolls Great For Breakfast!”, Recall # F-076-8
d) Gata TM. Packaged in a clear plastic bag, Net wt. 16 oz. (1 lb) 454 g. Label
includes “Preservative Free Hand Made Eurobake European Bakery Gata TM
Sweet Bread, Pronounced “Katta,” Gata is the original form of Nazook except the
filling is baked inside the dough for a different flavor”, Recall # F-077-8;
e) Hawaiian Sweet Blueberry Bread. Packaged in a clear plastic bag, Net wt. 18 oz.
(1 lb. 2 oz.) Label includes “Preservative Free Hand Made Eurobake European
Bakery Hawaiian Sweet Blueberry Bread, A mildly sweet dough filled with
Blueberries baked to perfection”, Recall # F-078-8
f) Sweet Raisin Bread. Packaged in a clear plastic bag, Net wt. 19 oz. (1 lb. 3 oz.)
539 g. Label includes “Preservative Free Hand Made Eurobake European Bakery
Sweet Raisin Bread, mildly sweet dough filled with raisins baked to perfection”,
Recall # F-079-8;
g) Powdered Walnut Rolls. Packaged in a clear plastic clam shell, Net wt. 14 oz. 397 g.
Label includes “Preservative Free Hand Made Eurobake European Bakery
Powdered Walnut Rolls, A Greek Favorite, A mildly Sweet Greek Cookie Great
with Coffee and Tea”, Recall # F-080-8
CODE
a) SELL BY date code 11/6/07 and prior. Codes are located on the label, lower right
hand quadrant;
b) SELL BY date code 12/11/07 and prior. Codes are located on the label, lower right
hand quadrant;
c) thru g) SELL BY date code 11/6/07 and prior. Codes are located on the label, lower
left hand quadrant
RECALLING FIRM/MANUFACTURER
Eurobake Corp., Portland, OR, by letter on October 17, 2007. Firm initiated recall is complete.
REASON
Products contain undeclared milk, wheat, and color additives – FD&C Red #40 and FD&C Blue #2.
VOLUME OF PRODUCT IN COMMERCE
26,434 units
DISTRIBUTION
CA, ID, NV, OR, and WA.
___________________________________
PRODUCT
a) Chipper With Coffee Biscotti, Apple Cinnamon; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGACNB; The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-086-8;
b) Chipper With Coffee Biscotti, Apricot Almond; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGAAB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-087-8;
c) Chipper With Coffee Biscotti, Banana Walnut; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGBWB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-088-8;
d) Chipper With Coffee Biscotti, Chocolate Chip; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGCCB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-089-8;
e) Chipper With Coffee Biscotti, Chocolate Raspberry; 1.75 ounce clear plastic bag
with hang tag, 12 bags per case; item #CGCRB The biscotti were also sold under
item CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-090-8;
f) Chipper With Coffee Biscotti, Classic Almond; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGAB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-091-8;
g) Chipper With Coffee Biscotti, Cranberry Orange; 1.75 ounce clear plastic bag
with hang tag, 12 bags per case; item #CGCOB The biscotti were also sold under
item CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-092-8;
h) Chipper With Coffee Biscotti, German Chocolate; 1.75 ounce clear plastic bag
with hang tag, 12 bags per case; item #CGGCB; The biscotti were also sold under
item CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-093-8;
i) Chipper With Coffee Biscotti, Maple Pecan; 1.75 ounce clear plastic bag with hang
tag, 12 bags per case; item #CGMPB; The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-094-8;
j) Chipper With Coffee Biscotti, Maple Walnut; 1.75 ounce clear plastic bag with hang
tag, 12 bags per case; item #CGMWB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-095-8;
k) Chipper With Coffee Biscotti, Mocha Chip; 1.75 ounce clear plastic bag with hang
tag, 12 bags per case; item #CGMCB; The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-096-8;
l) Chipper With Coffee Biscotti, Pistachio Orange; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGPOB; The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-097-8;
m) Chipper With Coffee Biscotti, Snickerdoodle; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGCSB The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-098-8;
n) Chipper With Coffee Biscotti, Triple Chocolate; 1.75 ounce clear plastic bag with
hang tag, 12 bags per case; item #CGTCB; The biscotti were also sold under item
CGBAST1, which consisted of 8 cases of an assortment of the flavors,
Recall # F-099-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coffee Masters, Spring Grove, IL, by telephone on October 18/19, 2007 by letters on October 19, 2007 and by press release on November 13, 2007.
Manufacturer: Chipper Gourmet Foods Inc., McHenry, IL. Firm initiated recall is ongoing.
REASON
Products do not bear ingredient statements.
VOLUME OF PRODUCT IN COMMERCE
26,556 packages
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
a) Wawa Strawberry Enhanced Spring Water in 20 oz bottles, Recall # F-070-8;
b) Wawa Mixed Berry Enhanced Spring Water in 20 oz bottles, Recall # F-071-8;
c) Wawa Grape Enhanced Spring Water in 20 oz bottles, Recall # F-072-8;
d) Wawa Lemon Enhanced Spring Water in 20 oz bottles, Recall # F-073-8
CODE
a) Sell by 7/11/2008, 7/19/2008, 8/21/2008, and 8/27/2008;
b) Sell by 7/11/2008, 7/25/2008, 8/8/2008, 9/12/2008, and 9/24/2008;
c) Sell by 7/11/2008, 7/25/2008, and 8/27/2008;
d) Sell by 7/8/2008, 7/11/2008, 7/19/2008, 8/8/2008, and 9/12/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wawa, Inc., Media, PA, by email, on October 1, 2007.
Manufacturer: Fox Ledge, Inc., Honesdale, PA. Firm initiated recall is complete.
REASON
Beverages are off-taste due to mold growth.
VOLUME OF PRODUCT IN COMMERCE
488,472 bottles
DISTRIBUTION
DE, MD, NJ, PA, and VA
___________________________________
PRODUCT
Your Life Daily Pak Maximum Multivitamin-30 Days, SKU#: 074970016804, UPC#: 74970016804, LHP Part #: 6B1680L, Recall # F-081-8
CODE
Lot Number: 7ED0395
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products Llc, Carson, CA, by letters dated October 25, 2007.
Manufacturer: Leiner Health Products Llc, Garden Grove, CA. Firm initiated recall is ongoing.
REASON
Product lot was incorrectly packaged with one instead of two Vitamin C caplets in each packet
VOLUME OF PRODUCT IN COMMERCE
11,982 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Nature Made 130 Count Vitamin C 500 mg with Rose Hips, List 1259A, UPC 31604 11259, Recall # F-082-8
CODE
Lot # RG10867
RECALLING FIRM/MANUFACTURER
Pharmavite Corporation, Northridge, CA, by letter and e-mail on August 21, 2007. Firm initiated recall is ongoing.
REASON
One lot of Nature Made Cod Liver Oil contains some bottles mislabeled as Nature Made Vitamin C 500 mg with Rose Hips.
VOLUME OF PRODUCT IN COMMERCE
25,752
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stop & Shop Salted Roasted Almonds, New wt. 32 oz. (2 lbs.), Recall # F-100-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Stop and Shop Supermarket Company, LLC, Quincy, MA, by email on December 4, 2007.
Manufacturer: Bremner Food Group Dothan Facility, Dothan, AL. Firm initiated recall is complete.
REASON
Mislabeled: Product labeled as Almonds actually contains peanuts.
VOLUME OF PRODUCT IN COMMERCE
371 cases
DISTRIBUTION
CT, MA, NY, NJ and RI

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
a) True Man Sexual Energy Nutriment, Men’s formula, Natural Herbs, 10 Vege
Capsules, Recall # D-075-2008;
b) Energy Max Energy Supplement ® Men’s formula Natural Herbs, 20 Vege
Capsules, Recall # D-076-2008
CODE
Product with the expiration date up to and including December 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: America True Man Health, Inc., West Covina, CA, by letters on April 11, 2007, November 1, 2007, December 4 and 5, 2007 and by press release on May 10, 2007.
Manufacturer: H & L Industries, Inc., dba Natural Source Int’l, Inc. LaVerne, CA. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain various analogues of FDA-approved drugs used to treat erectile dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
Approx 28,958 blister packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Axcil Dietary Supplement Capsules, Phyto-Pharmaceutical Solutions for Male
Sexual Function, packaged in a blister pack of 15 capsules to a box,
Recall # D-077-2008;
b) Desirin Dietary Supplement Capsules, Phyto-Pharmaceutical Solutions for Female
Sexual Function, packaged in a blister pack of 15 capsules to a box,
Recall # D-078-2008
CODE
02/07 02B07 X02/10 (The code for Axcil and an additional product recalled, Desirin, are identical)
RECALLING FIRM/MANUFACTURER
TWC Global, LLC, Sunnyvale, CA by press release on September 12, 2007. Firm initiated recall is ongoing
REASON
Unapproved New Drug; product found to contain active pharmaceutical ingredients and analogs of FDA-approved drugs used to treat erectile dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
204 blister packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Anbesol Maximum Strength Liquid, Oral Anesthetic, Benzocaine 20%, 0.41 fl oz (12 mL), Recall # D-072-2008
CODE
Lots: B25020 and B65043, exp. 01/08
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letter on Aug. 31, 2007. Firm initiated recall is ongoing.
REASON
Product may be subpotent and may contain additional inactive ingredients than those listed in the Drug Facts panel, including FD&C Yellow 6.
VOLUME OF PRODUCT IN COMMERCE
226,728 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Phospholine Iodide (echothiophate iodide for opthalmic solution), 0.125%, 6.25mg/5 ml, Rx only, The package contains 1 bottle of sterile echothiophate iodide for ophthalmic solution with 40 mg potassium acetate (sodium hydroxide or acetic acid may have been incorporated to adjust pH during manufacturing), 1 bottle of sterile diluent (chlorobutanol), and 1 sterilized dropper for dispensing 5ml eye drops. NDC number 0046-1065-05, Recall # D-074-2008
CODE
Lot numbers 1076-55 (exp 04/08), 1076-56 (exp 04/08), 1076-57 (exp 11/08), 1057-58 (exp 12/08), and 1076-59 (exp 02/09).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letter on November 14, 2007.
Manufacturer: Chesapeake Biological Laboratories, Inc., Baltimore, MD. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, eye droppers were not subjected to radiation sterilization.
VOLUME OF PRODUCT IN COMMERCE
14,531 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
a) Nizatidine Oral Capsules, 300mg, 30 ea per bottle, Recall # D-070-2008;
b) Nizatidine Oral Capsules,150mg 60 ea per bottle, Recall # D-071-2008
CODE
a) Lot #: HE9893;
b) Lot #s: HE9914 and HE3513
RECALLING FIRM/MANUFACTURER
Apotex, Inc., Etobicoke, Canada, by e-mail and telephone on November 26, 2007. Firm initiated recall is ongoing.
REASON
Product failed stability test for related compounds.
VOLUME OF PRODUCT IN COMMERCE
32,123
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Capsicum Oleoresin, containing Capsaicin 0.025%. Topical Analgesic Cream, Net Wt. 2 oz. (57 grams), NDC 0182-5128-52, Recall # D-073-2008
CODE
Lot #: 60413 & 60417
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on November 8, 2007.
Manufacturer: Sheffield Laboratories, Div., of Faria Limited LLC, New London, CT. Firm initiated recall is ongoing.
REASON
Subpotent (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
34,484 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PREMPRO, conjugated estrogens/medroxyprogesterone acetate tablets, 0.3 mg/1.5 mg tablets in EZ-Dial dispenser, 3/28-tablet dispensers per carton, NDC 0046-0938-09, Rx only, Recall # D-079-2008
CODE
Lot: B67988, exp. 4/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters on December 12, 2007.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Product does not conform to the dissolution specifications for conjugated estrogens.
VOLUME OF PRODUCT IN COMMERCE
24,744 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0178-08;
b) Fresh Frozen Plasma (Apheresis), Recall # B-0179-08
CODE
a) and b) Units: 4821861
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on November 7, 2006.
Manufacturer: Oklahoma Blood Institute, Ponca City, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OK
______________________________________________________________________
PRODUCT
Data Innovations Instrument Manager Software versions 7.04.0001 through 8.04.03.01, Recall # B-0195-08
CODE
Software versions 7.04.0001 through 8.04.03.01
RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., South Burlington, VT, by e-mail on September 19, 2007 and by follow-up letter dated October 11, 2007. Firm initiated recall is ongoing.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1,500 units
DISTRIBUTION
Nationwide and Canada
______________________________________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0234-08
CODE
Units: GR57222; FQ68938
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on March 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0311-08
CODE
Unit: 2793646
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 16, 2007. Firm initiated recall is complete.
REASON
Blood product, which possibly contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
______________________________________________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0336-08
CODE
LL28574 (double unit)
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI, by telephone and letter dated May 15, 2007. 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
RI and MA
______________________________________________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0394-08;
b) Whole Blood Leukocytes Reduced, Recall # B-395-08
CODE
a) Unit: LS89596;
b) Unit: LJ05544
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on March 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
Platelets Pooled Irradiated, Recall # B-0396-08
CODE
Unit: KR10771
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on February 24, 2005. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0398-08
CODE
Units: 027GG27506, 027GG27510, 027KJ24564 and 027KJ24564
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on April 9, 2007 and by letter dated May 25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected using equipment that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WV and PA
______________________________________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0400-08
CODE
Units: 22FR08010, 22FR08004
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on April 12, 2007 and by letter dated April 25, 2007. Firm initiated recall is complete.
REASON
Blood products, for which there was incomplete documentation of the irradiation process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0401-08
CODE
Unit: FN14699
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on July 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0421-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0422-08;
c) Plasma Cryoprecipitated Reduced, Recall # B-0423-08
CODE
a) and b) Units: 22FN85220, 22FN80893;
c) Unit: 22FN85220
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter on June 12, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NJ, PA and WV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0426-08
CODE
Unit: FW93528
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone on January 24, 2005. Firm initiated recall is complete.
REASON
Blood product, returned due to possible hemolysis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0468-08
CODE
Unit: 22GH42185
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on June 6, 2007 and by letter dated June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a platelet unit that was contaminated with Streptococcus pyogenes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0469-08
CODE
Unit: 36LX14580
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by telephone on May 18, 2006 and by letter dated May 19, 2006. Firm initiated recall is complete.
REASON
Blood product, for which the documentation of irradiation was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0471-08
CODE
Unit: 1585560
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 15, 2005 or by email on July 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a rash, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0485-08;
b) Platelets, Recall # B-0486-08
CODE
a) and b) Unit: 2604483
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on November 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0487-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0488-08;
c) Plasma Cryoprecipitated Reduced, Recall # B-0489-08
CODE
a), b) and c) Units: 22GG03416
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile and electronic mail dated June 19, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA and CA
______________________________________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0490-08
CODE
Unit: 2133205
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on October 31, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
______________________________________________________________________
PRODUCT
Platelets, Recall # B-0498-08
CODE
Unit: 2658652
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 9, 2005 and by letter dated September 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received the oral typhoid vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
______________________________________________________________________
PRODUCT
Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 - April 4, 1999 to April 24, 2007 Product Code 936415F- Oct 26, 2005 to April 9, 2007 (F denotes refurbished), Recall # B-0156-08
CODE
Version 2.0.1
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, NJ, by letters on April 17, 2007. Firm initiated recall is ongoing.
REASON
The Sample Omission Monitoring (SOM) Calculations can be erroneous under very specific circumstances in which the Ortho Summit Sample Handling System (Summit) does not dispense Specimen Diluent into the A1 microwell of the assay plate.
VOLUME OF PRODUCT IN COMMERCE
230 units
DISTRIBUTION
Nationwide
______________________________________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0184-08
CODE
Unit: LK17622
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on February 25, 2006. Firm initiated recall is complete.
REASON
Blood product, lacking assurance of having been maintained at an acceptable temperature during shipping, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall B-0337-08
CODE
Units: 1955576 (split unit)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and letter on July 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall B-0397-08
CODE
Unit: FW96100
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc, Milwaukee, WI, by fax on June 3, 2005. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
a) Plasma Cryoprecipitated Reduced, Recall # B-0427-08;
b) Fresh Frozen Plasma, Recall # B-0428-08
CODE
a) Unit: FQ80563;
b) Units: LP72328; KL00077
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on February 8, 2005 and February 21, 2005. Firm initiated recall is complete.
REASON
Blood products, for which storage conditions and shipment information were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI
______________________________________________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0466-08
CODE
Unit: 22KP88763
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile and by letter dated May 25, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the C red cell antigen, but was collected from a donor who subsequently tested positive for C antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________________________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0467-08
CODE
Units: 22KJ59008, 22KK56829, 22GX95607
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated May 18, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as negative for the Fyb red cell antigen, but were collected from a donor who subsequently tested positive for Fyb antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ and PA
______________________________________________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0470-08
CODE
Unit: 2194024
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0472-08
CODE
Unit: 1585560
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 15, 2005 or by email on July 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a rash, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Switzerland
______________________________________________________________________
PRODUCT
Platelets, Recall # B-0484-08
CODE
Unit: 9821739
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 28, 2005 and by letter on November 9, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
______________________________________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0491-08
CODE
Unit: 22LP26438
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on June 6, 2007 and by letter on June 20, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of whole blood more than eight hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate;
b) Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24;
c) Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw cadies, Recall # Z-0136-2008
CODE
a) Lot Numbers: R330, R342, and R343;
b) and c) All Lots
RECALLING FIRM/MANUFACTURER
OrthoHelix Surgical Designs Inc, Akron, OH, by letter on Sept. 4, 2007. Firm initiated recall is ongoing
REASON
Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
VOLUME OF PRODUCT IN COMMERCE
267 plates
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Recall # Z-0137-2008
CODE
Serial numbers: LTP-90088, LTP-90090, LTP-90092, LTP-90095, LTP-90105, LTP-90106, LTP-90107, LTP-90108, LTP-90109, LTP-90110, LTP-90111, LTP-90112, LTP-90113, LTP-90114, LTP-90115, LTP-90117, LTP-90118, LTP-90119, LTP-90122, LTP-90127, LTP-90130, LTP-90131, LTP-90134, LTP-90135, LTP-90136, LTP-90138, LTP-90139, LTP-90140, LTP-90141, LTP-90142, LTP-90143, LTP-90146, LTP-90147, LTP-90149, LTP-90150, LTP-90151, LTP-90152, TP-30153, TP-30013, TP-30025, TP-30136
RECALLING FIRM/MANUFACTURER
Freedom Designs Inc, Simi Valley, CA, by letter on May 15, 2007. Firm initiated recall is ongoing.
REASON
Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.
VOLUME OF PRODUCT IN COMMERCE
42 chairs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972226, Size 6 X 12, MATL: Steel/Titanium, Rx only,
Recall # Z-0138-2008;
b) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972246, Size 6 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0139-2008;
c) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972266, Size 6 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0140-2008;
d) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972247, Size 7 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0141-2008;
e) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972267, Size 7 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0142-2008;
f) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial,
REF/Catalog #: 6972287, Size 7 X 18, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0143-2008
CODE
a) Lot Numbers: CN07G002, CN07F006, 434150, CN06M009, CN6M016, and 506850;
b) Lot Numbers: CN06M008, CN07A021, 430016, 520351, 515706, 515725, 518405,
520343, 515704, 515705, 523112, 523110, 520340, and 533001;
c) Lot Numbers: CN07A030, CN07A024, 434226, 505039, 515349, 514674, 515343,
520034, 515347, 517759, 520032, 520033, 513711, 515350 and 508115;
d) Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650,
510189, 515311, 513692, 521191, 523113, 421195 and 521188;
e) Lot Numbers: CN07A034, CN07A031, 434185, 508110, 508111, 508108, 515701,
515702, 508112, 515686, 518409, 518410, 522181, 522179 and 522180;
f) Lot Numbers: CN07A010, CN06M007, 434180, 437093, 506906, 506907, 505041,
506885, 506909, 506890, 506893, 513727, 515357, 515355, 523089, 523103, 523102
and 523121
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter and e-mail on September 4, 2007.
Manufacturer: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN. Firm initiated recall is ongoing.
REASON
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
VOLUME OF PRODUCT IN COMMERCE
1,176 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Accuprobe Group B Streptococcus Culture Identification Test, Catalog number: 2820B, Batch number: 531379, Recall # Z-0145-2008
CODE
Lot Number: 531379
RECALLING FIRM/MANUFACTURER
Gen-Probe Inc, San Diego, CA, by telephone on May 2nd and 3rd, 2007 and by letter on May 3, 2007. Firm initiated recall is complete.
REASON
Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
VOLUME OF PRODUCT IN COMMERCE
106 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral
Socket Insert, Catalog #: 508-00-036, Sterile, Recall # Z-0184-2008;
b) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 40 RSP
Humeral Socket Insert, Catalog #: 508-00-040, Sterile, Recall # Z-0185-2008;
CODE
a) Lot #: 602032;
b) Lot #: 601482
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by telephone and letter on August 8, 2007. Firm initiated recall is complete
REASON
Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - DGS P/N 303896;
Solitaire-SGS P/N 3038960, Recall # Z-0286-2008;
b) Ellex Integre Duo, Model No: LP1RG -S P/N 3040000. The Integre Duo is a dual-
wavelength surgical photocagulator laser intended for use in a clinic, outpatient
clinic, or a retinal specialist's office, Recall # Z-0287-2008
CODE
a) Serial # /system #: 31577 /4A2149, 32263 /4A2150, 32256 /4A2152, 32224 /4A2162,
32264 /4A2165, 32627 /4A2174D;
Serial # /system #: 31313 /4A2129, 32223 /4A2148, 32728 /4A2160,
32733 /4A2175S;
b) Serial # /system #: 31418 / ID1057
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ellex USA, Eden Prairie, MN, by telephone on June 13, 2007 and by letters on September 27, 2007.
Manufacturer: Ellex Medical Pty Ltd, Adelaide, SA Australia. Firm initiated recall is ongoing.
REASON
Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
C.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed), Model No: 9VIR1200, Recall # Z-0304-2008
CODE
Serial Numbers: 1001, 1002, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1052, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1096, 1097, 1098, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1155, 1156, 1157, 1158, 1159, 1160, 1161, 1162, 1163, 1164, 1165, 1166, 1168, 1169, 1170, 1171, 1172, 1173, 1174, 1175, 1176, 1177, 1178, 1179, 1180, 1181, 1182, 1183, 1184, 1185, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1193, 1194, 1195, 1196, 1197, 1198, 1199, 1200, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1211, 1212, 1213, 1214, 1215, 1216, 1217, 1218, 1219, 1220, 1221, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1231, 1232, 1233, 1234, 1235, 1236, 1237, 1238, 1239, 1241, 1242, 1243, 1245, 1246, 1247, 1248, 1249, 1250, 1251, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1261, 1262, 1263, 1265, 1266, 1267, 1268, 1270, 1271, 1272, 1273, 1274, 1275, 1276, 1278, 1279, 1280, 1281, 1282, 1283, 1285, 1286, 1287, 1288, 1289, 1290, 1291, 1292, 1294, 1295, 1296, 1297, 1298, 1299, 1300, 1301, 1302, 1303, 1305, 1306, 1307, 1308, 1309, 1310, 1311, 1312, 1313, 1314, 1315, 1316, 1317, 1318, 1319, 1320, 1321, 1322, 1323, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1345, 1346, 1347, 1348, 1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1358, 1359, 1360, 1361, 1362, 1363, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1385, 1386, 1387, 1388, 1389, 1390, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401, 1402, 1403, 1405, 1406, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1445, 1446, 1447, 1448, 1449, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1460, 1461, 1462, 1463, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1485, 1486, 1487, 1489, 1490, 1491, 1492, 1493, 1494, 1495, 1496, 1498, 1499, 1500, 1501, 1502, 1503, 1504, 1505, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1517
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated September 11, 2007.
Manufacturer: Danish Diagnostic Dev. A/S, Hrsholm, Denmark. Firm initiated recall is ongoing.
REASON
Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
VOLUME OF PRODUCT IN COMMERCE
486 units
DISTRIBUTION
Worldwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE – CLASS I ___________________________________
PRODUCT
Hartz Vitamin Care for Cats and Kittens; Vitality Formula: Delivers Critical Daily Nutrients Pets Need for Optimal Health; Liver Flavored; Net contents: 100 chewable Tablets. UPC 32700-97701, Recall # V-020-2008
CODE
Lot: SZ-16371
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hartz Mountain Corp., Secaucus, NJ, by letters on November 5, 2007.
Manufacturer: UFAC (USA), Inc., Baconton, GA. Firm initiated recall is ongoing.
REASON
Surveillance samples collected and analyzed by FDA tested positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,772 bottles (231 cases)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE – CLASS III
___________________________________
PRODUCT
a) Wild Harvest Fruit and Honey Cockatiel, Recall # V-021-2008;
b) Ecotrition Tropical Fruit and Honey Bars, Recall # V-022-2008;
c) Wild Harvest Hamster, Gerbil, Mouse & Rat Honey Cakes, Recall # V-023-2008
CODE
a) Lot: 07096 and Lot: 07108;
b) and c) Lot: 07096
RECALLING FIRM/MANUFACTURER
United Pet Group Inc., Cincinnati, OH, by telephone and letter. Firm initiated recall is ongoing.
REASON
Pet treats were imported from China. LOS-DO sampled the treats and they were positive for melamine. The shipments were placed on hold for redelivery and was erroneously shipped into commerce.
VOLUME OF PRODUCT IN COMMERCE
54,178 units
DISTRIBUTION
AZ, CA, FL, MI, NJ, NY, TX, and WA

END OF ENFORCEMENT REPORT FOR DECEMBER 26, 2007

###

RSS Feed for FDA Enforcement Report [what is RSS?]

rule