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U.S. Department of Health and Human Services

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Enforcement Report for May 31, 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.

May 31, 2006
06-22

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

______________________________
PRODUCT
ARNOLD brand Country Classics OAT BRAN Bread, Net Wt. 1 LB 8 OZ (680g) --- The
bread is packaged in a flexible plastic bag. UPC barcode # 0 73410 01354 0, Recall # F-174-6
CODE
Date codes January 8 or January 9 preceded by the number “360"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arnold Foods Company, Inc, Horsham, PA, by press release, fax and e-mail on January 4, 2006, and January 5, 2006.
Manufacturer: Name George Weston Bakeries, Inc., Gastonia, North Carolina, firm initiated recall is complete.
REASON
Oat bran bread contains undeclared walnuts and hazelnuts.
VOLUME OF PRODUCT IN COMMERCE
2,736 units
DISTRIBUTION
AL, GA, TN, NC and SC

______________________________
PRODUCT
Sam's Choice brand of Belgian Milk Chocolate, 7 oz. (200 gm). Product of Belgium, UPC Code #78742 09803. Product packaged with foil inner wrap and purple, paper outer wrap, Recall # F-175-6.
CODE
''BEST BY: D2551A2 DEC 20 2006''
RECALLING FIRM/MANUFACTURER
Recalling Firm: Brachs Confections Incorporated, Dallas, TX, by press release, telephone and e-mail on March 21, 2006.
Manufacturer: Chocolaterie Jacques S.A., Eupen, Belgium. Firm initiated recall is ongoing.
REASON
Chocolate bars contains undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
1,447 cases (13 bars per case)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Green Onions *** 4 DOZEN BUNCHES *** New Millennium FARMS, INC. California GREEN ONIONS *** PRODUCE OF MEXICO NEW MILLENNIUM FARMS, INC. SHIPPING IN SEASON FROM CALIFORNIA AND ARIZONA, Recall # F-176-6
CODE
Lot Code 01109063
RECALLING FIRM/MANUFACTURER
Recalling Firm: Circle Produce Co Inc., Calexico, CA, by telephone on March 15, 2006 and by letter on March 16, 2006.
Manufacturer: Cia Agricola Omega S De R L De C V, Mexicali, Mexico, firm initiated recall is ongoing.
REASON
FDA analysis found the product contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
80 Cartons (5kg/Carton, 12 packages/Carton)
DISTRIBUTION
CA

______________________________
PRODUCT
Kroger Frozen Pizza Bites, Sauce & Mozzarella Cheese Wrapped in Dough, Net Wt. 20 oz. UPC 11110-82334, Recall # F-177-6
CODE
Sell by Dates: FEB 17/07, MAR 3/07, MAR 6/07, MAR 8/07, MAR 14/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frozen Specialties Inc., Archbold, OH, by e-mail and telephone on March 15, 2006 and by press release on March 17, 2006.
Manufacturer: FSI/MFP, Inc. dba Matlaw's Food Products, West Haven, CT, firm initiated recall is complete.
REASON
Products contain undeclared soy flour.
VOLUME OF PRODUCT IN COMMERCE
2004 cases X 9 bags
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Best Brands Twisted Snails Frozen Danish Dough, product code 1500-03. 72 - 2.5 oz. Net Weight: 11.25 lbs. UPC # 10035074150037. Recall # F-178-6
CODE
All cases identified with a “Best Used By" date prior to May 16, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Brands Corp., Minnetonka, by fax, e-mail and letter on February 20, 2006.
Manufacturer: Top Taste, Inc., Finley, ND, firm initiated recall is ongoing.
REASON
The product contains soy flour that was not listed on the ingredient label. The frozen Danish Twist dough was sold to retail and grocery store bakeries and other foodservice outlets. Consumers may have purchased the product as baked, spiral-shaped Danish, either iced, filled or plain.
VOLUME OF PRODUCT IN COMMERCE
9480 Cases (72 pieces per case)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Worthington brand Vegetable Skallops Made with Vegetable & Grain Protein packed in Net Wt 1lb. 4 oz. cans, UPC Code 28989 23303, Recall # F-179-6
CODE
Code on can bottom includes the following: 10055 CS SK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Company, Battle Creek, MI, by letters dated April 6, 2006.
Manufacturer: Castleberry's Food Company, Augusta, GA, firm initiated recall is ongoing.
REASON
The cans may contain a different product called Super-Links, resulting in the presence of the undeclared egg and milk allergens.
VOLUME OF PRODUCT IN COMMERCE
9,456 cans
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Peanut butter egg, packaged in 6 ounce and 12 ounce size packages. Product is
packaged in a cardboard box with a clear cellophane front. Product is identified as
Anthony Thomas Chocolates, Columbus, OH. Recall # F-181-6;
b) Butter cream egg, packaged in 6 ounce and 12 ounce size packages. Product is
packaged in a cardboard box with a clear cellophane front. Product is identified as
Anthony Thomas Chocolates, Columbus, OH. Recall # F-182-6;
c) Chocolate Fudge Pecan egg, packaged in 6 ounce and 12 ounce size packages.
Product is packaged in a cardboard box with a clear cellophane front. Product is
identified as Anthony Thomas Chocolates, Columbus, OH. Recall # F-183-6;
d) Chocolate Plain Fudge Decorated egg, packaged in 6 ounce and 12 ounce size
packages. Product is packaged in a cardboard box with a clear cellophane front.
Product is identified as Anthony Thomas Chocolates, Columbus, OH. Recall # F-184-
6;
e) Maple Walnut Fudge Decorated egg, packaged in 6 ounce and 12 ounce size
packages. Product is packaged in a carboard box with a clear cellophane front.
Product is identified as Anthony Thomas Chocolates, Columbus, OH.
Recall # F-185-6;
f) Solid Milk Chocolate with Pecans Easter egg, packaged in 6 ounce and 12 ounce size
packages. Product is packaged in a carboard box with a clear cellophane front.
Product is identified as Anthony Thomas Chocolates, Columbus, OH.
Recall # F-186-6;
g) Solid Milk Chocolate plain Easter egg, packaged in 6 ounce and 12 ounce size
packages. Product is packaged in a cardboard box with a clear cellophane front.
Product is identified as Anthony Thomas Chocolates, Columbus, OH.
Recall # F-187-6
CODE
Lot Codes: 6027-6083
RECALLING FIRM/MANUFACTURER
Anthony Thomas Candy Company Inc., Columbus, OH, by press release on March 28, 2006, by telephone March 27, 2006 and by letter on March 30, 2006, firm initiated recall is ongoing.
REASON
The product contains undeclared egg whites in the “sugar star" decoration on the candy. The “sugar star" decoration also contained undeclared colors including FD&C yellow No. 5 and FD&C yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
15,708 pieces (individual easter eggs)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
HOME STYLE SALAD SELECTION GOLDEN Taste brand NOVA LOX SALAD, Net Wt. 3.5 oz., 7.5 oz., and 5 lbs. --- Ing: Naturally Smoked Salmon, Mayonnaise (Eggs, Oil, Water, Vinegar, Sugar, Salt), Spices, Potassium Sorbate & Sodium Benzoate. The product is packaged in a rigid plastic container, UPC barcode # 7 58259 77157 7 (7.5 oz, Recall # F-190-6
CODE
Date code 8/18/05
RECALLING FIRM/MANUFACTURER
Golden Taste, Inc., City Spring Valley, NY, by press release on July 15, 2005, firm initiated recall is complete.
REASON
The product was found to be contaminated with Listeria monocytogenes based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY and NJ

______________________________
PRODUCT
(Woodsmoke label) Woodsmoke Provisions™ * Premium Smoked Salmon, Net Weight 4oz * Sliced and Ready to Eat * Pastrami Style * * Smoked Salmon must be refrigerated at 38F or below. Once opened it will keep for 4-5 days when kept tightly wrapped and properly refrigerated. If unopened, this product may be frozen without harm for up to three months. (Fresh Market label adhered to the back of the package) Pastrami Smoked Salmon 4 oz. * Packed on Oct-31-05 *, Recall # F-191-6
CODE
Woodsmoke lot code: 301-05 855
RECALLING FIRM/MANUFACTURER
Woodsmoke Provisions Company, Atlanta, GA, by visit on December 1, 2005 and by press release on December 15, 2005, firm initiated recall is ongoing.
REASON
The product was found to be contaminated with Listeria monocytogenes based on analysis by the Florida Department of Agriculture and Consumer Services.
VOLUME OF PRODUCT IN COMMERCE
112 packages
DISTRIBUTION
FL

______________________________
PRODUCT
Individual sandwich labeling: egg salad on Vienna bread, net wt. 4.50 oz., Pilot good to go. Case labeling: Pilot 0317, 12 Individually Wrapped Sandwiches, Recall # F-193-6
CODE
Lot code: “5355"
RECALLING FIRM/MANUFACTURER
Classic Delight, Inc., St Marys, OH, by telephone on March 3, 2006, firm initiated recall is ongoing.
REASON
The product was found to be contaminated with Listeria monocytogenes based on analysis by the Ohio Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
410 cases/12/4.50 oz sandwiches per case
DISTRIBUTION
OH

______________________________
PRODUCT
Deli fresh BBQ Beans, packaged in 16 oz, 48 oz, and 80 oz plastic tub; also packaged as Hill Country Fare Deli Style Cowboy Ready to Enjoy BBQ Beans, 16 oz size only, Recall # F-198-6
CODE
Product code 04071, 16 oz container, deli fresh BBQ beans, Use by: 9/28/05 and Use by: 9/29/05; Product code 04076, 16 oz container, Hill Country Fare Cowboy Beans, Use by: 9/25/05; Product code 04073, 48 oz container, deli fresh BBQ beans, Use by: 9/28/05; and Product code 04751, 80 oz container, Allison's BBQ Beans, Use by: 9/28/05
RECALLING FIRM/MANUFACTURER
Allison's Gourmet Kitchen, Moore, OK, by press release and telephone on August 24, 2005 and by letters on August 25, 2005, firm initiated recall is ongoing.
REASON
Product was contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
302 cases
DISTRIBUTION
IL, TX and OK

______________________________
PRODUCT
BROWNBERRY NATURAL WHEAT BREAD, 1 Lb 8 Oz (680g). The bread is packed in a flexible plastic package with white or blue square lock tab closure. UPC # 73410 01722, Recall # F-199-6
CODE
Feb 27 (found on white or blue square lock tab closure)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arnold Foods Company, Horsham, PA, by press release on February 23, 2006.
Manufacturer: George Weston Bakeries, Inc., Riviera Beach, FL, firm initiated recall is complete.
REASON
Firm received 2 complaints from consumers who found walnuts in the product. Walnuts were not declared on the product labeling.
VOLUME OF PRODUCT IN COMMERCE
2460 units
DISTRIBUTION
AL, FL, GA, NC, SC, and TN

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

______________________________
PRODUCT
a) Fruit and Nut Easter egg, packaged in 6 ounce and 12 ounce size packages. Product
is packaged in a cardboard box with a clear cellophane front, Recall # F-188-6
b) Coconut Easter egg, packaged in 6 ounce and 12 ounce size packages. Product is
packaged in a cardboard box with a clear cellophane front, Recall # F-189-6
CODE
Lot Codes: 6027-6083
RECALLING FIRM/MANUFACTURER
Anthony Thomas Candy Company Inc., Columbus, OH, by press release on March 28, 2006, by telephone March 27, 2006 and by letter on March 30, 2006, firm initiated recall is ongoing.
REASON
The product contains undeclared colors including FD&C yellow #5 and FD&C yellow #6 which are not identified on the product label.
VOLUME OF PRODUCT IN COMMERCE
15,708 pieces (individual Easter eggs)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Federico's Gourmet Italian Bakery brand Italian Deluxe Assortment, 14 oz, Item No.
118, packaged in clear plastic packages, Recall # F-194-6;
b) Federic's Gourmet Italian Bakery brand Fancy Butter Cookie Assortment, 11.50 oz,
Item No. VS119, packaged in clear plastic packages, Recall # F-195-6;
c) Federico's Gourmet Italian Bakery brand Fancy Butter Cookie, 32 oz, Item No. V119,
packaged in clear plastic packages, Recall # F-196-6;
d) Federico's Gourmet Italian Bakery brand Butter Cookie Apricot Center , 11.50 oz,
Item No. VS122, packaged in clear plastic packages, Recall # F-197-6
CODE
The products are not encoded with a manufacturing date.
RECALLING FIRM/MANUFACTURER
Federico's Bakery, Duarte, CA, by press release on February 27, 2006 and by telephone and letter on February 28, 2006. Firm initiated recall is ongoing.
REASON
a), b), c), The product contains undeclared FD&C colors: Yellow No. 5, Yellow No. 6,
Red No. 40 and Blue No 1;
d) The product contains undeclared FD&C colors: Yellow No. 5, Yellow No. 6
VOLUME OF PRODUCT IN COMMERCE
1,176 packages (13.5 oz each)
DISTRIBUTION
CA

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

______________________________
PRODUCT
EAS, AdvantEdge Carb Control Ready-to-Drink (RTD) Shake, 11 oz serving, French Vanilla Flavor Product, Item #58641, UPC #7-91083-30233-3. The product has three (3) separate packages (Primary, secondary, and tertiary). The Tetra container, or primary package, contains the actual nutritional shake. Four (4) Tetra containers are then overwrapped with a secondary package (4-pack). The secondary packaging is contained inside a corrogated cardboard case which contains six (6) 4-pack packages, Recall # F192-6
CODE
Lot #39576 DQ00, Best Before: 1 Oct 2007
RECALLING FIRM/MANUFACTURER
Ross Products Division, Abbott Laboratories, Columbus, OH by telephone on 4/14/2006 and by letter on 4/20/2006.
Manufacturer: Jasper Products, Llc, Joplin, MO, firm initiated recall is ongoing.
REASON
Packages containing 4 individual bags of French Vanilla Flavored Shake are mislabeled as containing Strawberry Flavored shake.
VOLUME OF PRODUCT IN COMMERCE
547 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Verelan® PM extended-release capsules (verapamil hydrochloride), 300 mg, 100 capsules per bottle, Rx only, NDC 0091-4087-01, Recall # D-252-6
CODE
Lots: 5K066 (exp. 7/07), 5K124 (exp. 8/07)
RECALLING FIRM/MANUFACTURER
Elan Holdings, Inc., Gainesville, GA, by telephone on March 23, 2006, and by letters on April 19, 2006 and May 22, 2006. Firm initiated recall is ongoing.
REASON
Low fill weight capsules.
VOLUME OF PRODUCT IN COMMERCE
10,269/100-capsule bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Pulmicort Respules 0.25 mg/2mL (budesonide inhalation suspension) Rx only, NDC 0186-1988-04, Recall # D-255-6
CODE
Lot Number: MA0133 Exp. Date: JAN 08
RECALLING FIRM/MANUFACTURER
AstraZeneca LP, Westborough, MA, by letter on May 16, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
384 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Greenstone brand cabergoline tablets, 0.5 mg, 8 tablets per bottle, RX only, NDC 59762-0100-1, Recall # D-247-6
CODE
Lot B922A (exp. 3/07), NDC 59762-0100-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greenstone Ltd., Peapack, NJ, by recall notification packages on April 27, 2006.
Manufacturer: Pfizer Italia S.r.l. Marino del Tronto, Italy. Firm initiated recall is ongoing.
REASON
Product will not meet established potency and impurity specifications throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
54,270/8 tablet bottles
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Dostinex tablets (cabergoline), 0.5 mg, 8 tablets per bottle, Rx only, NDC 0013-7001-12, Recall # D-248-6
CODE
Lots: A526A (exp. 2/07), A528A (exp. 2/07), B086A (exp. 5/07), B599Y (exp. 1/07), B921Z (exp. 3/07), 4HXG7B (exp. 10/06), 4HXGAK (exp. 11/06), 4HXG6E (exp. 10/06), 4HXG6F (exp. 10/06); NDC 0013-7001-12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., NY, NY, by letters on April 27, 2006.
Manufacturer: Pfizer Italia S.r.l., Marino, Italy. Firm initiated recall is ongoing.
REASON
Product will not meet established potency and impurity specifications throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
404,969/8-tablet bottles
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
PREMPRO™ (conjugated estrogen/medroxyprogesterone acetate tablets) 0.45
mg/1.5 mg, Rx only, NDC 0046-0937-08. Recall # D-253-6;
b) PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3
mg/1.5 mg, Rx only, NDC 0046-0938-08. Recall # D-254-6
CODE
a) Lot A66957 (exp. 8/06);
b) Lot B13132 (exp. 2/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters dated May 8, 2006.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY, firm initiated recall is ongoing.
REASON
FAILED USP DISSOLUTION TEST REQUIREMENT.
VOLUME OF PRODUCT IN COMMERCE
Prempro 0.45 mg/1.5 mg: 25,186 cartons of 3 dispensers;
Prempro 0.3 mg/1.5 mg: 23,254 cartons of 3 dispensers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1036-6;
b) Red Blood Cells, Recall # B-1037-6
CODE
a) Units: 6523167, 6524643, 6522293, 6358967, 6524762, 6526262,
6526278, 6522345, 6524779, 6527476, 6358984, 6515098, 6525534, 6525918,
6358985, 6525757, 6527393, 6527396, 6527503, 6527504, 6527520, 6525974,
6527528, 6527553, 6527672, 6527576, 6524015, 6526589, 6526875, 6527746,
6528201, 6528494, 6528835, 6526786, 6528531, 6528926, 6528947, 6520583,
6528755, 6528763, 6520021, 6525339, 6528366, 6529406, 6530059, 6531570,
6515124, 6524076, 6524087, 6528387, 6529652, 9524094, 6524095, 6525373,
6530142, 6532777, 6529703, 6521690, 6522350, 6525687, 6358977, 6527734,
6527737, 6528251, 6527864, 6524056, 6528067, 6528089, 6527509;
b) Units: 6526491, 6471993, 6527586, 6515109, 6527884, 6528290, 6526559
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Lakeland, FL, by letter dated July 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not have the monthly quality control testing for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells (Pheresis) Leukocytes Reduced, Recall # B-1084-6
CODE
Units: 10048-8788 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on March 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1103-6;
b) Fresh Frozen Plasma, Recall # B-1104-6;
c) Recovered Plasma, Recall # B-1105-6
CODE
a) Unit numbers: 12GY31921, 12E07907;
b) Unit number: 12E07907;
c) Unit number: 12GY31921
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated April 19, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1106-6;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1107-6
CODE
a) Unit numbers: 7106574 (parts 1 & 2), 7106575, 7106577, 7106578 (parts 1 & 2),
7106580, 7106582, 7109957, 7109958, 9109959, 7109960, 7109961, 7109962,
7109963, 7110111, 7110112, 7110113, 7110114, 7110115, 7110116, 7110117,
7110118, 5579250, 5579253;
b) Unit number: 7106576, 7110119, 5579252
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone, facsimile, or electronic notification beginning December 6, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm cleansing procedures were performed using expired cleansers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
LA, MI, NJ, and OH

______________________________
PRODUCT
Platelets, Recall # B-1110-6
CODE
Unit number: 8211263
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, Colorado, by telephone on December 22, 1998. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had tested initially reactive for HIV-1 p24 antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Recall # B-1121-6
CODE
Unit number: 404637
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on December 18, 1998. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Source Plasma, Recall # B-1133-6
CODE
Unit number: 0050254171
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., Beloit, WI, by fax on January 23, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously been incarcerated, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK

______________________________
PRODUCT
Source Plasma, Recall # B-1134-6
CODE
Unit numbers: 05CILB6476, 05CILB5804
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Chicago, Chicago, IL, by facsimile on January 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of an accidental needle stick, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1135-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1136-6;
c) Platelets, Recall # B-1137-6;
d) Fresh Frozen Plasma, Recall # B-1138-6
CODE
a) Unit number: 7872911;
b) Unit numbers: 3179034, 3180261;
c) Unit number: 3180261;
d) Unit numbers: 3179034, 3180261
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on January 30, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Recall # B-1142-6
CODE
Unit number: 2485963
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on March 14, 2006. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Recall # B-1143-6
CODE
Unit number: FH44627
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Aurora, IL, by letter dated February 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1144-6
CODE
Unit number: 40LX07434
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region, Peoria, IL, by telephone on February 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub was incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Human Corneas, Recall # B-1146-6
CODE
Tissues: CI0472470S, CI047247OD
RECALLING FIRM/MANUFACTURER
Illinois Eye Bank, Chicago, IL, by telephone on March 6, 2006 and by letter dated March 10, 2006. Firm initiated recall is complete.
REASON
Human tissue for transplantation, which was incorrectly tested for viral markers in that the blood sample used for testing was hemodiluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
MI

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1169-6;
b) Recovered Plasma, Recall # B-1170-6
CODE
a) and b) Unit numbers 039J46789 and 039J49308
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by facsimile on September 14, 2005 and by letter on September 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, KY, WV and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1171-6;
b) Recovered Plasma, Recall # B-1172-6
CODE
a) and b) Unit number: KC19172
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on May 26, 2004. 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
WI and Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-1173-6
CODE
Unit numbers: OF190501, OF190300, OF189668, OF188962, OF188778, OF188363, OF187970, OF187667, OF186348, OF186146, OF185792, OF185566, OF185136, OF184920, OF183886, OF183563, OF183355, OF182851, OF182439, OF182239, OF181820, OF181613, OF181220, OF181013, OF180191, OF179887, OF179623, OF179159, OF178778, OF178618, and OF177012
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Orlando, FL, by facsimile on June 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Recall # B-1174-6
CODE
Unit number: 6964126
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1201-6
CODE
Unit number: 581351
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on January 24, 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
LA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1203-6
CODE
Unit number: 3782799
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on August 16, 2004. 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
LA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1204-6
CODE
Unit numbers: 3780994 and 3780907
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on July 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1205-6
CODE
Unit number: 3782972
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on September 23, 2004. 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
LA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1206-6;
b) Platelets, Recall # B-1207-6
CODE
a) and b) Unit number: 7113736
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone and letter on November 23, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA and MI

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1092-6;
b) Recovered Plasma, Recall # B-1093-6
CODE
a) Unit numbers: 12LS86037, 12LS86038, 12LS86039, 12LS86040, 12LS86041,
12LS86043, 12LS86044, 12LS86045, and 12LS86046;
b) Unit numbers: 12LS86037, 12LS86038, 12LS86039, 12LS86040, 12LS86041,
12LS86043, 12LS86044, 12LS86045, and 12LS86046
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone or electronically on June 18, 2004 and by letter on June 29, 2004. Firm initiated recall is complete.
REASON
Blood products, for which shipping conditions were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
NC, TN, and Switzerland

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1094-6
CODE
Unit numbers: 9043583 and 9043587
RECALLING FIRM/MANUFACTURER
Blood Connection, Inc., Greenville, SC, by telephone on March 21, 2005. Firm initiated recall is complete.
REASON
Blood products, which were shipped at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and MD

______________________________
PRODUCT
Platelets, Recall # B-1120-6
CODE
Unit numbers: 415388, 415374
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, Colorado, by telephone on February 22, 1999. Firm initiated recall is complete.
REASON
Blood products, improperly stored after production, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Recall # B-1129-6
CODE
Unit number: 0495082
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on July 11, 1999. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Recovered Plasma (for manufacture of non-injectables), Recall # B-1139-6
CODE
Unit number: 7872911
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by facsimile on January 31, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall# B-1141-6
CODE
Unit numbers: 4615668 (split unit)
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on January 9, 2006. Firm initiated recall is complete.
REASON
Platelets, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall# B-1145-6
CODE
Unit number: 40GR79624
RECALLING FIRM/MANUFACTURER
American National Red Cross, Peoria, IL, by telephone on February 7, 2006. Firm initiated recall is complete.
REASON
Blood products, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1202-6
CODE
Unit number: 3773128
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated January 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured using an expired leukocyte-reduction filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5**, Recall # Z-0873-06
CODE
Lot Codes: 05.13.05.01; 05.24.05.16; 06.09.05.24; 06.15.05.13; 07.06.05.08; 07.13.05.05.03; 07.14.05.06; 07.19.05.10; 07.28.05.15; 08.03.05.15; 08.10.05.15; 08.17.05.18; 08.17.05.30; 08.17.05.31; 09.07.05.23; 09.21.05.16; 09.28.05.16; 10.05.05.29; 10.19.05.22; 12.28.05.06; 01.11.06.16; 02.01.06.15; 02.01.06.16; 02.15.06.23; 02.15.06.24
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinetic Concepts, Inc, San Antonio, TX, by letters on March 17, 2006.
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico, firm initiated recall is ongoing.
REASON
Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
VOLUME OF PRODUCT IN COMMERCE
6,453 cases (5 dressings per case)
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic,
Recall # Z-0874-06;
b) Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic,
Recall # Z-0875-06;
c) Stratus CS STAT Fluorometric Analyzer Acute Care c TnI TestPak (CCTNI) in vitro
diagnostic, Recall # Z-0876-06;
d) Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic,
Recall # Z-0877-06;
e) Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic,
Recall # Z-0878-06;
f) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro
diagnostic, Recall # Z-0879-06;
g) Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic,
Recall # Z-0880-06;
h) Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic,
Recall # Z-0881-06;
i) Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic,
Recall # Z-0882-06;
j) Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic,
Recall # Z-0883-06;
k) Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic,
Recall # Z-0884-06;
l) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro
diagnostic, Recall # Z-0885-06
CODE
a) Lot #446003002 and 446058002;
b) Lot #245276002; 245289002; 245304002; 245318002; 245332002; 245361002;
246023002; 246037002; 246051002; 246065002; and 246079002;
c) Lot # 235276002; 235283002; 235290002; 235297002; 235304002; 235311002,
235318002; 235325002; 235338002; 235339002; 235346002; 235353002;
235361002; 236009002; 236016002; 236023002; 236030002; 236037002;
236044002; 236051002; 236058002; 236065002; 236072002; and 236079002;
d) Lot # 405297002; 405346002; 405030002; 406003002; and 406079002;
e) Lot # 515283002; 515311002; 515332002; 515339002; 516003002; 516016002;
516044002; 516058002; and 516072002;
f) Lot # 215276002; 215311002; 215332002; 216030002; 216065002;
g) Lot # 945297002; 945332002; 946011002; 946044002;
h) Lot # 845304002 and 846058002;
i) Lot # 835332002 and 836044002;
j) Lot # 805283002; 805346002; 806044002;
k) Lot # 816023002;
l) Lot # 916065002
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc, Newark, DE, by letters on April 6, 2006, firm initiated recall is ongoing.
REASON
Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
VOLUME OF PRODUCT IN COMMERCE
20,927 cartons
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Software version 1.0 or 1.0.1, Recall # Z-0889-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by firm representative visit, beginning June 2004, firm initiated recall is ongoing.
REASON
Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
VOLUME OF PRODUCT IN COMMERCE
397 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Life Pulse High Frequency Ventilator (HFV), Recall # Z-0893-06
CODE
Serial numbers 2585 and below
RECALLING FIRM/MANUFACTURER
Bunnell, Inc, Salt Lake City, UT, by letter on April 4, 2005, firm initiated recall is ongoing.
REASON
Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
VOLUME OF PRODUCT IN COMMERCE
297 units
DISTRIBUTION
Nationwide, Canada, and Czech Republic

______________________________
PRODUCT
Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Recall # Z-0895-06
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Target, Fremont, CA, by letters on April 25, 2006.
Manufacturer: Boston Scientific, West Valley City, UT, firm initiated recall is ongoing.
REASON
During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
VOLUME OF PRODUCT IN COMMERCE
444 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and
Innova 200S mobile version. Cardiovascular Imaging System, Recall # Z-0896-06;
b) GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an
option, Cardiovascular Imaging System, Recall # Z-0897-06;
c) GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an
option. Digital Fluoroscopic Imaging System, Recall # Z-0898-06
CODE
All serial numbers, all devices manufactured before November 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by a validated field action on March 6, 2006.
Manufacturer: General Electric Medical Systems, SCS, Bue Cedex, France, firm initiated recall is ongoing.
REASON
Incorrect screws were used for mounting the detector, which may lead to a possible part falling onto a patient.
VOLUME OF PRODUCT IN COMMERCE
1,447 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic, Recall # Z-0899-06
CODE
Lot 672652; exp. 6/30/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN, by letter dated April 12, 2006.
Manufacturer: Roche Diagnostics GmbH, d-68305 Mannheim, Germany. Firm initiated recall is ongoing.
REASON
A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
VOLUME OF PRODUCT IN COMMERCE
269 kits
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1, Recall # Z-0904-06
CODE
Devices manufactured between July 1, 2001 and December 31, 2004.
Serial Number (S/N) Range: C-CB-L2 (S/N's 0301L0905;
S/N's: 0110L001 to 0412L0176, 0110J194 to 0204J0795, 0205H0043 to 412H0080;
S/N's 0206L1296 to 0409L2483, 0206H0945 to 0409H2570;
S/N's 0107L0030 to 0412L0524, 0110J0195 to 0201J1338, 0202H0586 to 412H0082;
S/N's 0110L061 to 0412L0127, 0110J098 to 0208J0162, 0112H555 to 0409H2418
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunrise Medical CCG, Inc. Stevens Point, WI, by letters in January 2006 and April 26, 2006.
Manufacturer: Apex Health Care Manufacturer, Inc, Chia Yi Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.
VOLUME OF PRODUCT IN COMMERCE
32,109 devices
DISTRIBUTION
Nationwide, Canada, Asia, South America

______________________________
PRODUCT
Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml, Recall # Z-0906-06
CODE
FPB NEP, batch # X-003, code 722842
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grifols Biologicals Inc. Los Angeles, CA, by telephone beginning November 11, 2005.
Manufacturer: Laboratorios Grifols, S.A.-Spain, Barcelona, Spain. Firm initiated recall is ongoing.
REASON
When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
VOLUME OF PRODUCT IN COMMERCE
218 units, each unit contains 5 bags
DISTRIBUTION
CA, GA, and OR

______________________________
PRODUCT
Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7" to a high position of 30", Recall # Z-0908-06
CODE
156 Wheelchairs of Kansas and SIZEWise serial numbers. The serial numbers will be listed in the following format: SIZEWise number/Wheelchairs of Kansas number 22639/212666; 23243/212849; 22493/212646; 23245/212851; 21244/212428; 21254/212438; 22132/212502; 22140/212510; 22141/212511; 22142/212512; 22139/212509; 24403/213406; 22640/212667; 21251/212435; 23227/212860; 23228/212868; 23229/212869; 23257/212878/ 24384/213086; 24385/213087; 24398/213282; 24409/213412; 21252/212436; 22128/212498; 22636/212644; 23256/212879; 22502/212655; 22630/212658; 22642/212669; 21245/212429; 22129/212499; 23262/213073; 24401/213285; 22126/212496; 22496/212649; 23232/212863; 23239/212858; 23240/212846; 24402/213286; 23226/212871; 22135/212505; 22137/212507; 23246/212852; 23247/212853; 23248/212854; 23241/212847; 23260/213071; 23274/213084; 24387/213089; 23271/213081; 24396/213080; 22635/212663; 24411/213414; 24413/213416; 24414/213417; 24415/213418; 24416/213419; 24417/213420; 24418/213421; 24419/213425; 24420/213426; 24421/213427; 24422/213428; 25360/213429; 25361/213430; 25362/213431; 25363/213432; 25364/213433; 25365/213434; 25366/213435; 25367/213436; 25368/213437; 22136/212506; 22492/212631; 22638/212665; 22643/212670; 21240/212423; 21241/212424; 21246/212430; 22631/212659; 22632/212660; 22644/212874; 22646/212872; 23261/213072; 23263/213074; 23264/213075; 23265/212875; 23267/213077; 24391/213275; 24397/213281; 24399/213283; 21242/212425; 22498/212651; 23266/213076; 24400/213284; 24407/213410; 24408/213411; 21247/212431; 22495/212648; 23231/212866; 23234/212865; 24390/213123; 24389/213122; 24388/213121; 21253/212437; 23242/212848; 22134/212504; 22138/212508; 23249/212855; 23250/212856; 23251/212857; 23258/212877; 23259/212876; 22499/212652; 22500/212653; 22501/212654; 22628/212656; 22629/212657; 23233/212864; 23236/212861; 23237/212860; 24394/213278; 24395/213279; 21240/212423; 22497/212650; 24393/213277; 24405/213408; 24406/213409; 22127/212497; 22494/212647; 23230/212867; 23238/212859; 23255/212880; 24392/213276; 21249/212433; 21255/212439; 22131/212501; 22637/212671; 23252/212969; 23254/213070; 23270/213080; 24383/213085; 24386/213088; 23235/212862; 23244/212850; 22133/212503; 23253/212970; 23269/213079; 22130/212500; 22634/212662; 22645/212873; 24404/213407; 24410/213413; 22633/212661; 23272/213082; 23273/213083
RECALLING FIRM/MANUFACTURER
Rayes, Inc, dba Wheelchairs of Kansas, Ellis, KS, by visit on/about November 14, 2005 and by service bulletin dated February 28, 2006. Firm initiated recall is ongoing.
REASON
The bed may drop due to a malfunction of the actuator exceeding its stop.
VOLUME OF PRODUCT IN COMMERCE
161 beds
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Powder Free Latex, Non-sterile Medical Exam Gloves, Catalog #'4 22401, 22402, 22403, and 22404, Recall # Z-0909-06
CODE
Lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gulf South Medical Supply Inc, Jacksonville, FL, by letter dated April 10, 2006.
Manufacturer: TG Medical Sdn Bhd, Selangor, Malaysia. Firm initiated recall is ongoing.
REASON
FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.
VOLUME OF PRODUCT IN COMMERCE
815 cases, 100 each per box, 10 boxes per case
DISTRIBUTION
Nationwide

 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-0890-06;
b) CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-0891-06;
c) VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable
cardiac defibrillator), Recall # Z-0892-06
CODE
a) Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666,
360714, 360719, 360721, 360738, 360741, 360742, 360743, 360745, 360746,
360749, 360756, 360758, 360763, 360766, 360790, 360791, 360792, 360796,
360800, 360802, 360844, 360847, 360848, 360861, 360863, 360904, 360907,
360908, 360910, 360986, 360987, 360988, 360989, 360991.
Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537,
310544, 310545, 310706, 310707, 310709, 310713, 310719, 310721, 310734,
310735, 310737, 310746, 310753, 310796, 310798, 310813, 310907, 310908,
310909, 310913, 310916, 310976, 310990, 310996, 311007, 311010, 311011,
311013, 311015, 311016, 311092, 311096, 311152, 311154, 311181, 311185,
311386, 311389.
Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021,
281022, 281024, 281045, 281056, 281066, 28107, 281077, 281119, 281121,
281123, 281124, 281126, 281127, 281143, 281175, 281213, 281233, 281247,
281320, 281356, 281364, 281368, 281371, 281376, 281385, 281401, 281403,
281413, 281476, 281480, 281484, 281485, 281491, 281533, 281539, 281542,
281544, 281559, 281562, 281580.
Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954,
110955, 110958, 110980, 110983, 110987, 110988, 111000, 111001, 111003,
111004, 111007, 111012, 111024, 111041, 111042, 111128, 111173, 111180,
111198, 111201, 111248, 111250, 111254, 111263, 111294, 111299, 111308,
111313, 111334, 111335, 111336, 111338, 111340, 111341, 111342, 111346,
111350, 111352, 111390, 111391, 111392, 111393, 111397, 111422;
b) Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319,
310320, 310321, 310322, 310343, 310353, 310355, 310381, 310383, 310386,
310387, 310388, 310389, 310390.
Model H195, serial numbers: 350236, 350239, 350245, 350247, 350248, 350250,
350252, 350255, 350261, 350264, 350276, 350279, 350280, 350282, 350284,
350319, 350330, 350331, 350332, 350333, 350334, 350336, 350342, 350344,
350350, 350351, 350353, 350354, 350355, 350360, 350362, 350363, 350364,
350365, 350403, 350407, 350442, 350451, 350480, 350484, 350503, 350570,
350649.
Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415,
320417, 320445;
c) Model T125, serial numbers: 115233, 115234, 115237, 115239, 115240, 115241,
115335, 115370, 115399, 115400, 115479.
Model T165, serial numbers: 110803, 110806, 110830, 110833, 110835, 110836,
111081, 111270, 111271, 111273, 111274, 111299, 111329, 111332, 111333,
111337, 111339, 111442, 111493, 111611, 111687, 111842, 111844, 111886,
111979, 112029, 112174, 112175.
Model T175, serial number 109787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by Physician letter, dated October 25, 2005 and by an advisory update, dated December 20, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
VOLUME OF PRODUCT IN COMMERCE
290 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software
Version 4.5; Part Number: A23724 In vitro diagnostic, Recall # Z-0900-06;
b) SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part
Number: A23724, Recall # Z-0901-06;
c) Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0
and 1.2; Part Number: A20463 and A27331, Recall # Z-0902-06
CODE
a) Operating Software Version 4.5;
b) Software Version 4.5;
c) Software Version 1.0 and 1.2
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Fullerton, CA, by letter the week of March 15, 2006.
Manufacturer: Beckman Coulter, Inc., Brea, CA. Firm initiated recall is ongoing.
REASON
It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software version 4.5. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.
VOLUME OF PRODUCT IN COMMERCE
2,800 systems total
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy, Recall # Z-0905-06
CODE
NJH701951H thru NJH801963H, NJH701965H, NJH701967H thru NJH701969H, NJH701971H thru NJH701975H, NJH701978H thru NJH701986H, NJH702007H, NJH702008H, NJH702028H, NJH702029H, NJH702032H, NJH702033H, NJH702035H, NJH702036H, NJH702038H, NJH702039H, NJH702044H, NJH702045H, NJH702144H, NJH702145H, NJH702146H, NJH702150H, NJH702152H, NJH702153H, NJH702157H, NJH702158H, NJH702159H, NJH702160H, NJH702162H, NJH702163H, NJH702164H, NJH702166H, NJH702168H, NJH702169H, NJH702171H thru NJH702175H, NJH702183H, NJH702184H, NJH702213H, NJH702215H, NJH702216H, NJH702263H, NJH702324H, NJH702425H, NJH702427H, NJH702428H, NJH702429H, NJH702434H, NJH702436H, NJH702438H, NJH702439H, NJH702441H, NJH702443H, NJH702447H, NJH702451H, NJH702452H, NJH702455H, NJH702458H, NJH702487H, NJH702765H, NJH702772H, NJH702809H, NJH702834H, NJH702852, NJH702862H, NJH702863H, NJH702919H, NJH702980, NJH702982H, NJH702990H, NJH702993H, NJH702999H, NJH703001H
RECALLING FIRM/MANUFACTURER
Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letter beginning on November 22, 2005, firm initiated recall is ongoing.
REASON
A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomaly can be corrected by reprogramming the Restore Neurostimulator using specific software.
VOLUME OF PRODUCT IN COMMERCE
101 devices
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Peak Conversion With Minerals Plus Selenium, 4 US Gallon Bottles/Case, Product Code #60150, Recall # V-075-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walco International, Inc., Westlake, TX, by telephone and letter on April 7, 2006.
Manufacturer: Y.S. Corp., Collinsville, AL. Firm initiated recall is ongoing.
REASON
Liquid mineral supplement intended for drinking water for swine and poultry contains selenium.
VOLUME OF PRODUCT IN COMMERCE
2,425 cases (4/ 1 gallon jugs per case)
DISTRIBUTION 
AL, AR, NC and TX

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

______________________________
PRODUCT
Mardel Maracyn, each tablet contains 200 mg. erythromycin activity, packaged 24 tablets in blister strips per inner folding carton (IFC), 12 inner folding cartons per intermediate case, 6 intermediate cases per master case. The master case label is labeled VIRBAC Maracyn 24 FW Tabs, 6 cartons/case, Item #01120, Recall # V-076-6
CODE
Lot 051617
RECALLING FIRM/MANUFACTURER
Recalling Firm: Virbac AH, Inc., Fort Worth, TX, by letters and fax on May 4, 2006.
Manufacturer: Virbac Corp., Bridgeton, MO. Firm initiated recall is ongoing.
REASON
Maracyn (erythromycin) tablets are packaged in Tetracycline tablet cartons.
VOLUME OF PRODUCT IN COMMERCE
43 master cases (containing 3,096/24-tablet inner folding cartons)
DISTRIBUTION 
NY, CA, FL, PA, WI, OH, NJ, IL, NC, MI and Canada

 

END OF ENFORCEMENT REPORT FOR MAY 31, 2006

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