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U.S. Department of Health and Human Services

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Enforcement Report for October 4, 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.

October 4, 2006
06-40

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

______________________________
PRODUCT
Amy's brand Amy's Whole Cheese Enchilada Meal in 9.0 oz. case, 12 units/case; UPC 42272 00057, Recall # F-327-6
CODE
B216A
RECALLING FIRM/MANUFACTURER
Amy's Kitchen, Inc., Santa Rosa, CA, by press release and letters on April 20, 2006. Firm initiated recall is ongoing.
REASON
Some packages labeled as Amy's Whole Meals, Cheese Enchiladas actually contain Black Bean Enchilada Whole Meals which include tofu, a soy ingredient.
VOLUME OF PRODUCT IN COMMERCE
160 cases/12 units/case
DISTRIBUTION
MA, NY, RI, NJ, NH, CT, VA, MD, PA, and DE

______________________________
PRODUCT
JHC Brand Cooked Seasoned Anchovy (Spicy), Net Wt: 7 oz. packed in clear plastic container, UPC # 6 67660 00202 9, Recall # F-328-6
CODE
No codes available on the product.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ustov, dba U.S. Trading Company, Hayward, CA, by press release and letters on December 22, 2005.
Manufacturer: Jack Hua Co. Ltd., Bangkok, Thailand. Firm initiated recall is complete.
REASON
Sample analysis by the San-DO Lab found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
27 cases - 24 containers/case
DISTRIBUTION
CA, AK, AZ, GA, ID, IA, IL, IN, MA, MI, MN, NB,OH, OR, and WI

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

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PRODUCT
Young's Seasoned Dried Anchovy keep refrigerated ingredients: Anchovy, Garlic, Sesame Seed, Corn Syrup, Hot Bean Paste, Vegetable Oil, Net wt. 5 oz. (141g) , Recall # F-329-6
CODE
All product that does not declare wheat as an ingredient.
RECALLING FIRM/MANUFACTURER
Center Oriental Food, Seattle, WA, by telephone on September 7, 2006. Firm initiated recall is complete.
REASON
Seasoned Dried Anchovy contains undeclared wheat flour.
VOLUME OF PRODUCT IN COMMERCE
196/5 oz. packages
DISTRIBUTION
WA

______________________________
PRODUCT
Wegmans Food You Feel Good About brand Country Wheat Hearty Sliced Bread, Net wt. 22 oz. (1 lb 6 oz), UPC 77890 84867, Recall # F-330-6
CODE
BEST IF USED BY 08/22
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by press release on August 23, 2006. Firm initiated recall is complete.
REASON
Firm received complaints from consumers that found pieces of cotton fabric in the bread.
VOLUME OF PRODUCT IN COMMERCE
6,330 loaves
DISTRIBUTION
NY, PA, NJ, VA, and MD

______________________________
PRODUCT
Kraft Miracle Whip Dressing; 32 fl. oz. glass jars, 12 jars per tray case; jar UPC #21000-64511. The Miracle Whip was shipped to warehouses in the following configurations: a) 12 jar shrink wrapped trays, UPC #210006451100; b) 70 case display module, module UPC 210003371600; c) 12 jar unwrapped trays, UPC 210007794800, which were components in the following display modules: i) a 29 case mixed module with cases of Kraft Mayonnaise, module UPC 210000126300 ii) a 50 case mixed module with cases of Kraft Miracle Whip Light Dressing, module UPC 210003371800, Recall # F-331-6;
Kraft Miracle Whip Light Dressing; 32 fl. oz. glass jars, 12 jars per case; jar UPC #21000-64592. The Miracle Whip Light was shipped to warehouses in the following configurations: a) 12 jar shrink wrapped trays, UPC #210006459200; b) 50 case display module, module UPC 210003371700, Recall # F-332-6;
Kraft Miracle Whip Free Nonfat Dressing; 32 fl. oz. glass jars, 12 jars per shrink wrapped tray case; jar UPC #21000-64512, tray UPC #210006451200, Recall # F-333-6;
Kraft Mayo Fat Free Mayonnaise Dressing; 32 fl. oz. glass jars, 12 jars per shrink wrapped tray case; jar UPC #21000-64012, tray UPC #210006401200, Recall # F-334-6
CODE
All affected product, case and module codes consist of a Best When Used By date code followed by a "C" or CX" a) 32 fl. oz. jar codes, UPC #21000-64511: 08 MAR 2007, 09 MAR 2007, 12 MAR 2007, 13 MAR 2007 and 14 MAR 2007; b) 12 jar shrink wrapped trays, UPC #210006451100, tray codes 08 MAR 2007, 09 MAR 2007, 12 MAR 2007, 13 MAR 2007 and 14 MAR 2007; c) 70 case display module, module UPC 210003371600, module code 12 MAR 2007; d) 12 jar unwrapped trays, UPC 210007794800, tray codes 08 MAR 2007 and 09 MAR 2007, which were components in the following display modules: i) a 29 case mixed module with cases of Kraft Mayonnaise, module UPC 210000126300, module codes 28 FEB 2007 and 08 MAR 2007; and ii) a 50 case mixed module with cases of Kraft Miracle Whip Light Dressing, module UPC 210003371800, module codes 08 JAN 2007, 18 JAN 2007 and 28 FEB 2007;
All affected product, case and module codes consist of a Best When Used By date code followed by a "C" or CX'' a) 32 fl. oz. jar codes, UPC #21000-64592: 07 MAR 2007; b) 12 jar shrink wrapped trays, UPC #210006459200, tray code 07 MAR 2007; c) 50 case display module, module UPC 210003371700, module code 15 MAR 2007;
c) Jar and Case code Best When Used By 05 JUN 2007, followed by a "C" or CX";
d) Jar and Case code Best When Used By 07 APR 2007, followed by a "C" or CX''
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc, NorthfieldIL, via e-mail, fax or visit on August 29, 2006,
Manufacturer Firm: Kraft Foods Inc-Enhancers Div, ChampaignIL. Firm initiated recall is ongoing.
REASON
Dressing and mayonnaise may be packaged in jars with defective rims.
VOLUME OF PRODUCT IN COMMERCE
65,167 -- 12 jar trays/cases
DISTRIBUTION
Nationwide

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PRODUCT
Bassett's brand Mint Chocolate Chip Ice Cream one pint (16 oz) containers. The product is shipped in clear plastic shrink wrapped sleeves which contain 8 pints, Recall # F-335-6
CODE
All codes prior to 236-06 are involved in the recall. The code is stamped on the bottom of the container in black ink. Any product having code 240-06 or higher has been properly labeled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bassetts Ice Cream Company, Philadelphia PA, by letter dated August 24, 2006.
Manufacturer: Galliker Dairy Co, Inc., Johnstown PA. Firm initiated recall is complete.
REASON
The product contains undeclared color - FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
2,120 units
DISTRIBUTION
DE, NJ, and PA

______________________________
PRODUCT
IGA Chicken Flavor Bouillon, 25 cubes, Net Wt. 3.33 ounce plastic jars, 12 jars per case; Distributed by IGA, Inc., Chicago, IL 60631-2773; UPC 0 41270 00958 4, Recall # F-336-6
CODE
The jars are labeled as IGA Chicken Flavor Bouillon, coded Best By JAN 2008 V06066. The shipping cases are labeled as 12-25 IGA Beef Blln Cube, UPC 0 41270 00957 7, Coded V06066
RECALLING FIRM/MANUFACTURER
Creative Contract Packaging Co., Aurora, IL, by press release, telephone and letters on August 17, 2006. Firm initiated recall is ongoing.
REASON
Jars labeled as chicken bouillon actually contain beef bouillon with soy as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
121 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

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PRODUCT
Oxygen, USP, Recall # D-368-6
CODE
Tanks with codes B-3807 through B-3950
RECALLING FIRM/MANUFACTURER
Alick's Home Medical Equipment, Inc., South Bend, IN, by home visit between August 7, 2005 and August 31, 2005. Firm initiated recall is complete.
REASON
Contaminated Medical Gas (Fluorine).
VOLUME OF PRODUCT IN COMMERCE
144 tanks
DISTRIBUTION
IN

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PRODUCT
WellPatch® Cough & Cold Soothing Vapor Pads, Camphor 5%, Eucalyptus oil 1.25%, Menthol, Natural 2.7%, Cough Suppressant, Orange Scented Mentholatum Gel Pad, 6 PADS per box, Each box contains 6 individually wrapped patches, NDC 10742-8134-1, UPC # 3 10742 01985 8, Stock # 1985, Recall # D-369-6.
CODE
Lots FE02A (exp. date 5/31/07), FE03A (exp. date 5/31/07), FE04A (exp. date 5/31/07), FE05A (exp. date 5/31/07), FE06A (exp. date 5/31/07), FE07A (exp. date 5/31/07), FE08A(exp. date 5/31/07), FE09A (exp. date 5/31/07), FF01A (exp. date 6/30/07), FG01A (exp. date 7/07/07), FG02A (exp. date 7/31/07), FG03A (exp. date 7/31/07), FG05A (exp. date 7/31/07), FH01A (exp. date 8/31/07), FH02A (exp. date 8/31/07)
RECALLING FIRM/MANUFACTURER
The Mentholatum Co., Inc., Orchard ParkNY, by press release on July 31, 2006, by letters dated August 2, 2006 and by e-mail on August 4, 2006.
Manufacturer: Mentholatum (China) Pharmaceuticals Co., Ltd., Guangdong
China (Mainland). Firm initiated recall is ongoing.
REASON
Misbranded; Use of the product on young children can pose health risks due to potential accidental ingestion.
VOLUME OF PRODUCT IN COMMERCE
172,152 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Novaplus label HydralAzine HCl Injection, USP, 20 mg/mL, 25 x 1 mL SINGLE DOSE VIALS, FOR INTRAMUSCULAR OR INTRAVENOUS USE, Sterile, Rx Only, NDC 0517-0911-25 . NOVAPLUS is a trademark of Novation LLC. --- RECALL EXPANSION: AMERICAN REGENT label HYDRALAZINE HYDROCHLORIDE INJECTION USP, 20 mg/mL, 25 X 1 mL SINGLE DOSE VIALS, FOR INTRAMUSCULAR OR INTRAVENOUS USE, Sterile, Rx Only, NDC 0517-0901-25, Recall # D-370-6
CODE
Lot 5561 NO (exp. date December 2006) , NDC 0517-0911-25; --- RECALL EXPANSION: additional lots under Novaplus label, NDC 0517-0911-25: Lot 5411 NO (exp. date September 2006), Lot 5457 NO (exp. date November 2006), 5669 NO (exp. date January 2007), Lot 5710 NO (exp. date February 2007), Lot 5784 NO (exp. date June 2007), Lot 5797 NO (exp. date June 2007), Lot 6411 NO (exp. date December 2007); Additional lots under American Regent Label, NDC 0517-0901-25: Lot 5411 (exp. date September 2006), Lot 5457 (exp. date November 2006), Lot 5552 (exp. date December 2006), Lot 5647 (exp. date January 2007), Lot 5669 (exp. date January 2007), Lot 5753 (exp. date March 2007), Lot 6411 (exp. date December 2007)
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letter dated July 24, 2006 and by e-mail or fax on July 24, 2006. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
180,450 vials; Recall Expansion: 1,567,025 vials
DISTRIBUTION
Nationwide, PR and Guam

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Levoxyl (Levothyroxine sodium tablets, USP) 112mcg, Rx, Item #537845. The medication is repackaged and distributed in 100 tablet bottles, Recall # D-357-6
CODE
Lot Number: 053668, Expiration Date: 09/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by e-mail and letters on August 17, 2006.
Manufacturer: King Pharmaceuticals, Inc., (St. Petersburg Facility), Saint Petersburg, FL. Firm initiated recall is ongoing.
REASON
Subpotent: The tablets have the potential to fall below the manufacturer's potency specifications before their labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
1,007 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Walgreen's brand Wal-phed PE Caplets, Acetaminophen 325 mg and Phenylephrine HCI 5 mg, 24 count package, OTC; NDC 0363-0502-08; UPC 1191707632; Walgreen's Item # 501485, Recall # D-371-6
CODE
Lots: P40244 (exp. date 4/08), P40245 (exp. date 4/08) P40977 (exp. date 5/08)
RECALLING FIRM/MANUFACTURER
LNK International, Inc., Hauppauge, NY, by letter, fax, e-mail and Certified Mail on September 18, 2006. Firm initiated recall is ongoing.
REASON
Labeling Error: Drugs Facts panel incorrectly states: “When using this product -- do exceed recommended dosage”. The word NOT was accidentally omitted from the 2nd portion of the phrase. The Directions section does provide the correct dosing instructions.
VOLUME OF PRODUCT IN COMMERCE
94,896 boxes (24 caplets per box)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1814-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1815-6;
c) Fresh Frozen Plasma, Recall # B-1816-6;
d) Recovered Plasma, Recall # B-1817-6
CODE
a) Unit: 6802184;
b) Units: 6840564, 4683768, 4700389;
c) Unit: 4683768;
d) Units: 6840564, 4700389
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Tyler, TX, by telephone and fax on October 7, 2003 and October 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Medi-Temp III, Blood and Fluid Warmer, Model Number FW600, Model Number FW601, Model Number FW603, Recall # B-1794-6
CODE
Model Number FW600:
A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30010, A30011, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30021, A30022, A30023, A30024, A30025, A30027, A30030, A30031, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B20015, B20016, B20017, B20018, B20020, B20021, B20022, B20023, B20024, B20025, B20026, B20027, B20028, B20029, B20030, B20031, B20032, B20033, B20034, B20035, B20036, B20037, B20038, B20039, B20040, B20043, B20044, B20045, B20046, B20047, B20048, B20049, B20050, B20051, B20052, B20053, B20054, B20055, B20056, B20057, B20058, B20059, B20060, B20061, B20062, B20063, B20064, B20065, B20066, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30019, B30020, B30021, B30022, B30023, B30024, B30025, B30026, B30027, B30028, B30029, B30030, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C20017, C20018, C20019, C20020, C20021, C20022, C20023, C20024, C20025, C20026, C20027, C20028, C20029, C20030, C20031, C20032, C20033, C20034, C20036, C20037, C20038, C20039, C20041, C20042, C20043, C20044, C20045, C20046, C20047, C20049, C20050, C20051, C20053, C20054, C20055, C20056, C20057, C20058, C20059, C20060, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30020, C30021, C30022, C30023, C30024, C30025, C30026, C30027, C30028, C30029, C30030, C30031, C30032, C30033, C30034, C30035, C30036, C30037, C30038, C30039, C30040, C30041, C30042, C30043, C30044, C30045, C30046, C30047, C30048, C30049, C30050, C30051, C30052, C30053, C30054, C30055, C30056, C30057, C30058, C30059, C30060, C40001, C40002, C40003, C40004, C40005, C40006, C40007, C40008, C40009, C40010, C40011, C40012, C40013, C40014, C40015, C40016, C40017, C40018, C40019, C40020, C40021, C40022, C40023, C40024, C40025, C40026, C40027, C40028, C40029, C40030, C40031, C40032, C40033, C40034, C40035, C40036, C40037, C40038, C40039, C40040, C40041, C40042, C40043, C40044, C40045, C40046, C40047, C40048, C40049, C40050, C40051, C40052, C40053, C40054, C40055, C40056, C40057, C40058, C40059, C40061, C40062, C40063, C40064, C40065, C40066, C40067, C40068, C40069, C40070, C40071, C40072, C40073, C40074, C40075, C40076, C40077, C40078, C40079, C40080, C40081, C40082, C40083, C40084, C40085, C40086, C40087, C40088, C40089, C40090, C40091, C40092, C40093, C40094, C40095, C40096, C40097, C40098, C40099, C40100, C40101, C40102, C40103, C40104, C40105, C40106, C40107, C40108, C40109, C40110, C40111, C40112, C40113, C40114, C40115, C40116, C40117, C40118, C40119, C40120, C40121, C40122, C40123, C40124, C40125, C40126, C40127, C40128, C40129, D30001, D30002, D30003, D30004, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30021, E20001, E20002, E20004, E20005, E20007, E20008, E20009, E20010, E20011, E20012, E20017, E20018, E20019, E20020, E20021, E20022, E20024, E20025, E20027, E20028, E20030, E20031, E20032, E20033, E30002, E30003, E30004, E30005, E30006, E30007, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F20015, F20016, F20017, F20018, F20019, F20020, F20021, F20022, F20023, F20024, F20025, F20027, F20028, F20029, F20030, F20031, F20032, F20033, F20034, F20035, F20036, F20037, F20038, F20039, F20040, F20041, F20042, F20043, F20044, F20045, F20046, F20047, F20048, F20049, F20050, F20051, F20052, F20053, F20054, F20055, F20056, F20057, F20058, F20059, F20060, F20061, F20062, F20063, F20064, F20065, F20066, F20067, F20068, F20069, F20070, F20071, F20072, F20073, F20074, F20076, F20077, F20078, F20080, F20081, F20082, F20083, F20084, F20085, F20086, F20087, F20088, F20089, F20090, F20091, F20092, F20093, F20094, F20095, F20096, F20097, F20098, F20099, F20101, F20102, F20103, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30020, F30021, F30022, F30023, F30025, F30026, F30027, F30028, F30029, F30030, F30031, F30032, F30033, F30034, F30035, F30036, F30037, F30038, F30039, F30040, F30041, F30042, F30043, F30044, F30045, F30047, F30048, F30050, F30052, F30053, F30054, F30056, F30057, F30058, F30059, F30060, F30061, F30062, F30063, F30064, F30066, F30067, F30068, F30069, F30070, F30071, F30072, F30073, F30074, F30076, F30077, F30078, F30079, F30081, F30082, F30083, F30084, F30086, F30087, F30088, F30089, F30090, F30091, F30092, F30093, F30094, F30095, F30096, F30097, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G20021, G20022, G20023, G20024, G20025, G20026, G20027, G20028, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, G30011, G30012, G30013, G30014, G30015, G30016, G30017, G30018, G30019, G30020, G30021, G30022, G30023, G30024, G30025, G30026, G30027, G30028, G30029, G30030, G30031, G30032, G30033, G30034, G30035, G30036, G30037, G30038, G30039, G30040, G30041, G30042, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20016, H20017, H20018, H20019, H20020, H20021, H20022, H20023, H20024, H30001, H30002, H30003, H30004, H30005, H30006, H30007, H30008, H30010, H30011, H30012, H30013, H30014, H30015, H30016, H30017, H30018, H30019, H30020, H30022, H30023, H30024, H30025, H30026, H30027, H30028, H30029, H30030, H30031, H30032, H30033, H30034, H30035, H30036, H30037, H30038, H30039, H30040, H30041, H30042, H30043, H30044, H30045, H30046, H30047, H30048, H30049, H30050, H30051, H30052, H30053, H30054, H30055, H30056, H30057, H30058, H30059, H30060, H30061, H30062, H30063, H30064, H30065, H30066, H30067, H30068, H30069, H30070, H30071, H30072, H30073, I20001, I20002, I20003, I20005, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I20024, I20025, I20026, I20027, I20028, I20029, I20030, I20031, I20032, I20033, I20035, I20036, I20037, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, J20001, J20002, J20003, J20004, J20005, J20006, J20007, J20008, J20009, J20010, J20011, J20012, J20013, J20014, J20015, J20016, J20017, J20018, J20019, J20020, J20021, J20022, J20023, J20024, J20025, J20026, J20027, J20028, J20029, J20030, J20031, J20032, J20033, J20034, J20035, J20036, J20037, J20038, J20039, J20040, J20042, J20043, J20044, J20045, J20048, J20049, J20050, J20051, J20052, J30001, J30002, J30003, J30004, J30006, J30007, J30008, J30009, J30010, J30011, J30012, J30013, J30014, J30015, J30016, J30017, J30020, J30021, J30022, J30023, J30024, J30025, J30026, J30027, J30028, J30029, J30030, J30031, J30032, J30033, J30034, J30035, J30036, J30037, J30038, J30039, J30040, J30041, J30042, J30043, J30044, J30045, J30046, J30047, J30048, J30049, J30050, J30051, J30052, J30053, J30054, J30055, J30056, J30057, J30058, J30059, J30060, J30061, J30062, J30063, J30064, J30065, J30066, J30067, J30068, J30069, J30070, J30071, J30072, J30073, J30074, J30075, J30076, J30077, J30079, J30080, J30081, J30082, K10003, L10001, L20001, L20002, L20004, L20005, L20006, L20007, L20008, L20009, L20011, L20012, L20013, L20014, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L20030;
Model Number FW601:
C40001, C40002, C40003, C40004, C40005, C40006, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020
Model Number FW603:
A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A20015, A20016, A20017, A20018, A20019, A20020, A20021, A20022, A20023, A20024, A20025, A20026, A20027, A20028, A20029, A20030, A20031, A20032, A20033, A20034, A20035, A20036, A20037, A30001, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30026, A30027, A30028, A30029, A30030, A30031, A30032, A30033, A30034, A30040, A30041, A30042, A30043, A30044, A30045, A30046, A30047, A30048, A30051, A30052, A30053, A30055, A30056, A30057, A30058, A30059, A30060, A30061, A30062, A30063, A30064, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, A40010, A40011, A40012, A40013, A40014, A40015, A40016, A40017, A40018, A40019, A40020, A40021, A40022, A40023, A40024, A40025, A40026, A40027, A40028, A40029, A40030, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30011, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30020, B30021, B30022, C20001, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30021, D30001, D30002, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30026, D30027, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020, D40021, D40022, D40023, D40024, D40025, D40026, D40027, E20001, E20002, E20003, E20004, E30001, E30002, E30003, E30004, E30005, E30006, E30007, E30008, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30019, F30020, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20012, H20013, I20001, I20002, I20003, I20004, I20005, I20006, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20015, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30018, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, I30027, I30028, I30029, I30030, I30031, I30032, I30033, I30034, I30035, I30036, K10001, K10002, K10003, L20001, L20002, L20003, L20004, L20005, L20006, L20007, L20008, L20009, L20010, L20011, L20012, L20013, L20014, L20015, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L30001, L30002, L30003, L30004, L30005, L30006, L30007, L30008, L30009, L30010, L30011, L30012
RECALLING FIRM/MANUFACTURER
Gaymar Industries, Inc., Orchard Park, NY, by letters from February 14 -- 24, 2006. Firm initiated recall is complete.
REASON
Blood and Fluid Warmers, manufactured with a defective label on the front panel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
752 units Domestic; 883 units Foreign
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Terumo Khuri Myocardial PH Monitoring System, Catalog number 7205, Recall # Z-1517-06
CODE
Lots: 2006-06AD, 2006-08AD, 2006-OSAP, 60SAP608AD
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Tustin, CA, by letters on June 23, 2006. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: These specific lots of sensors lack supporting documentation for sterilization assurance.
VOLUME OF PRODUCT IN COMMERCE
175 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637, Recall # Z-1524-06
CODE
Lot numbers: 444881 and 445348
RECALLING FIRM/MANUFACTURER
Kerr Corp., Orange CA, by letter on August 14, 2006 and by fax on August 16, 2006. Firm initiated recall is ongoing.
REASON
Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured).
VOLUME OF PRODUCT IN COMMERCE
1,516 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950, Recall # Z-1525-06
CODE
Lot: 5312395, 5312394; Lot: 5319508 and 5300175
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Co., Franklin Lakes, NJ, by letters on July 28, 2006.
Manufacturer: BD Medical -- Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON
BD received reports of needle assembly disengagement from the syringe.
VOLUME OF PRODUCT IN COMMERCE
1,294,200 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery, Recall # Z-1526-06
CODE
Lot: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
RECALLING FIRM/MANUFACTURER
Ogenix Corporation, Cleveland, OH, by telephone on March 24, 2006. Firm initiated recall is complete.
REASON
Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.
VOLUME OF PRODUCT IN COMMERCE
518 units
DISTRIBUTION
IN, MD, TX, MA, MI, MN, OH, FL, and NB

______________________________
PRODUCT
a) Allegiance Esmark 4” x 108” Bandage, Latex Free, Sterile;
36 bandages per case; Individually wrapped for single patient use,
Contents Sterile if Unopened, Undamaged; Catalog 24593-043A,
Recall # Z-1527-06;
b) Allegiance Esmark 4” x 144” Bandage, Latex Free, Sterile;
36 bandages per case; Individually wrapped for single patient use,
Contents Sterile if Unopened, Undamaged; Catalog 24593-044A,
Recall # Z-1528-06;
c) Allegiance Esmark 6” x 108” Bandage, Latex Free, Sterile;
36 bandages per case; Individually wrapped for single patient use,
Contents Sterile if Unopened, Undamaged; Catalog 24593-063A,
Recall # Z-1529-06;
d) Allegiance Esmark 6” x 144” Bandage, Latex Free, Sterile;
36 bandages per case; Individually wrapped for single patient use,
Contents Sterile if Unopened, Undamaged; Catalog 24593-064A,
Recall # Z-1530-06;
CODE
a) Lot: 06-2071-1;
b) Lot: 06-2071-1;
c) Lot: 06-1990-1;
d) Lot: 06-2071-1;
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Medsurg Connection, Inc., Schaumburg, IL, by telephone on August 16, 2006 and follow-up letter dated August 24, 2006.
Manufacturer: Texstrip Manufacturing, Sdn Bhd, Selangor Daru Pehsan, Malaysia. Firm initiated recall is ongoing.
REASON
The bandages labeled as sterile had not been sterilized prior to distribution.
VOLUME OF PRODUCT IN COMMERCE
572 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Codman External Drainage System 3 CSF (EDS 3)
With Ventricular Catheter Catalog Number: 82-1730,
Recall # Z-1533-06;
b) Codman External Drainage System 3 CSF (EDS 3)
Without Ventricular Catheter Catalog Number: 82-1731,
Recall # Z-1534-06
CODE
a) Lot: CGHBKY;
b) Lot: CGGCVB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Codman & Shurtleff, Inc., Raynham, MA, by telephone and fax on August 4, 2006.
Manufacturer: Codman Sarl, Lelocle, Switzerland. Firm initiated recall is ongoing.
REASON
Sterility of device is compromised due to package seal defects.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
NICO Model 7300 Cardiopulmonary Management System, Recall # Z-1535-06
CODE
All serial numbers beginning with 138.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Respironics Novametrix, LLC, Wallingford CT, by letter on August 28, 2006.
Manufacturer: Respironics California, Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON
Audible alarm may not sound during an alert condition
VOLUME OF PRODUCT IN COMMERCE
2,432 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Micrus brand WATUSI Guidewire 0.014” -- Soft Tip, Catalog Number: WST 140205-00, Recall # Z-1542-06
CODE
Lot numbers: F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749
RECALLING FIRM/MANUFACTURER
Recalling Firm: Micrus Endovascular Corporation, San Jose, CA, by letters on September 8, 2006.
Manufacturer: Lake Region Manufacturing, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
During use, the introducer may cause the guide wire's coating to strip off and may result in loose material which could break free and enter the blood stream.
VOLUME OF PRODUCT IN COMMERCE
413 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122), Recall # Z-1550-06
CODE
Lots 175646 and 174558
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., IndianapolisIN, by letter dated September 15, 2006.
Manufacturer: Roche Diagnostics GmbH, PenzbergIndiana, Germany. Firm initiated recall is ongoing.
REASON
Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.
VOLUME OF PRODUCT IN COMMERCE
5,688 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Medline Strider Midi 3 Scooter; a three wheeled battery operated
scooter; model MDS807500 -- red and MDS807500B -- blue,
Recall # Z-1522-06;
b) Medline Strider Midi 4 Scooter; a four wheeled battery operated
scooter; model MDS807550 - red and MDS807550B -- blue,
Recall # Z-1523-06
CODE
a) Model MDS807500 - red and model MDS807500B - blue, scooter no., controller no.: EV10DB-*US00110*,13010613; EV10DB-*US00102*,13010615; EV10DB-*US00103*,53010802; EV10DB-*US00101*,53010803; EV10DB-*US00106*,53010806; EV10DB-*US00107*,53010807; EV10DB-*US00111*,53011072; EV10DB-*US00118*,53050871; EV10DB-*US00112*,53050872; EV10DB-*US00115*,53050873; EV10DB-*US00116*,53050874; EV10DB-*US00117*,53050875; EV10DB-*US00105*,73010706; EV10DB-*US00108*,73010710; EV10DB-*US00109*,73010711; EV10DB-*US00119*,73050684; EV10DB-*US00113*,73050685; EV10DB-*US00120*,73050686; EV10DB-*US00121*,73050688; EV10DB-*US00130*,73050805; EV10DB-*US00123*,73050806; EV10DB-*US00127*,73050807; EV10DB-*US00126*,73050808; EV10DB-*US00129*,73050809; EV10DB-*US00128*,73050810; EV10DB-*US00125*,73050812; EV10DB-*US00122*,73060000; EV10DB-*US00151*,13010484; EV10DB-*US00131*,23010651; EV10DB-*US00137*,33010608; EV10DB-*US00133*,53010863; EV10DB- *US00152*,53010928; EV10DB-*US00135*,53010929; EV10DB-*US00157*,53050630; EV10DB-*US00155*,53050631; EV10DB-*US00153*,53050632; EV10DB-*US00142*,53050865; EV10DB-*US00143*,53050866; EV10DB-*US00149*,53050867; EV10DB-*US00145*,53050868; EV10DB-*US00140*,53050869; EV10DB-*US00146*,53050870; EV10DB-*US00132*,73010716; EV10DB-*US00136*,73010765; EV10DB-*US00150*,73010824; EV10DB-*US00138*,73010825; EV10DB-*US00156*,73050441; EV10DB-*US00159*,73050443; EV10DB-*US00158*,73050444; EV10DB-*US00147*,73050680; EV10DB-*US00148*,73050681; EV10DB-*US00141*,73050682; EV10DB-*US00139*,73050683; EV10DB-*US00160*,73050442; EV10DB-*UK00150*,53010988; EV10DB-*UK00155*,53010676; EV10DB-*UK00158*,53010677; EV10DB-*UK00163*,73010884; EV10DB-*UK00173*,13010532; EV10DB-*UK00179*,53010668; EV10DB-*UK00181*,53010670; EV10DB-*UK00189*,13010530; EV10DB-*UK00192*,73010599; EV10DB-*UK00195*,53010791; EV10DB-*UK00200*,53010785; EV10DB-*UK00202*,53010789; EV10DB-*UK00203*,53010847; EV10DB-*UK00205*,73010750; EV10DB-*UK00206*,73010749; EV10DB-*UK00209*,53010787; EV10DB-*UK00220*,73010780; EV10DB-*UK00222*,53010776; EV10DB-*UK00227*,33010692; EV10DB-*UK00228*,73010691; EV10DB-*UK00230*,53010779; EV10DB-*UK00231*,73010689; EV10DB-*UK00232*,43010700; EV10DB-*UK00233*,53010788; EV10DB-*UK00236*,33010695; EV10DB-*UK00241*,13010525; EV10DB-*UK00248*,53010908; EV10DB-*UK00251*,33010620; EV10DB-*UK00252*,73010802; EV10DB-*UK00253*,53010907; EV10DB-*UK00256*,33010625; EV10DB-*UK00261*,23010532; EV10DB-*UK00265*,43010632; EV10DB-*UK00268*,73010628; EV10DB-*UK00270*,53010698; EV10DB-*UK00272*,53010688; EV10DB-*UK00276*,53010687; EV10DB-*UK00278*,23010545; EV10DB-*UK00279*,13010528; EV10DB-*UK00282*,23010533; EV10DB-*UK00286*,23010531; EV10DB-*UK00289*,73010616; EV10DB-*UK00292*,43010832; EV10DB-*UK00297*,33010838; EV10DB-*UK00298*,33010839; EV10DB-*UK00299*,43010831; EV10DB-*UK00303*,53010962; EV10DB-*UK00307*,73010859; EV10DB-*UK00309*,43010808; EV10DB-*UK00310*,43010807; EV10DB-*UK00311*,33010810; EV10DB-*UK00313*,43010811; EV10DB-*UK00315*,13010609; EV10DB-*UK00319*,43010809; EV10DB-*UK00326*,33010808; EV10DB-*UK00330*,73010858; EV10DB-*UK00341*,43010238; EV10DB-*UK00349*,53010825; EV10DB-*UK00359*,73010665; EV10DB-*UK00360*,53010738; EV10DB-*UK00361*,73010663; EV10DB-*UK00366*,73010871; EV10DB-*UK00367*,53010734; EV10DB-*UK00370*,73010776; EV10DB-*UK00376*,53010876; EV10DB-*UK00383*,43010232; EV10DB-*UK00385*,73010651; EV10DB-*UK00390*,43010602; EV10DB-*UK00398*,33010591; EV10DB-*UK00400*,33010592; EV10DB-*UK00403*,53010978; EV10DB-*UK00409*,53010722; EV10DB-*UK00411*,53010909; EV10DB-*UK00421*,23010568; EV10DB-*UK00425*,13010562; EV10DB-*UK00426*,13010563; EV10DB-*UK00429*,13010503; EV10DB-*UK00430*,73010588; EV10DB-*UK00431*,13010561; EV10DB-*UK00432*,53010914; EV10DB-*UK00433*,73010810; EV10DB-*UK00435*,53010910; EV10DB-*UK00446*,43010624; EV10DB-*UK00452*,73010754; EV10DB-*UK00461*,43010695; EV10DB-*UK00475*,53050530; EV10DB-*UK00477*,73050341; EV10DB-*UK00479*,73050344; EV10DB-*UK00487*,73050676; EV10DB-*UK00490*,43050817; EV10DB-*UK00492*,53050898; EV10DB-*UK00500*,73050732; EV10DB-*UK00501*,73050729; EV10DB-*UK00502*,73050733; EV10DB-*UK00505*,73050678; EV10DB-*UK00507*,53050915; EV10DB-*UK00510*,43050821; EV10DB-*UK00512*,53050914; EV10DB-*UK00521*,73050460; EV10DB-*UK00529*,53050677; EV10DB-*UK00560*,73050719; EV10DB-*UK00581*,53050826; EV10DB-*UK00582*,43050567; EV10DB-*UK00583*,43050806; EV10DB-*UK00595*,53050881; EV10DB-*UK00598*,73050693; EV10DB-*UK00600*,73050311; EV10DB-*UK00606*,73050696; EV10DB-*UK00613*,43050804; EV10DB-*UK00619*,73050387; EV10DB-*UK00621*,53050577; EV10DB-*UK00623*,53050576; EV10DB-*UK00627*,73050495; EV10DB-*UK00628*,53050687; EV10DB-*UK00629*,73050500; EV10DB-*UK00630*,73050497; EV10DB-*UK00636*,53050686; EV10DB-*UK00637*,73050462; EV10DB-*UK00639*,53050655; EV10DB-*UK00640*,53050618; EV10DB-*UK00643*,53050617; EV10DB-*UK00645*,73050508; EV10DB-*UK00648*,53050699; EV10DB-*UK00653*,53050654; EV10DB-*UK00655*,53050697; EV10DB-*UK00657*,53050696; EV10DB-*UK00659*,43050572; EV10DB-*UK00660*,53050653; EV10DB-*UK00661*,73050467; EV10DB-*UK00666*,73050468; EV10DB-*UK00668*,43050809; EV10DB-*UK00670*,53050906; EV10DB-*UK00671*,43050812; EV10DB-*UK00673*,73050456; EV10DB-*UK00675*,53050644; EV10DB-*UK00676*,73050455; EV10DB-*UK00678*,33050776; EV10DB-*UK00679*,53050890; EV10DB-*UK00680*,43050811; EV10DB-*UK00681*,43050813; EV10DB-*UK00683*,73050720; EV10DB-*UK00685*,53050908; EV10DB-*UK00687*,53050929; EV10DB-*UK00689*,53050579; EV10DB-*UK00691*,73050394; EV10DB-*UK00693*,53050580; EV10DB-*UK00695*,73050324; EV10DB-*UK00696*,73050392; EV10DB-*UK00698*,43050457; EV10DB-*UK00699*,53050924; EV10DB-*UK00700*,73050737; EV10DB-*UK00701*,53050926; EV10DB-*UK00702*,73050741; EV10DB-*UK00703*,53050925; EV10DB-*UK00706*,73050742; EV10DB-*UK00709*,53050646; EV10DB-*UK00712*,73050740; EV10DB-*UK00713*,53050907; EV10DB-*UK00717*,73050722; EV10DB-*UK00721*,73050381; EV10DB-*UK00723*,53050571; EV10DB-*UK00725*,43050837; EV10DB-*UK00726*,33050793; EV10DB-*UK00727*,53050922; EV10DB-*UK00730*,33050794; EV10DB-*UK00731*,33050431; EV10DB-*UK00733*,73050383; EV10DB-*UK00736*,53050611; EV10DB-*UK00737*,33050792; EV10DB-*UK00739*,73050382; EV10DB-*UK00740*,73050420; EV10DB-*UK00741*,73050323; EV10DB-*UK00742*,53050509; EV10DB-*UK00743*,73050422; EV10DB-*UK00746*,73050325; EV10DB-*UK00747*,53050508; EV10DB-*UK00748*,73050659; EV10DB-*UK00750*,53050511; EV10DB-*UK00753*,73050321; EV10DB-*UK00755*,53050612; EV10DB-*UK00756*,73050421; EV10DB-*UK00758*,73050419; EV10DB-*UK00760*,73050347; EV10DB-*UK00761*,73050346; EV10DB-*UK00762*,53050534; EV10DB-*UK00763*,73050658; EV10DB-*UK00766*,43050857; EV10DB-*UK00767*,43050432; EV10DB-*UK00768*,53050935; EV10DB-*UK00769*,43050434; EV10DB-*UK00770*,43050430; EV10DB-*UK00771*,73050652; EV10DB-*UK00773*,73050744; EV10DB-*UK00777*,53050844; EV10DB-*UK00778*,53050934; EV10DB-*UK00781*,73050384; EV10DB-*UK00782*,53050568; EV10DB-*UK00785*,53050569; EV10DB-*UK00786*,73050747; EV10DB-*UK00788*,53050536; EV10DB-*UK00789*,53050613; EV10DB-*UK00791*,73050348; EV10DB-*UK00792*,43050854; EV10DB-*UK00795*,53050837; EV10DB-*UK00797*,53050610; EV10DB-*UK00800*,73050423; EV10DB-*UK00805*,73050385; EV10DB-*UK00808*,43050433; EV10DB-*UK00809*,33050430; EV10DB-*UK00811*,53050931; EV10DB-*UK00812*,53050535; EV10DB-*UK00816*,43050856; EV10DB-*UK00817*,73050738; EV10DB-*UK00818*,53050538; EV10DB-*UK00819*,33050429;

b) Model MDS807550 - red and model MDS807550B - blue, Scooter no., controller no.:EV10DA-*US00108*,23010640; EV10DA-*US00113*,33010241; EV10DA-*US00121*,33010242; EV10DA-*US00127*,33010243; EV10DA-*US00117*,33010244; EV10DA-*US00112*,33010245; EV10DA-*US00129*,33010806; EV10DA-*US00123*,43010239; EV10DA-*US00119*,43010240; EV10DA-*US00118*,43010241; EV10DA-*US00120*,43010242; EV10DA-*US00116*,43010243; EV10DA-*US00128*,43010813; EV10DA-*US00125*,53010812; EV10DA-*US00122*,53010813; EV10DA-*US00130*,53011070; EV10DA-*US00148*,53050909; EV10DA-*US00152*,53050910; EV10DA-*US00155*,53050911; EV10DA-*US00146*,53050912; EV10DA-*US00153*,53050913; EV10DA-*US00110*,53050937; EV10DA-*US00101*,53050938; EV10DA-*US00126*,73010717; EV10DA-*US00147*,73050724; EV10DA-*US00150*,73050725; EV10DA-*US00145*,73050726; EV10DA-*US00149*,73050727; EV10DA-*US00151*,73050728; EV10DA-*US00103*,73050748; EV10DA-*US00109*,73050749; EV10DA-*US00136*,73050750; EV10DA-*US00102*,73050786; EV10DA-*US00106*,73050787; EV10DA-*US00107*,73050788; EV10DA-*US00111*,73050789; EV10DA-*US00115*,73050790; EV10DA-*US00105*,73050791; EV10DA-*US00135*,73050792; EV10DA-*US00137*,73050793; EV10DA-*US00139*,73050794; EV10DA-*US00141*,73050795; EV10DA-*US00142*,73050796; EV10DA-*US00138*,73050797; EV10DA-*US00143*,73050798; EV10DA-*US00133*,73050799; EV10DA-*US00140*,73050800; EV10DA-*US00132*,73050811; EV10DA-*US00131*,73060001; EV10DA-*US00160*,43010614; EV10DA-*US00159*,53010814; EV10DA-*US00157*,53010866; EV10DA-*US00158*,53011075; EV10DA-*US00156*,73010768; EV10DA-*US00162*,33010606; EV10DA-*US00165*,43010805; EV10DA-*US00163*,53010637; EV10DA-*US00167*,D49840/3 73010564; EV10DA-*US00221*,13010485; EV10DA-*US00225*,23010490; EV10DA-*US00223*,53010638;
EV10DA-*US00222*,73010565; EV10DA-*UK00221*,43010782; EV10DA-*UK00227*,43010736; EV10DA-*UK00228*,43010733; EV10DA-*UK00232*,33010755; EV10DA-*UK00236*,33010797; EV10DA-*UK00240*,53011045; EV10DA-*UK00242*,73010819; EV10DA-*UK00248*,13010491; EV10DA-*UK00249*,53010926; EV10DA-*UK00257*,53010925; EV10DA-*UK00260*,53010923; EV10DA-*UK00266*,53010927; EV10DA-*UK00269*,53010830; EV10DA-*UK00271*,43010586; EV10DA-*UK00272*,53010829; EV10DA-*UK00275*,33010573; EV10DA-*UK00292*,53010861; EV10DA-*UK00310*,53011092; EV10DA-*UK00311*,53011085; EV10DA-*UK00315*,33020062; EV10DA-*UK00320*,53020055; EV10DA-*UK00321*,73010881; EV10DA-*UK00325*,73010563; EV10DA-*UK00336*,23010487; EV10DA-*UK00339*,13010481; EV10DA-*UK00345*,73010684; EV10DA-*UK00353*,73010688; EV10DA-*UK00357*,53010784; EV10DA-*UK00370*,53010634; EV10DA-*UK00373*,53010904; EV10DA-*UK00381*,43010587; EV10DA-*UK00383*,33010645; EV10DA-*UK00385*,73010798; EV10DA-*UK00409*,33010676; EV10DA-*UK00416*,43010680; EV10DA-*UK00420*,33010643; EV10DA-*UK00428*,73010703; EV10DA-*UK00432*,73010702; EV10DA-*UK00435*,53010844; EV10DA-*UK00448*,53010870; EV10DA-*UK00449*,13010496; EV10DA-*UK00459*,73010922; EV10DA-*UK00729*,53010726; EV10DA-*UK00733*,43010644; EV10DA-*UK00737*,43010648; EV10DA-*UK00748*,33010639; EV10DA-*UK00777*,43010692; EV10DA-*UK01382*,53050664; EV10DA-*UK01421*,43050439; EV10DA-*UK01516*,43050568; EV10DA-*UK01567*,73050340; EV10DA-*UK01570*,53050749; EV10DA-*UK01580*,33050609; EV10DA-*UK01582*,53050748; EV10DA-*UK01583*,73050568; EV10DA-*UK01589*,53050757; EV10DA-*UK01590*,73050563; EV10DA-*UK01593*,73050566; EV10DA-*UK01595*,43050625; EV10DA-*UK01599*,53050758; EV10DA-*UK01601*,43050624; EV10DA-*UK01603*,73050576; EV10DA-*UK01611*,33050640; EV10DA-*UK01612*,73050501; EV10DA-*UK01616*,33050638; EV10DA-*UK01626*,43050639; EV10DA-*UK01640*,43050427; EV10DA-*UK01641*,73050376; EV10DA-*UK01645*,53050545; EV10DA-*UK01651*,33050437; EV10DA-*UK01652*,33050425; EV10DA-*UK01656*,73050379; EV10DA-*UK01657*,53050544; EV10DA-*UK01658*,43050438; EV10DA-*UK01661*,53050566; EV10DA-*UK01662*,73050356; EV10DA-*UK01665*,33050426; EV10DA-*UK01666*,73050377; EV10DA-*UK01669*,53050659; EV10DA-*UK01672*,73050309; EV10DA-*UK01673*,33050642; EV10DA-*UK01679*,73050471; EV10DA-*UK01680*,53050661; EV10DA-*UK01683*,73050308; EV10DA-*UK01686*,33050625; EV10DA-*UK01687*,73050472; EV10DA-*UK01688*,53050495; EV10DA-*UK01689*,73050307; EV10DA-*UK01690*,53050494; EV10DA-*UK01695*,73050306; EV10DA-*UK01700*,73050310; EV10DA-*UK01701*,73050579; EV10DA-*UK01703*,53050820; EV10DA-*UK01708*,53050761; EV10DA-*UK01711*,53050786; EV10DA-*UK01713*,73050492; EV10DA-*UK01716*,53050679; EV10DA-*UK01719*,53050764; EV10DA-*UK01721*,53050668; EV10DA-*UK01722*,43050635; EV10DA-*UK01745*,53050787; EV10DA-*UK01763*,43050840; EV10DA-*UK01766*,33050796; EV10DA-*UK01770*,33050773; EV10DA-*UK01776*,53050887; EV10DA-*UK01778*,53050884; EV10DA-*UK01779*,73050734; UK01421, D50574.02 AU04101795
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc., Mundelein, IL, by letters dated July 20, 2006.
Manufacturer: Kwang Yang Motor Co., Ltd., Kaohsiung, Taiwan, Republic of China. Firm initiated recall is ongoing.
REASON
The P&G Solo 60A electronic control unit on the Midi Scooters may overheat.
VOLUME OF PRODUCT IN COMMERCE
439 scooters
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) ActiveLife One-Piece Pre-Cut Closed End (ostomy)
Pouch with skin barrier and filter 45mm (box of 15)
1 ¾” 45mm; REF 175772; UPC 00031 75772,
Recall # Z-1531-06;
b) ActiveLife One-Piece Pre-Cut Closed End (ostomy)
Pouch with skin barrier and filter 45mm (box of 60)
1 ¾” 45mm; REF 413145; UPC 0034 131445,
Recall # Z-1532-06
CODE
a) and b) Lot number: 6E3589N
RECALLING FIRM/MANUFACTURER
Conva Tec, Skillman, NJ, by letter on July 31, 2006. Firm initiated recall is ongoing.
REASON
Cartons may contain one or more units that are 1 ½” size rather than 1 ¾” size as indicated on the label.
VOLUME OF PRODUCT IN COMMERCE
716 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit
for Spinal Cord Stimulation (SCS), Recall # Z-1536-06;
b) Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance
Lead Kit for Spinal Cord Stimulation (SCS),
Recall # Z-1537-06
CODE
a) Lot: V009545;
b) Lot: V009546
RECALLING FIRM/MANUFACTURER
Medtronic Neurological, Minneapolis, MN, by a product Hold Order issued August 2, 2006. Firm initiated recall is ongoing.
REASON
Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
VOLUME OF PRODUCT IN COMMERCE
22 kits
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1538-06;

b) Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1539-06;

c) Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1540-06;

d) Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1541-06
CODE
a) Single Pack - Outer Box UPN H7493893101J0, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 854993/8506164; 8553464/8506163; 8558452/8506162; 8580516/8418120; 8581252/8414121; 8601289/8567104; 8601977/7567103; 8611497/8390776; 8618382/8414119; 8625209/8525244; 8630091/8602645; 8630092/8599793; 8637044/8599796; 8639684/8602647; 8642791/8599795; 8643583/8616749; 8645466/8616759; 8646331/8616971; 8650221/8599794; 8656280/8616970; 8656289/8612088; 8662274/8599797; 8662896/8616760; 8666532/8632041; 8668106/8602646; 8669915/8642147; 8681003/8641004; 8684067/89641006; 8694117/8642148; 8697663/8525245; 8699505/8642146; 8709594/8519073; 8749798/8713578; 8752423/8695650; 8761674/8721471; 8762199/8721350; 8774436/8742235; 8782981/8755555; 8783262/8742236; 8784950/8739386; 8795581/8755557; 8797321/8757433. 5-pack - Outer Box UPN H7493893101J2, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8553465/8506163; 8558453/8506162; 8642073/8607723; 8642792/8599795; 8643584/8616749; 8645467/8616759; 8646332/8616971; 8646667/8607724; 8650220/8599794; 8654220/8612089; 8656281/8616970; 8656290/8612088; 8662275/8599797; 8667578/8641003; 8668107/8602646; 8669916/8642147; 8677642/8519074; 8681004/8641004; 8683824/8530667; 8696525/8642150; 8697664/8525245; 8699506/8642146; 8776585/8739387;

b) Single Pack - Outer Box UPN H7492893102J0, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616992/8498451; 8634476/8576268; 8637834/8592512; 8642641/8542687; 8687373/8644753; 8687380/8620072; 8693389/8644751. 5-pack - Outer Box UPN H7493893102J2, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616993/8498451; 8619932/8428652; 8634477/8576268; 8637835/8592512; 8642642/8542687; 8687374/8644753; 8687381/8620072; 8693471/8644751; 8745684/8677736;

c) Single Pack - Outer Box UPN H7493893103J0, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447584/8424370; 8541995/8510188; 8544020/8510187; 8577183/8503242; 8577293/8503244; 8577534/8333665; 8579728/8418259; 8580421/8406879; 8580887/8475378; 8580917/8475377; 8581079/8530796; 8585386/8503269; 8587755/8503243; 8588197/8503270; 8588877/8388791; 8591438/8376779; 8592293/8418258; 8592533/8414114; 8593589/8559710; 8593596/8539572; 8594060/8559712; 8597428/8539574; 8597830/8556834; 8598870/8388789; 8600066/8559711; 8600420/8564504; 8602812/8564506; 8603659/8567100; 8606749/8389080; 8606923/8567101; 8607935/8579186; 8607935/8556836; 8608015/8579186; 8614864/8580832; 8614869/8424371; 8615879/8567099; 8616669/8539573; 8620583/8596274; 8620754/8475382; 8628574/8596276; 8628912/8580831; 8630440/8596275; 8636284/8602641; 8636415/8602640; 8649768/8607727; 8650600/8602642; 8652901/8607728; 8654225/8602643; 8654227/8607725; 8670952/8530791; 8676700/8635975; 8685522/8649203; 8690104/8635973; 8698011/8635340; 8698012/8635972; 8698293/8653545; 8699510/8635341; 8699989/8530668; 8701815/8635976; 8702228/8530797; 8710305/8556838; 8711647/8649204; 8711691/8653546; 8711815/8661235; 8712096/8665816; 8712099/8530790; 8716342/8653547; 8722177/8683665; 8722191/8693297; 8722301/8665815; 8730052/8665814; 8731234/8695647; 8733364/8683670; 8734071/8691635; 8740494/8687514; 8741462/8661234; 8745691/8687516; 8748547/8693296; 8749063/8695649; 8750426/8708960; 8753228/8683668; 8754548/8693298; 8758129/8708968; 8758432/8719088; 8759720/8691637; 8764914/8721351; 8766444/8721352; 8766905/8708969; 8769690/8718984; 8769944/8695646; 8773040/8708966; 8773153/8691639; 8775975/8719089; 8776994/8744947; 8783863/8708965; 8784103/8708958; 8784392/8756635; 8785597/8756634; 8788048/8687515; 8789999/8760871; 8793576/8743903; 8794952/8767167; 8797558/8744946; 8798246/8760865; 8800605/8760864; 8801108/8744945. 5-pack - Outer Box UPN H7493893103J2, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447685/8424370; 8541998/8510188; 8544019/8510187; 8577096/8475380; 8577182/8503242; 8577294/8503244; 8577535/8333665; 8580409/8418259; 8580422/8406879; 8580888/8475378; 8580918/8475377; 8581080/8530796; 8592294/8418258; 8592534/8414114; 8593591/8559710; 8593597/8539572; 8594061/8559712; 8597829/8539574; 8597831/8556834; 8598871/8388789; 8600065/8559711; 8602822/8564506; 8603658/8567100; 8606831/8389080; 8606924/8567101; 8607936/8579186; 8607936/8556836; 8608018/8579186; 8614865/8580832; 8615130/8424371; 8615880/8567099; 8616668/8539573; 8617431/8580830; 8620755/8475382; 8630441/8596275; 8636285/8602641; 8636416/8602640; 8640730/8596273; 8649767/8607727; 8650599/8602642; 8652900/8607728; 8654224/8602643; 8654226/8607725; 8676701/8635975; 8677779/8635342; 8698294/8653545; 8699851/8635341; 8699990/8530668; 8701816/8635976; 8702229/8530797; 8711692/8653546; 8711816/8661235; 8712098/8665816; 8712100/8530790; 8716343/8653547; 8722178/8683665; 8722302/8665815; 8722332/8693297; 8731237/8695647; 8733366/8683670; 8734132/8691635; 8740495/8687514; 8741463/8661234; 8748549/8693296; 8749065/8695649; 8750427/8708960; 8753229/8683668; 8754545/8708967; 8754549/8693298; 8758131/8708968; 8758433/8719088; 8759722/8691637; 8764915/8721351; 8766445/8721352; 8773154/8691639; 8774030/8743905; 8775976/8719089; 8776995/8744947; 8779683/8743904; 8783864/8708965; 8784104/8708958; 8784393/8756635; 8785598/8756634; 8788047/8687515; 8793578/8743903; 8794953/8767167; 8797559/8744946; 8798247/8760865; 8800606/8760864; 8801109/8744945;

d) Single Pack - Outer Box UPN H7493893104J0, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578445/8498450; 8615997/8579187; 8616986/8428651; 8625889/8542669; 8634387/8592510; 8661236/8615192; 8676306/8623927; 8679477/8614968; 8684638/8614969; 8691987/8614967; 8711404/8615194; 8711707/8640992; 8716167/8615190; 8775301/8721349. 5-Pack - Outer Box UPN H7493893104J2, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578446/8498450; 8615998/8579187; 8616987/8428651; 8625890/8542669; 8634388/8592510; 8661241/8615192; 8676307/8623927; 8679478/8614968; 8684639/8614969; 8691990/8614967; 8711405/8615194; 8711708/8640992; 8716168/8615190; 8775302/8721349
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, by letter, dated August 31, 2006.
Manufacturer: Boston Scientific Corporation, Miami, FL. Firm initiated recall is ongoing.
REASON
The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
VOLUME OF PRODUCT IN COMMERCE
5,535 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR October 4, 2006

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