Enforcement Report - Week of June 27, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Devices | App Pharmaceuticals Llc | Class II | Terminated | Nationwide Distribution and Puerto Rico | Details |
| Drugs | Physicians Total Care, Inc | Class I | Completed | FL | Details |
| Devices | American Optisurgical Inc | Class II | Terminated | Nationwide distribution: MN only. | Details |
| Devices | Biomet 3i, LLC | Class II | Ongoing | Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK. | Details |
| Food/Cosmetics | Club Chef LLC | Class I | Ongoing | Product was shipped to the following states: IL, IN, KY, OH, TN & VA. | Details |
| Food/Cosmetics | Pr Supplies Co., Inc. | Class II | Ongoing | Puerto Rico only. | Details |
| Devices | GE Healthcare, LLC | Class I | Completed | Nationwide Distribution-including the states of AL, FL, GA, MO, and VA. | Details |
| Devices | Tripath Imaging, Inc. | Class III | Ongoing | Worldwide Distribution. | Details |
| Devices | Medtronic Navigation, Inc. | Class II | Terminated | Nationwide Distribution including the states of CO, IN, and MN. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam. | Details |
| Drugs | Teva Pharmaceuticals USA, Inc. | Class III | Ongoing | Nationwide | Details |
| Devices | Accumetrics Inc | Class II | Ongoing | US Nationwide Distribution | Details |
| Devices | Nidek Medical Products Inc | Class I | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, and VIETNAM. | Details |
| Food/Cosmetics | Casa De Mesquite Llc | Class II | Ongoing | Product was released for distribution in US and Canada. | Details |
| Devices | Non-Invasive Monitoring Systems, Inc. | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | 6 US customers | Details |
| Drugs | Abbott Laboratories | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Santos Inc. | Class I | Ongoing | Distributed to retail markets in Northern California. | Details |
| Food/Cosmetics | Gills Onions, LLC | Class I | Ongoing | Worldwide to: Canada and nationwide to: retailers and foodservice distributors in California, Oregon, Washington, Arizona, Idaho, Texas, Illinois, Michigan, Arkansas, Ohio, Tennessee, New Jersey, Georgia, and Florida. | Details |
| Devices | Spacelabs Healthcare, Llc | Class II | Ongoing | Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM. | Details |
| Drugs | Linde Gas LLC | Class II | Ongoing | Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product. | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE | Details |
| Devices | Boston Scientific Corporation | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland | Details |
| Food/Cosmetics | LA Link Corporation | Class III | Ongoing | Distributed to retail in the following states: HI, NV, CA | Details |
| Devices | Covidien LP | Class II | Ongoing | Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPAÑA France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK. | Details |
| Devices | Natus Medical Incorporated | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom. | Details |
| Drugs | Kutol Products Co Inc | Class II | Ongoing | IL | Details |
| Food/Cosmetics | Oskri Organics Corp. | Class I | Ongoing | AZ, CA, DE, FL, GA, MD, MI, MN, NJ, NY, NC, OR, TX, UT, VA, WA. | Details |
| Food/Cosmetics | Ocean Group Inc. | Class II | Ongoing | California | Details |
| Food/Cosmetics | Kerry Foods | Class II | Ongoing | AZ, CA, MN, NV, NC, OR, IL, IN, MO, NE, OH, PA, TN, TX, WI. CANADA, CHILE | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom | Details |
| Drugs | Hospira, Inc. | Class III | Ongoing | Nationwide | Details |
| Devices | Ultradent Products, Inc. | Class II | Ongoing | Worldwide Distribution. | Details |
| Devices | Arrow International Inc | Class II | Ongoing | USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI. | Details |
| Devices | Genzyme Corporation | Class II | Ongoing | Worldwide Distribution - US (nationwide) and the country of S. Korea | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide Distribution | Details |
| Drugs | Physicians Total Care, Inc. | Class II | Completed | AK, NC, GA | Details |
| Food/Cosmetics | Woosung America Corp. | Class II | Ongoing | Northern CA only. | Details |
| Food/Cosmetics | Sonora Mills Foods | Class II | Ongoing | US Nationwide and Canada | Details |
| Food/Cosmetics | World Finer Foods, Inc. | Class III | Ongoing | Nationwide | Details |
| Food/Cosmetics | Camerican International | Class III | Ongoing | Nationwide | Details |
| Food/Cosmetics | Indonesian Food Mart | Class I | Ongoing | Product was distributed nationwide and internationally to Australia, Canada, Slovenia, New Zealand, Brunei, Darussalam, Poland and Croatia. | Details |
| Food/Cosmetics | True World Foods San Francisco LLC. | Class II | Ongoing | Restaurants in Northern Ca only. | Details |
| Food/Cosmetics | King Seafoods Inc. | Class III | Ongoing | North Carolina, South Carolina and Tennessee | Details |
| Food/Cosmetics | Red Chamber Company | Class II | Ongoing | California and Floria | Details |
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