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U.S. Department of Health and Human Services

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 Club Chef LLC Class I Ongoing Product was shipped to the following states: IL, IN, KY, OH, TN & VA. Details
Food 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 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 Santos Inc. Class I Ongoing Distributed to retail markets in Northern California. Details
Food 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 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, ESPA√ĎA 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 Oskri Organics Corp. Class I Ongoing AZ, CA, DE, FL, GA, MD, MI, MN, NJ, NY, NC, OR, TX, UT, VA, WA. Details
Food Ocean Group Inc. Class II Ongoing California Details
Food 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 Woosung America Corp. Class II Ongoing Northern CA only. Details
Food Sonora Mills Foods Class II Ongoing US Nationwide and Canada Details
Food World Finer Foods, Inc. Class III Ongoing Nationwide Details
Food Camerican International Class III Ongoing Nationwide Details
Food 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 True World Foods San Francisco LLC. Class II Ongoing Restaurants in Northern Ca only. Details
Food King Seafoods Inc. Class III Ongoing North Carolina, South Carolina and Tennessee Details
Food Red Chamber Company Class II Ongoing California and Floria Details
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