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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Missouri Details
Biologics BioLife Plasma Services L.P. Class II Terminated NC Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated Kansas City, MO; Liberty, MO Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated RI Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas, Missouri Details
Biologics Community Blood Center of Greater Kansas City Class II Terminated RI Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO Details
Biologics American National Red Cross (The) Class II,Class III Terminated California Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated MO, KS Details
Biologics CSL Plasma, Inc Class II Terminated IL Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa; Missouri; Switzerland. Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated California Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Pennsylvania Details
Biologics CSL Plasma, Inc Class II Terminated IL & Switzerland Details
Biologics American National Red Cross (The) Class II Terminated PR and GA Details
Devices Animas Corporation Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom. Details
Devices Stanley Security Solutions, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain. Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. Details
Food Bliss Unlimited Class II Ongoing Canada Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide distribution Details
Devices Eos Imaging Inc Class II Ongoing Nationwide distribution Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA. Details
Drugs Carefusion 213, Llc Class II Completed IL, MO, and NJ Details
Drugs Mylan Pharmaceuticals Inc. Class III Ongoing Nationwide and PR Details
Food J F C International Inc Class I Ongoing Distributed nationwide. No international Details
Devices Invuity, Inc. Class II Ongoing Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA. Details
Food Triple B Corporation Class I Ongoing Product was distributed in Idaho, Montana, and Washington Details
Food Spokane Produce, Inc. Class I Ongoing Washington, Idaho, Montana, Oregon, Wyoming and 9 military bases. Details
Food Oakshire Mushroom Sales, Llc Class I Ongoing Distributed to a single account (Albertson's). Details
Food Cucina Fresca, Inc. Class I Ongoing Product was distributed to Oregon and Washington Details
Food Ocho Rios-Miami, Inc. Class II Ongoing FL, GA, IL, MO, MD Details
Drugs Sun Pharmaceutical Industries Inc. Class II Ongoing One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts Details
Food Sadie's Salads Class I,Class II Ongoing Distribution within the US to PA. Details
Food Taylor Farms, Inc. Class I Ongoing One sole wholesale customer - Wawa Inc., Wawa, PA 19063 Details
Devices Accuro Medical Product LLC Class II Ongoing Worldwide distribution: USA (nationwide) and country of: Canada. Details
Food Pacific Coast Fruit Company Class I Ongoing Distributed to deli retailers in Oregon, Washington, Idaho and Alaska. Details
Devices Biomet, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica. Details
Food Kerry Foods Class I Completed The product was distributed to UT. Details
Food FreshPoint Central California, Inc. Class I Terminated CA only Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM. Details
Food Gills Onions, LLC Class I Ongoing nationwide in the US Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy. Details
Drugs McKesson Packaging Services Class III Completed Nationwide Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden. Details
Devices C.R. Bard, Inc., Urological Division Class II Ongoing Nationwide distribution: USA and Puerto Rico Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and country of: Canada. Details
Food Henderson's Best Fresh-Cuts, LLC Class II Ongoing NC Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,United Arab Emirates and United Kingdom. Details
Food Dfi Marketing Inc Class I Ongoing Nation wide: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Missouri, Nevada, New York, Oklahoma, Tennessee, Texas, Virginia Foreign: Mexico Details
Food Boyd Coffee Co Class II Ongoing Product distributed in Washington Details
Veterinary Kelly Foods Corporation Class II Ongoing Product distributed to AR, DC, DE, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SD, TX, VA, WI, WV. Details
Devices US Endoscopy Group Inc Class II Completed Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates. Details
Devices Cure Medical LLC Class II Ongoing Nationwide Distribution Details
Devices Gynex Corporation Class III Ongoing Nationwide Distribution Details
Food Coast Citrus Dist Class I Ongoing Us states: FL, NY, CO, NJ, KS, PA, AZ, IL, TX, AL, GA, MN, MD, MA, NC, TN, OH, CA, MO, ND, SC, and VA. Details
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