Enforcement Report - Week of August 1, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Food/Cosmetics | Pacific American Fish Co Inc | Class II | Ongoing | Nationwide in the US | Details |
| Food/Cosmetics | Atlapac Trading Company Inc | Class III | Ongoing | Distributed to US states. | Details |
| Devices | GE OEC Medical Systems, Inc | Class I | Ongoing | Worldwide distribution. | Details |
| Food/Cosmetics | Meiko Food Company Inc | Class II | Ongoing | Retail supermarket in CA. | Details |
| Food/Cosmetics | Arctic Zero, Inc. | Class I | Ongoing | Nationwide in US | Details |
| Food/Cosmetics | Namias dba Chonita Foods | Class II | Terminated | Distributed solely to one customer in AZ. AZ only. | Details |
| Devices | Mallinckrodt Inc | Class II | Completed | Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALIA, BELGIUM, BRAZIL, CANADA, JAPAN & SINGAPORE. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Biologics | LifeSouth Community Blood Centers Inc | Class III | Terminated | AL | Details |
| Biologics | Blood Systems Inc | Class II | Terminated | LA | Details |
| Biologics | American National Red Cross The | Class II | Terminated | CA | Details |
| Biologics | American National Red Cross (the) | Class II | Terminated | NC | Details |
| Biologics | Interstate Blood Bank, Inc. of Wisconsin | Class II | Terminated | CA | Details |
| Biologics | Community Blood Center of Carolinas | Class II,Class III | Terminated | NC and FL | Details |
| Biologics | Community Blood Center of the Ozarks | Class II | Terminated | MO | Details |
| Biologics | Community Blood Center, Inc. | Class II | Terminated | Switzerland; WI | Details |
| Biologics | American National Red Cross, Greater Ozark-Arkansas Region | Class III | Terminated | AR | Details |
| Biologics | American National Red Cross | Class III | Terminated | CA | Details |
| Biologics | Community Blood Center of the Ozarks | Class II | Terminated | MO | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class III | Terminated | NC | Details |
| Food/Cosmetics | Duane Reade Inc | Class II | Ongoing | New York, New Jersey | Details |
| Drugs | Grandpa Brands Co | Class II | Ongoing | Nationwide | Details |
| Biologics | Blood Assurance Inc | Class II | Terminated | Tennessee | Details |
| Biologics | Blood Bank Of Hawaii | Class II,Class III | Terminated | Hawaii; Austria | Details |
| Biologics | Atlanta Blood Services | Class II | Terminated | Georgia | Details |
| Devices | Ortho-Clinical Diagnostics | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal. | Details |
| Biologics | Inland Northwest Blood Center | Class II | Terminated | Arizona | Details |
| Biologics | American National Red Cross (the) | Class II,Class III | Terminated | North Carolina and California | Details |
| Biologics | Community Blood Center | Class II | Terminated | Ohio | Details |
| Biologics | Community Blood Bank of Erie County | Class II,Class III | Terminated | Pennsylvania; Indiana | Details |
| Biologics | South Texas Blood & Tissue Center | Class II | Terminated | Texas | Details |
| Biologics | The American National Red Cross - Southern Region | Class III | Terminated | California | Details |
| Biologics | Hoxworth Blood Center UC Medical Center | Class II | Terminated | Ohio | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | LifeShare Community Blood Services | Class II | Terminated | Ohio | Details |
| Devices | Exactech, Inc. | Class II | Completed | Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain. | Details |
| Biologics | LifeSource | Class II | Terminated | Illinois | Details |
| Devices | Getinge USA Inc | Class II | Ongoing | Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada | Details |
| Devices | CareFusion 303, Inc. | Class I | Ongoing | US Nationwide Distribution | Details |
| Food/Cosmetics | B & F, Inc., dba Hanmi, Inc | Class II | Ongoing | Products were directly distributed in Alaska, Oregon and Washington. | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | California | Details |
| Biologics | Arc Blood Services, New England Region | Class III | Terminated | Missouri; California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Food/Cosmetics | S Bertram Inc. | Class II | Ongoing | Tri-state area of New Jersey, New York and Pennsylvania. | Details |
| Devices | Leica Microsystems, Inc. | Class II | Ongoing | Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada. | Details |
| Devices | Tripath Imaging, Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia). | Details |
| Drugs | Fougera Pharmaceuticals, Inc. | Class III | Ongoing | Nationwide. | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | Ohio | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Food/Cosmetics | Clorox Co (The) | Class II | Ongoing | Michigan | Details |
| Food/Cosmetics | Kettle Foods, Inc. | Class II | Ongoing | 36 customers Worldwide | Details |
| Food/Cosmetics | Hamchorom Inc. | Class II | Terminated | CA | Details |
| Devices | Synthes USA HQ, Inc. | Class II | Ongoing | Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA. | Details |
| Devices | Synthes USA HQ, Inc. | Class II | Ongoing | Nationwide Distribution including GA, PA, SC, TX, and UT. | Details |
| Devices | The Anspach Effort, Inc. | Class II | Ongoing | US Nationwide Distribution including the states of: Arizona. and California. | Details |
| Devices | OrthoPediatrics Corp | Class II | Ongoing | Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia. | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Worldwide Distribution | Details |
| Devices | GE OEC Medical Systems, Inc | Class I | Completed | Worldwide Distribution | Details |
| Devices | GE OEC Medical Systems, Inc | Class I | Completed | Worldwide Distribution - US Nationwide | Details |
| Devices | Respironics, Inc. | Class I | Ongoing | Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain. | Details |
| Food/Cosmetics | East Bay Seafood Co., Inc. | Class II | Completed | IL, MA, NY, RI | Details |
| Food/Cosmetics | Plenus Group Inc. | Class II | Ongoing | Connecticut, Massachusetts, Maine and Rhode Island | Details |
| Devices | Beekley Corporation | Class II | Ongoing | International Distribution including Nationwide(USA), and the countries of Japan and Canada. | Details |
| Devices | Bridgepoint Medical | Class II | Ongoing | Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden. | Details |
| Devices | Hill-Rom, Inc. | Class II | Ongoing | Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI. | Details |
| Food/Cosmetics | 21st Century Foods, Inc. | Class II | Terminated | CT and MA | Details |
| Devices | Philips And Neusoft Medical Systems Co., Ltd. | Class II | Ongoing | Nationwide Distribution -- North Carolina, Ohio, and Texas. | Details |
| Food/Cosmetics | Cass Clay Creamery AMPI Fargo Division | Class I | Ongoing | MN, WI, ND and IA | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea. | Details |
| Devices | Westone Laboratories, Inc. | Class II | Ongoing | Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom. | Details |
| Devices | AGFA Corp. | Class II | Ongoing | Nationwide Distribution including IN, SC, OH, TX | Details |
| Food/Cosmetics | Southern Bakeries, LLC | Class II | Ongoing | AL, GA, MS, TN, TX, and WI. | Details |
| Devices | Hospira Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada. | Details |
| Food/Cosmetics | Hanmi Incorporated | Class II | Ongoing | The products were distributed to VA, MD, and PA | Details |
| Food/Cosmetics | Wellements, LLC | Class I | Ongoing | Nationwide and Canada | Details |
| Drugs | Stat Rx USA | Class III | Ongoing | Nationwide | Details |
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