Enforcement Report - Week of December 12, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | American Red Cross Blood Services | Class II | Terminated | OK, CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | Community Blood Center Of Gtr KC | Class III | Terminated | Kansas; Austria | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | North Carolina | Details |
| Biologics | Talecris Plasma Resources, Inc. | Class II | Terminated | North Carolina | Details |
| Devices | Natus Medical Incorporated | Class I | Ongoing | Worldwide distribution: USA (nationwide) including states of: AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of: Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam. | Details |
| Veterinary | Lloyd Inc | Class II | Ongoing | Distribution was made nationwide. There was no foreign, military, or government distribution. | Details |
| Drugs | Lloyd Inc. of Iowa | Class II | Ongoing | Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution. | Details |
| Veterinary | Lloyd Inc. of Iowa | Class III | Ongoing | Distribution was nationwide. There was no foreign, military, or government distribution. | Details |
| Biologics | LifeNet Health | Class II | Completed | The tissues were shipped nationwide and to Canada and Korea. | Details |
| Food/Cosmetics | Tomales Bay Foods, Inc. | Class I,Class II | Terminated | Part One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece. Part Two: Dates of Distribution: 6/2512 - 7/27/12 Pattern: CA, NC, FL | Details |
| Devices | Merit Medical Systems, Inc. | Class II | Ongoing | Nationwide distribution: US including states of: NE and SD. | Details |
| Biologics | American Natl Red Cross Mid Atlantic Region | Class III | Terminated | California | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | California | Details |
| Biologics | Suncoast Communities Blood Bank, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Michigan Blood | Class II | Terminated | Michigan | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | New York | Details |
| Biologics | LifeServe Blood Center | Class III | Terminated | Switzerland; Iowa | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Florida; Kentucky | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II,Class III | Terminated | Florida; New Zealand | Details |
| Biologics | CaridianBCT, Inc. | Class II | Ongoing | US distribution only: VA, MS, SC, AZ, TN, MI, TX, PN, CA, NY, CA, UT. | Details |
| Drugs | Genentech Inc | Class II | Ongoing | Nationwide | Details |
| Biologics | BloodCenter of Wisconsin, Inc | Class II | Terminated | Wisconsin | 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 | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia,United Arab Emirates (UAE), Singapore, USA, Malaysia, BELGIUM, Japan, and CANADA. | Details |
| Food/Cosmetics | Breedlove Foods, Inc. | Class I | Ongoing | Product was exported to Columbia. | Details |
| Biologics | LifeNet Health | Class II | Terminated | New York | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class II | Ongoing | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY | Details |
| Biologics | Northern Illinois Blood Bank dba Rock River Valley BC | Class II | Terminated | Illinois | Details |
| Biologics | Knoxville Plasma Corporation | Class III | Terminated | California | Details |
| Biologics | Our Lady Of The Lake Hospital Inc | Class II | Terminated | Louisiana | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Worldwide Distribution. | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI. | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Ongoing | Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI. | Details |
| Drugs | Ferring Pharmaceuticals Inc | Class III | Ongoing | nationwide | Details |
| Devices | Philips And Neusoft Medical Systems Co., Ltd. | Class II | Ongoing | Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico. | Details |
| Biologics | Transplant Services Center UT Southwestern Medical Center | Class III | Terminated | Texas | Details |
| Devices | Roche Diagnostics Operations, Inc. | Class II | Ongoing | Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI. | Details |
| Devices | Sekisui Diagnostics Llc | Class II | Ongoing | Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA. | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Eastonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Lybia, Malta, Mexico, Netherlands, New Zealnd, Norway, Oman, Polnad, Protugual, Quatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Soth Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK. | Details |
| Drugs | Caraco Pharmaceutical Laboratories, Ltd. | Class II | Ongoing | Nationwide | Details |
| Devices | Stryker Instruments Div. of Stryker Corporation | Class II | Completed | Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan. | Details |
| Food/Cosmetics | Zingerman's Bakehouse, Inc. | Class II | Ongoing | Michigan and Ohio | Details |
| Devices | OmniGuide, Inc. | Class II | Ongoing | Nationwide Distribution including AZ, FL, MA, NY, OH, and OR. | Details |
| Devices | Invivo Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden. | Details |
| Devices | iwalk inc | Class II | Completed | Nationwide Distribution including OH, NC, and NY. | Details |
| Food/Cosmetics | HP Hood LLC | Class III | Ongoing | Connecticut, Georgia, Florida, Massachusetts, New Jersey, New York, Rhode Island and Wisconsin | Details |
| Food/Cosmetics | Omya Inc | Class I | Ongoing | Nationwide in the US: TX, MN, CA, LA, IL, AZ and Worldwide to Mexico. | Details |
| Biologics | East Tennessee Lions Eye Bank | Class III | Terminated | Tennessee | Details |
| Drugs | Taro Pharmaceuticals U.S.A., Inc. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | Biomet, Inc. | Class II | Ongoing | USA Nationwide Distribution in the state of WI. | Details |
| Food/Cosmetics | Kennys Farmhouse Cheese | Class I | Ongoing | KY, AL, IN, NC, TN, and VA | Details |
| Food/Cosmetics | Boulder Ice Cream | Class I | Ongoing | United States distribution including CT, NJ, NY, GA, NC, SC, AL, TN, ME, MA, RI, LA, TX, AK, OK, CA, AZ, NV, HI, OR, WA, CO, KS, NM, UT. | Details |
| Food/Cosmetics | Hillshire Brands Company | Class I | Ongoing | Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia and Wisconsin. | Details |
| Food/Cosmetics | Beachside Produce Llc | Class II | Terminated | CA and NJ | Details |
| Food/Cosmetics | Legendary Baking | Class I | Ongoing | Distributed to Quality Food Centers (QFC) in Washington State and Oregon by common carrier. | Details |
| Food/Cosmetics | Jagpreet Enterprises Inc. | Class I | Ongoing | IN, CA, TX, MN, GA, CO, WA | Details |
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