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U.S. Department of Health and Human Services

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 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 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 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 HP Hood LLC Class III Ongoing Connecticut, Georgia, Florida, Massachusetts, New Jersey, New York, Rhode Island and Wisconsin Details
Food 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 Kennys Farmhouse Cheese Class I Ongoing KY, AL, IN, NC, TN, and VA Details
Food 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 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 Beachside Produce Llc Class II Terminated CA and NJ Details
Food Legendary Baking Class I Ongoing Distributed to Quality Food Centers (QFC) in Washington State and Oregon by common carrier. Details
Food Jagpreet Enterprises Inc. Class I Ongoing IN, CA, TX, MN, GA, CO, WA Details
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