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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Community Blood Center of Greater Kansas City Class III Terminated Missouri and Kansas Details
Biologics Mary Greeley Medical Center Class II Terminated FL, IA, NY Details
Biologics American Red Cross Blood Services Class II Terminated MO, TN, IL, TX, AR Details
Biologics BioLife Plasma Services LP Class II Terminated IL Details
Biologics American National Red Cross, The Class III Terminated CA Details
Biologics CSL Plasma, Inc Class II Terminated IL, Switzerland & Germany Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri Details
Biologics CSL Plasma, Inc Class II Terminated IL Details
Biologics CSL Plasma, Inc Class II Terminated IL Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri and Illinois Details
Biologics Csl Plasma Inc Class II Terminated Illinois, Switzerland, Germany Details
Biologics CSL Plasma, Inc Class II Terminated IL & Switzerland Details
Biologics CSL Plasma, Inc Class II Terminated IL & Switzerland Details
Biologics CSL Plasma, Inc Class II Terminated IL, Switzerland & Germany Details
Biologics CSL Plasma, Inc Class II Terminated Switzerland Details
Biologics CSL Plasma, Inc Class II Terminated Switzerland Details
Biologics CSL Plasma, Inc Class III Terminated Switzerland Details
Biologics CSL Plasma, Inc Class II Terminated IL & Switzerland Details
Biologics CSL Plasma, Inc Class II Terminated IL & Switzerland Details
Devices Orthohelix Surgical Designs Inc Class II Completed Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI. Details
Biologics American National Red Cross (The) Class II Terminated CA, MA Details
Biologics CSL Plasma, Inc. Class II Terminated IL, Switzerland, Germany Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class II Terminated CA Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics Delta Blood Bank Class II Terminated CA. Details
Biologics MedImmune, LLC Class III Ongoing Product was distributed within the US to CA, FL and TX. Government account: Department of Defense, Camp Pendleton, CA. Details
Food Mothers' Milk Bank at Austin Class III Completed Austin,TX Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa. Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics Octapharma Plasma, Inc. Class II Terminated Austria Details
Biologics Central California Blood Center Class II Terminated California; Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics The American National Red Cross - Southern Region Class II Terminated Georgia Details
Biologics Interstate Blood Bank Inc. of Wisconsin Class II Terminated Germany, Israel Details
Biologics Community Blood Center Class III Terminated Ohio Details
Biologics Sunquest Information Systems, Inc. Class II Terminated Nationwide Details
Drugs Actavis Mid Atlantic LLC Class III Ongoing Nationwide & Puerto Rico Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA. Details
Biologics Greer Laboratories Inc Class II Ongoing CA, IL, IA, NM, TN Details
Devices Immunodiagnostics Systems Ltd Class II Ongoing Nationwide Distribution including NY, CA, ME and CT. Details
Biologics Associates of Cape Cod, Inc. Class III Ongoing CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan Details
Food Pacific Northwest Tofu, LLC Class II Completed Product distributed in Oregon Details
Food Cinnabar Specialty Foods Inc Class II Ongoing Nationwide to following states: MT, CA, AZ, PA, NC, TX, VA, IL, MI, CO, UT, GA, WA, WY, AK, FL, MO, ID. Details
Food Mothers' Milk Bank at Austin Class II Completed TX Details
Devices Biomerieux Inc Class II Ongoing Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada. Details
Biologics Siemens Healthcare Diagnostics Inc. Class II Ongoing Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA. Details
Devices Baxter Healthcare Corp. Class I Ongoing Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. Details
Devices Remington Medical Inc. Class II Ongoing Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX. Details
Biologics Immucor Inc Class II Ongoing Nationwide, Bahrain, Canada, China, Columbia, Germany, South Africa, Ireland, Japan, New Zealand, Norway, Peru, and South Korea Details
Food Manna Organics Inc Class I Ongoing NY, NJ, PA, MA, VA, MD, CT, GA, IL, and TX Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC Details
Devices Winco Mfg., LLC Class II Ongoing Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia Details
Food Spokane Produce, Inc. Class I Ongoing Retail accounts in ID, MT and WA Details
Food Eco Health, Inc. Class I Ongoing Nationwide in the US Details
Devices Kardium Class II Ongoing Nationwide Distribution-including the states of FL, GA, IL, and NH. Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom. Details
Food Forever Cheese Inc Class I Ongoing Nationwide Details
Devices Advanced Neuromodulation Systems Inc. Class II Ongoing US Nationwide Distribution Details
Devices Medtronic Sofamor Danek USA Inc Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. Details
Devices Beckman Coulter Inc. Class II Terminated Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay Details
Food Newark Nut Stores, Inc. Class I Ongoing Nationwide Details
Food Springside Cheese Corp Class II Ongoing WI, CO Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe. Details
Devices Accutron Inc Class I Ongoing US Nationwide Distribution Details
Devices Alere San Diego, Inc. Class II Terminated Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay. Details
Food Chang Jiang Seafood Ca Inc Class III Ongoing AZ, CA, UT Details
Food World Finer Foods, Inc. Class II Ongoing Nationwide Details
Food GM Distributing Co, Inc Class I Ongoing AZ, GA, IL, MN, NY, and TX Details
Food Pepsi Bottling Group Nashville Class II Completed GA, TN, KY, and IN Details
Food United Salad Company Class I Ongoing Distributed to wholesale and retail customers in Alaska, Idaho, Montana, Oregon and Washington Details
Food Cut Fruit Express, Inc. Class I Ongoing MI, MN, WI Details
Devices Optovue Inc. Class II Ongoing Worldwide distribution -- USA (nationwide) and Internationally. Details
Devices 3M Company - Health Care Business Class II Ongoing Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe. Details
Food Kroger Co Class I Ongoing Product was shipped to the following states: AL, GA, IL, IN, KS, KY, MI, MO, NC, NE, OH, SC, TN, VA & WV. Details
Food 3fish Inc. Class I Ongoing NC and SC Details
Food Fresh Express Incorporated Class I Ongoing Initial distribution to: IL, MI, MN, ND, NY, NJ, SD, WI, IA, IN, OH and PA. Waiting for distribution information from firm. Details
Food G.O. Fresh Class I Ongoing Minnesota, Iowa, North Dakota and Wisconsin Details
Drugs Paddock Laboratories, LLC Class II Ongoing Nationwide Details
Devices ICU Medical, Inc. Class II Ongoing Nationwide distribution: Virginia only. Details
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