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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Food Evergreen Orchard Farm, LLC Class II Terminated New Jersey, New York, Virginia and Maryland. Details
Food N4h Research Llc Class II Ongoing The product is distributed in Texas Details
Devices Ge Healthcare It Class II Ongoing US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI. Details
Veterinary Rural King Supply, Inc. Class I Ongoing Nationwide (IL, IN, KY, MI, MO, OH, TN) Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide Distribution: USA (nationwide) and internationally to Canada Details
Food Townsend Farms Inc Class I Ongoing Product was distributed from Townsend Farms to consignees' distribution centers in Arizona, California, North Carolina, Utah, and Washington. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide Distribution: USA (nationwide) and iinternationally to Canada. Details
Drugs Main Street Family Pharmacy, LLC Class I,Class II Ongoing nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Details
Food Scenic Fruit Co Class I Ongoing Product was directly distributed to distribution centers in California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New Hampshire, Pennsylvania, Rhode Island, Texas, and Washington. Details
Food Ocean State Jobbers, Inc. Class II Ongoing Rhode Island, Massachusetts, Connecticut, New Hampshire, Vermont and Maine, New York Details
Veterinary Steve's Real Foods Class I Ongoing Nationwide. Details
Biologics Bio-Rad Medical Diagnostics GmbH Class III Terminated Multiple U.S. States Details
Biologics San Diego Blood Bank Class III Terminated California Details
Biologics American Red Cross Blood Services Tennessee Valley Region Class II Terminated Tennessee Details
Biologics Atlanta Blood Services Class II Terminated Georgia Details
Biologics University Of Miami Miller School of Medicine Tissue Bank Class II Terminated Indiana Details
Biologics Blood Systems, Inc Class II Completed North Dakota; California Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana Details
Biologics Blood Systems, Inc. Class II Terminated Nevada Details
Biologics Blood Systems Inc Class III Terminated Arizona Details
Biologics Blood Systems Inc Class III Terminated Arizona Details
Biologics Blood Systems Inc Class II Terminated Louisiana Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics Michigan Blood Class III Terminated Michigan Details
Biologics OneBlood, Inc. Class II Terminated Florida, New York Details
Biologics Fenwal Inc Class III Ongoing Nationwide and Canada Details
Biologics Haemonetics Software Solutions Class II Ongoing Product was distributed to 34 consignees throughout the US and Puerto Rico, as well as to Saudi Arabia. Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Coffee Memorial Blood Center Class II,Class III Terminated Tennessee; New Jersey Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics The Blood Alliance, Inc. Class II Terminated Florida Details
Biologics Blood Systems, Inc. Class II Terminated Nevada; California Details
Biologics American Natl Red Cross Mid Atlantic Region Class II Terminated Virginia Details
Biologics Plasma Biological Services Inc Class II Terminated California Details
Biologics Talecris Plasma Resources Inc Class II Terminated North Carolina Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Biologics Central Blood Bank Class II Terminated Pennsylvania Details
Devices Smith & Nephew Inc Class II Ongoing Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom. Details
Drugs W.S. Badger Company Inc. Class II Ongoing Nationwide and Canada, Greece, Singapore, Thailand, Norway, American Samoa. Details
Food Borinquen Natural Class II Ongoing PR only. Details
Biologics St Mary's Hospital and Medical Center, Inc. Class III Terminated Colorado Details
Biologics St Mary's Hospital and Medical Center, Inc. Class III Terminated Colorado Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas Details
Biologics Community Blood Bank of Erie County Class II Terminated Pennsylvania Details
Biologics Central Pennsylvania Blood Bank Class II Terminated Pennsylvania Details
Biologics Mississippi Valley Reg Bld Ctr Class III Terminated Iowa Details
Biologics American National Red Cross (The) Class II Terminated Idaho, Utah Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics BloodCenter of Wisconsin, Inc Class III Terminated Wisconsin Details
Biologics Arup Laboratories, Inc. Class II Terminated Utah Details
Devices Olympus America Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT. Details
Drugs Hospira, Inc. Class II Ongoing Nationwide Details
Food Gold Medal Products Class II Ongoing The affected product was distributed in the following states: AK, AR, AZ, CA, CT, GA, IA, ID, IN, MA, MT, PA, TX & WI. The affected product was also distributed to Canada. Details
Drugs American Health Packaging Class II Ongoing Nationwide Details
Food D. F. Stauffer Biscuit Co, Inc. Class I Ongoing Product was distributed directly to one distributor (McLane) who then further distributed to Target department stores located nationwide. Details
Veterinary Lloyd Inc. of Iowa Class III Ongoing Distribution was made in the US to AL, AZ, CA, CO, FL, GA, HI ,IA, ID, IN KS, MI, MN, MO, MS, NC, NY, PA, TX, VA, WA and WI. No foreign distribution was made. Details
Devices Advanced Sterilization Products Class III Ongoing Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution - only AZ . Details
Food Boston Salads & Provisions Co., Inc. Class I Ongoing CT, MA, ME,RI,VT, Details
Food Oma's Choice Inc Class II Ongoing The firm distributes these products in Texas. Details
Devices Cincinnati Sub-Zero Products Inc Class II Ongoing Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom. Details
Food The Sweetwater Co., Inc. Class II Ongoing distributed in CA and OR. Details
Food Garden-Fresh Foods, Inc. Class I,Class II Ongoing CA, IL, IN, MA, MI,MN, MO, OH, PA, WI. Details
Devices Philips Medical Systems, Inc. Class II Ongoing Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand. Details
Food Simply D'Lish, LLC Class II Ongoing US: IL, WI Details
Devices Abbott Point Of Care Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom, Details
Devices CareFusion 303, Inc. Class II Ongoing Nationwide Distribution. Details
Devices CareFusion 303, Inc. Class II Ongoing US Distribution in CA, WY, OH, UT, and MA. Details
Devices Varian Medical Systems, Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe. Details
Veterinary BioMatrix, Inc. Class II Ongoing IA Details
Devices Boston Scientific Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands. Details
Food Allergy Research Group Class II Ongoing IL, FL. GA, NV, NY, CA, NH, AZ and Switzerland and New Zealand Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution: US (nationwide) and to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Luxembourg, Mexico, Monaco, Netherlands, Norway, Romania. Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. Details
Food Crunch Pak, LLC Class I Ongoing products distributed in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MO, MS, NE, NM, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI, and WY. Details
Devices Sunrise Medical (US) LLC Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China. Details
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