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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing US Nationwide and OUS. Details
Drugs Sandoz Incorporated Class II Ongoing Nationwide Details
Devices B. Braun Medical, Inc. Class II Ongoing USA Nationwide Distribution including Puerto Rico. Details
Food Reser's Fine Foods, Inc. Class I,Class II Ongoing Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada. Details
Drugs Amedra Pharmaceuticals LLC Class II Ongoing Nationwide Details
Food Fresh Foods Manufacturing Co. Class II Ongoing MD, OH, PA, WV Details
Drugs Hi-Tech Pharmacal Co., Inc. Class II Ongoing Nationwide Details
Drugs Airgas Medical Services Class II Ongoing To medical facilities in New Hampshire, Vermont, Massachusetts, and New York. Details
Food Taylor Farms Florida, Inc. Class II Ongoing FL Details
Food Taylor Farms Texas, Inc. Class II Ongoing TX Details
Food Taylor Farms Maryland-Assateague Drive Class II Ongoing NY, NJ, PA, MA, MO, MA Details
Devices Siemens Healthcare Diagnostics Class II Ongoing Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela. Details
Devices Data Innovations, Inc. Class II Ongoing Nationwide Canada and Britain Details
Food Vega / Sequel Naturals Class II Ongoing Nationwide. No military/govt/VA. Details
Devices CareFusion 303, Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia. Details
Cosmetics NEW RELIANCE TRADERS, INC. Class II Ongoing CT, PA, MD and RI Details
Food FoodState (Nutrient Manufacturing) Class II Ongoing Nationwide Foreign: Details
Devices SpineFrontier, Inc. Class II Ongoing US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. . Details
Drugs Tower Pharmacy and Compounding Class II Ongoing CA Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Nationwide distribution - all states. Details
Devices SpineFrontier, Inc. Class II Ongoing Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI. Details
Devices Clark Laboratories, Inc. (dba,Trinity Biotech USA) Class II Ongoing USA Nationwide Distribution in the state of WA Details
Food Lewis Bakeries-Evansville Class II Ongoing nationwide Details
Devices C.L.R. Medicals International, Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada. Details
Devices Edwards Lifesciences, LLC Class III Ongoing Distributed to 3 customers in FL only. Details
Devices Materialise USA LLC Class II Completed Distributed in Canada. Details
Devices Integra LifeSciences Corp. d.b.a. Integra Pain Management Class II Ongoing Nationwide Distribution Details
Food Zip International Group LLC. Class I Ongoing NY Details
Devices Varian Medical Systems, Inc. Class II Ongoing Worldwide Distribution. Details
Devices Abbott Vascular, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa. Details
Devices Ziehm Imaging Inc Class II Ongoing USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii. Details
Devices EOS Imaging Class II Ongoing USA Nationwide Distribution Details
Drugs GlaxoSmithKline, LLC. Class II Ongoing Nationwide Details
Food Kettle Cuisine, Inc. Class II Ongoing MD, CT, IL, NY, MA WI Details
Devices OrthoPediatrics Corp Class II Completed Nationwide Distribution including the states of CA, KY, OH, RI, and TN. Details
Drugs Teva Pharmaceuticals USA Class III Ongoing Nationwide and Puerto Rico Details
Devices Mckesson Information Solutions LLC Class II Ongoing MO, NY, TN, WV and France. Details
Devices Smith & Nephew Inc Class II Ongoing Distributed in China and Spain. Details
Devices Philips Medical Systems, Inc. Class II Ongoing US Nationwide and OUS. Details
Veterinary Fresenius Kabi USA, LLC Class III Ongoing US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA. HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; FOREIGN: Canada, New Zealand Details
Food Quaker Foods and Snacks North America Class II Ongoing US: Nationwide (AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, WI, WV, WY) Details
Drugs Physicians Total Care, Inc. Class II Ongoing CA, GA, NC, and MO Details
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