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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Drugs Zi Xiu Tang Success, LLC Class I Ongoing Nationwide and Canada to distributors and consumers. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. Details
Devices Remel Inc Class II Completed Nationwide Distribution Details
Devices Remel Inc Class II Completed Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan. Details
Veterinary Pet Brands Inc Class II Ongoing Product was shipped to the following states: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI & WV. Details
Veterinary Hubbard Feeds, Inc. Class I Ongoing Michigan and Indiana Details
Devices Remel Inc Class III Completed Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico. Details
Drugs Healthy Life Chemistry Inc dba Purity First Class I Ongoing Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com). Details
Veterinary Dogswell Llc Class III Ongoing This product was distributed within the contiguous 48 states. Details
Drugs Bethel Nutritional Consulting, Inc Class I Ongoing Nationwide, Puerto Rico, and internet sales Details
Devices mobility unlimited inc Class II Ongoing Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, FL, GA, IL, MN, MO, NY, PA, TN, TX, VA, and Canada. Details
Veterinary Land O Lakes Purina LLC Class I Completed Product was sold to one customer in PA. Details
Drugs Fabscout Entertainment, Inc Class I Ongoing CA, FL and UT Details
Drugs Altaire Pharmaceuticals, Inc. Class I Ongoing Nationwide Details
Drugs Tween Brands Inc Class III Ongoing Nationwide Details
Drugs Hospira Inc. Class I Ongoing Nationwide Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway. Details
Food Turkey Hill Dairy, Inc. Class II Ongoing MA, MD, PA Details
Devices Ortho-Clinical Diagnostics Class II Ongoing Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam. Details
Devices Aesculap, Inc. Class II Ongoing Distributed in FL and MD. Details
Biologics Blood Center of Northcentral Wisconsin, Inc. Class III Terminated WI Details
Biologics Blood Systems, Inc Class III Terminated NM Details
Biologics Upstate New York Transplant Services Class II Terminated NY Details
Devices Arrow International Inc Class II Ongoing Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore. Details
Biologics Arc Blood Services, New England Region Class II Terminated NY, MA Details
Biologics CSL Plasma Class II Terminated IL Details
Biologics Penrose-St Francis Health Services Blood Bank Class II Terminated CO Details
Biologics OneBlood, Inc. Class II Terminated FL, NY Details
Biologics OneBlood, Inc. Class II Terminated FL Details
Biologics Blood Bank Of San Bernardino And Riverside Counties Class II Terminated CA Details
Biologics Aurora Area Blood Bank Dba Heartland Blood Centers Class II Terminated IL Details
Biologics The Blood Connection, Inc. Class II Terminated KY Details
Food Lsg Food World Inc Class II Ongoing NY Details
Devices Microgenics Corp Class II Ongoing Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany. Details
Devices GE Healthcare, LLC Class I Ongoing Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela. Details
Biologics Southern California Permanente Medical Group Blood Donor Ctr Class II Terminated CA Details
Biologics Community Blood Center, Inc. Class II Terminated WI Details
Biologics American National Red Cross Class III Terminated MI, OH Details
Biologics Blood Systems, Inc Class II Terminated NM Details
Biologics OneBlood, Inc. Class II Terminated FL Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics OneBlood, Inc. Class II,Class III Terminated Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida, New York Details
Biologics OneBlood, Inc. Class II,Class III Terminated Switzerland, Florida Details
Food National Enzyme Co Class II Ongoing Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Details
Biologics Blood Systems Inc Class II Terminated Arizona Details
Food Flanes Lymar Class I Ongoing Puerto Rico only. Details
Devices SpineFrontier, Inc. Class II Ongoing US Distribution to VA and TX. Details
Food Taylor Farms Illinois Inc Class II Ongoing IL Details
Food Taylor Farms Tennessee, Inc. Class II Ongoing AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO Details
Food DUTCH TREAT SALADS, INC Class I Ongoing 74 - 14 oz cups 16 - 5lb bags 75 - 10lb cs (2-5lb bags/cs) Details
Devices Nephros Inc Class I Ongoing USA Nationwide Distribution Details
Devices Nephros Inc Class I Ongoing Nationwide Distribution Details
Biologics American National Red Cross The Class III Terminated CA Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated GA Details
Biologics Community Blood Center of Carolinas Class III Terminated NC Details
Food Gourmet Express LLC Class I Ongoing Product was shipped to the following states: GA, IL, IN, MI & TN. Details
Food Global Health Laboratories, LLC Class II Ongoing New York Details
Food Global Health Laboratories, LLC Class II Ongoing Arizona Details
Biologics LifeSouth Community Blood Centers Inc Class II Terminated AL Details
Biologics Lifesouth Community Blood Centers - Montgomery Region Class II Terminated AL Details
Biologics DCI Biologicals Hot Springs, Inc Class III Terminated United Kingdom Details
Biologics Joliet Blood Plasma LLC dba Plasma Care, Inc. Class III Terminated Spain Details
Food A&C US Trading LLC Class II Ongoing NY Details
Food Garden-Fresh Foods, Inc. Class I,Class II Ongoing IL, IN, MI, MN, MO, OH, PA, WI. Details
Drugs Baxter Healthcare Corp. Class II Ongoing Nationwide Details
Devices Qualigen Inc Class II Ongoing US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. Details
Devices CooperVision Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad. Details
Devices Kimberly-Clark Corporation Class II Ongoing U.S. Nationwide Distribution Details
Devices Karl Storz Endoscopy America Inc Class II Ongoing Nationwide Distribution. Details
Food Balajee Trade Link LLC Class II Ongoing AZ, KY, IA, MO, NY, OH, PA, TN, TX, UT, VT Details
Devices Integra LifeSciences Corp. d.b.a. Integra Pain Management Class II Ongoing USA Nationwide Distribution and one foreign consignee in Mursalat. Details
Devices Abbott Diabetes Care, Inc. Class I Ongoing Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User** Details
Food S & M International Inc Class I Ongoing NY Details
Devices Stryker Neurovascular Class II Ongoing Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan Details
Devices Instrumentation Laboratory Co. Class II Ongoing Nationwide Distribution Details
Food Pinnacle Foods, LLC Class II Ongoing NJ, NY, RI, CT, and MA Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia. Details
Drugs Airgas Medical Services Class II Ongoing Kansas, Missouri, and Arkansas. Details
Food 3 Fellers Class I Ongoing Products were distributed in Southern California, Virginia, Maryland, District of Columbia, Delaware, Pennsylvania, New Jersey, Ohio, and Kentucky. Details
Devices 3M Company - Health Care Business Class II Ongoing Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates. Details
Food Threshold Enterprises Ltd Class II Ongoing Nationwide distribution Details
Food Schwabe North America, Inc. Class II Ongoing US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore. Details
Food Flora Inc Class II Ongoing Distributed in the following states: FL, GA, IL, IN, KY, MD, MI, NC, NJ, NV, NY, OH, PA, and SC. Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA. Details
Devices Biomet, Inc. Class II Ongoing hospitals MI, IA, IL, IN, TN Details
Devices Biomet, Inc. Class II Ongoing All product in USA is under Biomet control; Europe, Italy, UK, Australia, Japan Details
Devices ASI Medical, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies. Details
Food Huxtable's Kitchen Inc Class I Ongoing Trader Joe's stores in Southern California, Utah, Southern Nevada and Texas. Details
Devices Smiths Medical ASD, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA. Details
Devices Baxter Corporation Englewood Class II Ongoing Nationwide Distribution Details
Devices GE OEC Medical Systems, Inc Class II Ongoing Nationwide Distribution Details
Drugs West-Ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Food Senor Murphy Candymaker, LLC Class II Ongoing Nationwide. No military/govt/VA or foreign consignees. Details
Drugs Fresenius Kabi USA, LLC Class III Ongoing Nationwide, Puerto Rico, Canada, New Zealand Details
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