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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics American National Red Cross (The) Class II Terminated KY Details
Biologics Csl Plasma Class II Terminated Germany, Ilinios Details
Biologics Csl Plasma Class II Terminated IL Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics American National Red Cross (The) Class II,Class III Terminated OH, CA Details
Biologics American National Red Cross (The) Class II,Class III Terminated OH, CA Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Central Kentucky Blood Center, Inc. Class II Terminated Kentucky Details
Biologics Tri-counties Blood Bank Class III Terminated California Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class II Terminated CA Details
Biologics American National Red Cross (The) Class II Terminated Poway, California and Escondido, California Details
Biologics American National Red Cross (The) Class II Terminated Ohio Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Presbyterian Intercommunity Hospital, Inc. Blood Bank Class II Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated Products were distributed to a hospital in Akron, OH Details
Biologics American National Red Cross (The) Class II,Class III Terminated OH Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated AZ Details
Biologics American National Red Cross (The) Class II Terminated California, Arizona, Washington DC Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Biologics BioLife Plasma Services L.P. Class III Terminated California Details
Biologics American National Red Cross (The) Class II Terminated Arizona Details
Drugs Chang Kwung Products Class I Ongoing Nationwide Details
Biologics Biomat USA, Inc. Class II Terminated CA, Spain Details
Biologics CSL Plasma, Inc. Class II Terminated IL Details
Biologics Tri-Counties Blood Bank Class III Terminated CA , Austria Details
Biologics Community Blood Center of the Ozarks Class II Terminated MO; TX; AR; NC; TN; OH; MS; Details
Devices Arjo, Inc. dba ArjoHuntleigh Class II Ongoing Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada Details
Drugs Reumofan Plus USA Class I Ongoing Nationwide through internet sales. Details
Devices Ventana Medical Systems Inc Class II Ongoing Worldwide distribution: USA (nationwide) and country of: Germany. Details
Veterinary Steve's Real Food, Inc. Class I Ongoing Distributed to four distributors in CA, TN, RI, and MN. No foreign, government, or military distribution. Details
Biologics Delta Blood Bank Class II Terminated CA, IN Details
Veterinary JDJ Manufacturing, LLC Class I Ongoing directly distributed to California Details
Drugs Hospira Inc. Class I Ongoing Nationwide Details
Devices SpineFrontier, Inc. Class II Ongoing Distribution only in Texas. Details
Devices SpineFrontier, Inc. Class II Ongoing US Distribution including Puerto Rico and the states of CO, KS, MA and TX. Details
Devices SpineFrontier, Inc. Class II Ongoing US Distribution including the states of MA, NV and TX. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Details
Biologics OneBlood, Inc. dba Southeastern Comm. Blood Center Class II Completed Florida; Georgia Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA. Details
Drugs Apotex Corp. Class I Ongoing Nationwide Details
Drugs Sandoz Incorporated Class I Ongoing Nationwide Details
Biologics DCI Donor Services dba Sierra Donor Services Class II Terminated Tennessee Details
Drugs Hospira, Inc. Class II Ongoing Nationwide Details
Devices Becton Dickinson & Company Class II Ongoing Nationwide Distribution Details
Devices Smith & Nephew Inc Class II Ongoing Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom. Details
Drugs Zydus Pharmaceuticals USA Inc Class I Ongoing Nationwide Details
Drugs Novartis Consumer Health Class II Ongoing Nationwide, Puerto Rico, Brazil and Panama Details
Devices SpineFrontier, Inc. Class II Ongoing Nationwide Distribution including Texas, Ohio, and Missouri. Details
Biologics Lifepoint, Inc. Class III Terminated South Carolina Details
Devices Biomerieux Inc Class II Ongoing Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam. Details
Devices Cordis Corporation Class I Ongoing Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, 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, including Hawaii and Puerto Rico and the countries of Canada & Panama Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN. Details
Drugs American Health Packaging Class II Ongoing Nationwide. Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide Details
Drugs AstraZeneca Pharmaceuticals LP Class II Ongoing USA and Puerto Rico Details
Devices CareFusion 303, Inc. Class I Ongoing Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe. Details
Drugs West-Ward Pharmaceutical Corp. Class II Ongoing GA Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL. Details
Devices SpineFrontier, Inc. Class II Ongoing Worldwide Distribution - USA, including the states of CT, VA, FL, TX, CO and MS. and the country of Jamaica. Details
Devices Hospira Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica. Details
Drugs Sanofi US Class II Ongoing Nationwide Details
Food Olde Thompson, Inc. Class I Ongoing US states: " Connecticut " Delaware " Florida " Georgia " Maine " Maryland " Massachusetts " New Hampshire " New Jersey " New York " North Carolina " Ohio " Pennsylvania " Rhode Island " Virginia Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN. Details
Food Golden Beach Inc Class III Completed KY, VA, MS, MO, FL, OH, IN, AL, CA,SC,OK Details
Devices Precision Dynamics Corporation Class II Ongoing US Distribution including the states of SC, TX, TN, WA, OK. Details
Food Aqua Star (USA) Corp. Class II Ongoing Products were directly distributed to NJ and MA and further distributed to PA, NJ, and NY. Details
Devices Medtronic Inc. Cardiac Rhythm Disease Management Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE. Details
Food Olam Tomato Processors, Inc. Class II Ongoing Product sold at Dollar Tree and Deals, Dollar Express and Dollar Bills stores nationwide. Details
Devices Iradimed Corporation Class I Ongoing Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom. Details
Devices Nestle HealthCare Nutrition Class II Ongoing US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA. Details
Devices MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Class II Ongoing Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea. Details
Food Giant Eagle Class II Ongoing Giant Eagle retail stores in 4 states. Details
Drugs West-Ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Devices ASO, LLC Class II Ongoing Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI. Details
Drugs Teva Pharmaceuticals USA, Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Radiometer America Inc Class II Ongoing Worldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, 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, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada. Details
Drugs GlaxoSmithKline, LLC. Class III Ongoing U.S. Nationwide Details
Food Superior Nut Co. Inc. Class I Ongoing Nationwide: AZ, AK, CA, CT, CO, DE, FL,HI, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, ND, NE, NH, NJ, NM, NL, NV, NY, OH, OK, PA, SC, SD, TN,TX, VA, WA, WV, WY Canada Details
Food Primex Intl Trading Corp Class I Ongoing NJ and MA Details
Drugs Sandoz Incorporated Class III Ongoing Nationwide Details
Drugs Actavis Inc Class III Ongoing Nationwide and Puerto Rico Details
Drugs Apotex Inc Class II Ongoing Nationwide Details
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