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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross (The) Class III Terminated New York Details
Biologics LifeServe Blood Center Class II Terminated Iowa Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Center of the Ozarks Class III Terminated Arkansas Details
Biologics Lane Memorial Blood Bank Class II Terminated Oregon, Florida Details
Biologics American National Red Cross Class II Terminated Montana. Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina. Details
Biologics BioLife Plasma Services LP Class III Terminated California Details
Biologics American National Red Cross (The) Class II,Class III Terminated NY Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated North Carolina Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated NC Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated IL, CA Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC, CA Details
Biologics Blood Bank of Alaska, Inc. Class III Terminated New York, Alaska, Louisiana, and Texas. Details
Biologics American National Red Cross Class II,Class III Terminated Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated NC Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated New York Details
Biologics Blood Centers of the Pacific - Irwin Center Class II Terminated California Details
Biologics Blood Centers of the Pacific - Irwin Center Class III Terminated California Details
Biologics Beth Israel Medical Center, The Ralph Gore Blood Bank Class II Terminated New York Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics Florida's Blood Centers, Inc. Class II Terminated Florida Details
Biologics American National Red Cross Class III Terminated California Details
Biologics OneBlood, Inc. Class II,Class III Terminated Swaziland; Florida; New York Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Florida Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated New Zealand; Florida Details
Biologics Blood Assurance Inc Class II Terminated Tennessee; Indiana Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio Details
Biologics BloodCenter of Wisconsin, Inc Class II Terminated Wisconsin Details
Biologics West Tennessee Regional Blood Center Inc Class II Terminated Tennessee Details
Biologics Central Pennsylvania Blood Bank Class II Terminated Pennsylvania Details
Biologics Medic Inc Class II Terminated Tennessee Details
Biologics ITXM Clinical Services Class III Terminated Pennsylvania Details
Food DZH Import & Export Inc. Class I Terminated New York City Details
Food Buffalo Trace Distillery Class I Ongoing Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV. Product was also shipped to Canada and the United Kingdom. Details
Devices Medtronic Neuromodulation Class I Ongoing Worldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam. Details
Drugs Warner Chilcott Company LLC Class III Ongoing US Nationwide and Puerto Rico Details
Devices B. Braun Medical, Inc. Class II Ongoing Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV. Details
Devices Carestream Health, Inc. Class II Ongoing USA Nationwide Distribution Details
Food Nutrex Research, Inc. Class I Ongoing CT, FL, GA, IL, MA, NJ, NV, and TX Details
Devices Discus Dental LLC Class II Terminated Nationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA. Details
Drugs Carib Import & Export, Inc. Class II Ongoing Nationwide, Bahamas, and Turks & Caicos Islands Details
Devices Maquet Cardiovascular Us Sales, Llc Class I Ongoing Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN. Details
Drugs Reckitt Benckiser Inc Class III Ongoing Nationwide Details
Drugs Noven Pharmaceuticals, Inc. Class II Ongoing Nationwide and Puerto Rico. Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Puerto Rico Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Food Rich Products Corp Class I Ongoing Nationwide Details
Devices Masimo Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia. Details
Devices NxStage Medical, Inc. Class II Ongoing Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY. Details
Devices Vital Images, Inc. Class II Ongoing Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN. Details
Devices Hospira Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia. Details
Devices Hospira Inc. Class I Ongoing Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia. Details
Devices Newport Medical Instruments Inc Class I Ongoing Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam. Details
Devices Encore Medical, Lp Class II Ongoing US Distribution to the state of California and International Distribution to the country of Venezuela. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen. Details
Devices Covidien LLC Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa. Details
Drugs Jubilant Cadista Pharmaceuticals Inc. Class II Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM. Details
Food Wegmans Food Markets Class I Ongoing NY, NJ, PA, VA, MD & MA Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom. Details
Devices Owens & Minor Distribution, Inc. Class II Ongoing US Nationwide Distribution. Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa. Details
Food Paleteria Y Neveria La Rosita, LLC Class II,Class III Ongoing Domestic: MI, IN retail stores Details
Veterinary Sandoz Incorporated Class II Ongoing Shipped to one distibutor, Putney Inc in Maine. No foreign, military, or government consignees. Details
Drugs Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals Class II Ongoing Nationwide Details
Devices Advanced Sterilization Products Class II Ongoing Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN. Details
Drugs Physicians Total Care, Inc. Class III Completed FL Details
Drugs Hi-Tech Pharmacal Co., Inc. Class III Ongoing Nationwide and Puerto Rico Details
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