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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Community Blood Centers of South Florida, Inc. Class III Terminated Florida Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated California Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Tri-Counties Blood Bank dba UBS- Central Coast Class II Terminated AZ, CA Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Florida Blood Services, Inc. Class II Terminated Florida Details
Biologics ONEBLOOD, Inc. Class III Terminated Florida Details
Biologics American National Red Cross (The) Class II,Class III Terminated Arizona, California Details
Biologics American National Red Cross (The) Class II,Class III Terminated California Details
Biologics American National Red Cross (The) Class II Terminated California Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated New York and Florida. Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated New York Details
Biologics Florida Blood Services, Inc. Class III Terminated Florida Details
Biologics CSL Plasma, Inc. Class III Terminated IL, Germany, Switzerland Details
Biologics Talecris Plasma Resources, Inc. Class III Terminated North Carolina Details
Biologics Delta Blood Bank Class II Terminated Austria Details
Devices St. Jude Medical Class II Ongoing Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom. Details
Drugs Mobius Therapeutics LLC Class I Ongoing Nationwide and Military and Government Consignees Details
Veterinary Kasel Associates Industries, Inc. Class I Ongoing Nationwide distribution. Details
Veterinary Honest Kitchen Class I Ongoing Nationwide in the US and in Canada. Details
Veterinary Central Garden Pet Company Class I Ongoing Nationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates. Details
Veterinary Jones Natural Chews, Co., Inc. Class I Ongoing AZ, CA, CO, PA, VA, and WI Details
Drugs Med Prep Consulting, Inc. Class I,Class II Ongoing Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA Details
Food Whole Foods Market Class II Ongoing Nationwide Details
Biologics HCSC-Blood Center Class II,Class III Terminated Pennsylvania; Korea, Details
Food Green Mountain Coffee Roasters Class II Ongoing TX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL Details
Biologics Hoxworth Blood Center UC Medical Center Class II Terminated Ohio Details
Biologics Florida's Blood Centers - Lake Park Class II Terminated Florida Details
Biologics Biotest Pharmaceuticals Corporation Class II Terminated Korea, Republic Of(South) Details
Biologics Northern California Community Blood Bank Class II Terminated California Details
Drugs Alkermes, Inc. Class II Ongoing Nationwide Details
Biologics Blood Systems, Inc Class II Terminated Montana Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics Talecris Plasma Resources Inc Class III Terminated North Carolina Details
Biologics Northern Illinois Blood Bank dba Rock River Valley BC Class II Terminated Indiana Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN. Details
Biologics Tacoma Pierce County Blood Bank Class II Terminated Washington Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics American National Red Cross The Class II Terminated California Details
Biologics Mississippi Blood Services Inc. Class III Terminated Tennessee Details
Biologics LifeServe Blood Center Class II Terminated New Jersey Details
Biologics Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc Class II Terminated Texas Details
Biologics Community Blood Center Class III Terminated Indiana Details
Drugs Pharmalucence, Inc. Class III Ongoing Nationwide & Bahamas, Barbados, Bermuda, Japan Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Canada, Columbia, Nigeria, Kuwait and Saudi Arabia. Details
Devices Advanced Orthogonal Equipment, Incorporated Class II Ongoing Nationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA. Details
Devices Instrumentation Laboratory Co. Class II Ongoing Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kossovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan. Details
Devices Etac Supply Center Ab Class II Ongoing International distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates. Details
Drugs West-Ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Food American Importing Co, Inc Class II Ongoing IL, IN, IA, KS, MN, NJ, NY, NC, OH, SC, TX, VT. Details
Biologics Blood Bank Computer Systems, Inc Class II Ongoing Nationwide Details
Biologics BD Biosciences, Systems & Reagents Class II Ongoing Worldwide distribution. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) 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 NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA 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, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM and YEMEN. Details
Devices National Biological Corp Class III Ongoing Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico. Details
Devices National Biological Corp Class III Ongoing US distribution including the states of: AL, CA, MN, and NC. Details
Drugs Astellas Pharma US Inc Class II Ongoing Nationwide and Canada Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela. Details
Drugs Watson Laboratories, Inc.-(Actavis) - Florida Class II Ongoing Nationwide Details
Devices Myoscience Inc Class II Completed US distribution including CA and ID. Details
Food Bergin Fruit And Nut Co Inc Class I Ongoing CA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI. Details
Devices LeMaitre Vascular, Inc. Class I Ongoing Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY. Details
Drugs Gilead Sciences, Inc. Class II Ongoing Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden. Details
Food Price Chopper Golub Corperisable Warehouse Class II Ongoing Price Chopper stores in NY, NH, MA, VT, PA and CT. Details
Devices Physio Control, Inc. Class II Ongoing Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada. Details
Devices Steris Corporation Class II Ongoing USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada. Details
Devices GE Healthcare, LLC Class I Ongoing Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam. Details
Devices Medtronic Neurosurgery Class II Ongoing Nationwide Distribution in the US. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution. Details
Devices Becton Dickinson & Co. Class II Ongoing Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan. Details
Drugs Oklahoma Respiratory Care Inc Class II Ongoing Oklahoma Details
Devices Philips Healthcare Inc. Class II Ongoing USA Nationwide Distribution Details
Drugs Max Huber Research Labs, Inc. Class III Ongoing Nationwide Details
Devices Del Mar Reynolds Medical, Ltd. Class II Ongoing Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian. Details
Devices Haemonetics Corporation Class II Ongoing US Nationwide Details
Food NOW Foods Class II Ongoing US: Nationwide; Foreign: United Kingdom Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution and Puerto Rico Details
Devices Stryker Neurovascular Class II Ongoing International Distribution including Austria, China, and Germany. Details
Food C Pacific Food Class III Ongoing TX Details
Devices Pemco Inc Class II Ongoing Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore. Details
Devices Church & Dwight Inc Class II Ongoing Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD. Details
Food Priester Pecan Company, Inc. Class I Ongoing Nationwide and Puerto Rico Details
Devices Topcon Medical Laser Systems, Inc Class II Terminated Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa. Details
Devices Aesculap, Inc. Class II Ongoing US Distribution including the states of NV and MI Details
Food High Quality Organics, Inc. Class I Ongoing CA, FL, NY Details
Food Hearthside Food Solutions LLC Class I Ongoing Nationwide, no OUS distribution Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Guam Details
Drugs Watson Laboratories Inc Class III Ongoing Nationwide Details
Drugs Vi-Jon, Inc. Class III Ongoing Nationwide Details
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