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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices First Medical Source LLC Class I Terminated US Nationwide distribution in the state of IL Details
Drugs XRock Industries, LLC Class I Ongoing Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom. Details
Food Botanical Laboratories Inc Class I Ongoing Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate Details
Devices Progressive Medical Inc Class II Terminated US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI. Details
Drugs Ben Venue Laboratories Inc Class II Ongoing Nationwide and Puerto Rico. Details
Biologics Blood Assurance Inc Class II,Class III Terminated North Carolina; Indiana Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Biologics Central Blood Bank Class II,Class III Terminated Pennsylvania; Florida Details
Drugs Coral Rock Man, Inc. Class I Ongoing Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales. Details
Biologics Blood Assurance Inc Class II,Class III Terminated Tennessee; Georgia; Indiana Details
Biologics LifeSource Class II Terminated Illinois; Pennsylvania; Switzerland Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana Details
Biologics Octapharma Plasma, Inc. Class II Terminated Austria Details
Biologics Suncoast Communities Blood Bank, Inc. Class II Terminated Florida Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated North Carolina; Details
Biologics American National Red Cross, Penn Jersey Region Class II Terminated New Jersey Details
Biologics Northern California Community Blood Bank Class II Terminated California Details
Biologics LifeSouth Community Blood Centers Inc Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers Inc - Birmingham Region Class II Terminated Alabama Details
Biologics Inland Northwest Blood Center Class II Terminated Washington Details
Biologics Suncoast Communities Blood Bank, Inc. Class II Terminated Korea, Republic Of(South); Florida Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Missouri Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington Details
Biologics Talecris Plasma Resources, Inc. Class II Terminated California Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Biologics LifeShare Blood Centers Class II Terminated Switzerland; TX Details
Biologics LifeShare Blood Centers Class II Terminated AR Details
Biologics South Texas Blood & Tissue Center Class II Terminated FL; TX Details
Biologics Blood Systems, Inc. dba United Blood Services Class II Terminated TX Details
Biologics Community Blood Centers of Florida, Inc. Class II Terminated FL Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated FL Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated FL Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Completed Switzerland, MA, FL, NJ and NY Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida; New York Details
Biologics Community Blood Centers of Florida, Inc. Class II,Class III Terminated Switzerland; Florida Details
Food Productos El Gauchito Class II Ongoing Puerto Rico only (hotels, gas stations, restaurants) Details
Devices Maquet Cardiovascular Us Sales, Llc Class II Ongoing US Nationwide Distribution Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Completed Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand Details
Devices Vital Images, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, AND YEMEN Details
Devices Oscor, Inc. Class II Ongoing Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand Details
Devices Heartsine Technologies, Limited Class I Ongoing Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI. Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain. Details
Devices Stryker Spine Class II Ongoing Nationwide distribution. Details
Food Popcorn Indiana LLC Class II Ongoing Nationwide, Canada Details
Food Harry and David Operations, Inc. Class I Ongoing Nationwide and Canada through online ordering www.harryanddavid.com/h/home and through retail stores located throught the U.S. Details
Devices Elekta, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) and country of Canada. Details
Devices Wright Medical Technology Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom. Details
Devices Ventlab Corporation Class I Ongoing Nationwide Distribution including IL, OH, NY and TN. Details
Food Xan Confections Class I Ongoing The recall affected Xan Confections products distributed through 98 stores in California, Arizona, Nevada, Oregon, Washington, Texas, Alabama, Louisiana and Nova Scotia (Canada), as well as through online distribution. Details
Drugs DermaCare, Inc. Class II Ongoing Nationwide Details
Devices Sorin Group USA, Inc. Class II Ongoing Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates. Details
Devices Alphatec Spine, Inc. Class II Ongoing Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT. Details
Devices Focus Diagnostics Inc Class III Ongoing Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan. Details
Food Wild Foods, Inc Class I Ongoing retail stores in WI and Rockford, IL Details
Food Smith Dairy Products Co Class I Ongoing Product was shipped to the following states: IN, MI, OH & WV. Details
Food Dean Foods of California Inc Class I Ongoing California, Idaho, Montana, Nevada, North Dakota, Oregon, Utah, Wyoming, Washington. Details
Food Sunland, Incorporated Class I Ongoing Nationwide, Canada, France. Details
Devices Varian Medical Systems, Inc. Oncology Systems Class II Ongoing Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom. Details
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