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/Cosmetics | 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/Cosmetics | 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/Cosmetics | Popcorn Indiana LLC | Class II | Ongoing | Nationwide, Canada | Details |
| Food/Cosmetics | 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/Cosmetics | 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/Cosmetics | Wild Foods, Inc | Class I | Ongoing | retail stores in WI and Rockford, IL | Details |
| Food/Cosmetics | Smith Dairy Products Co | Class I | Ongoing | Product was shipped to the following states: IN, MI, OH & WV. | Details |
| Food/Cosmetics | Dean Foods of California Inc | Class I | Ongoing | California, Idaho, Montana, Nevada, North Dakota, Oregon, Utah, Wyoming, Washington. | Details |
| Food/Cosmetics | 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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