Enforcement Report - Week of July 18, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | American National Red Cross (The) | Class II,Class III | Terminated | Ohio | Details |
| Biologics | Blood Bank of San Bernardino and Riverside Counties | Class II | Terminated | California | Details |
| Biologics | Aultman Hospital Blood Bank | Class III | Terminated | OH | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | OH | Details |
| Biologics | Hoxworth Blood Center University of Cincinnati Medical Center | Class III | Terminated | OH | Details |
| Biologics | Blood Centers of the Pacific | Class III | Terminated | CA | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | IL | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class III | Terminated | CA | Details |
| Biologics | Blood Centers of the Pacific | Class II | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | California | Details |
| Biologics | Hoxworth Blood Center University of Cincinnati Medical Center | Class II | Terminated | IN | Details |
| Food/Cosmetics | Wang Globalnet | Class II | Ongoing | CA, TX, and NM. | Details |
| Food/Cosmetics | Pro Nutech Inc. | Class I | Ongoing | The recalled peanut products were distributed to two (2) customers: Country Oven Bakery, Bowling Green, KY and Smith's Bakery, Layton, UT. | Details |
| Food/Cosmetics | KOREAN FARM, INC. | Class II | Ongoing | Nationwide in the US. | Details |
| Devices | Edwards Lifesciences, LLC | Class II | Ongoing | Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA, Austria | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), and Vietnam. | Details |
| Devices | Advanced Neuromodulation Systems Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to: Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam, | Details |
| Devices | Encision, Inc. | Class II | Ongoing | Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand. | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KENYA, JAPAN, ITALY, IRELAND, INDIA, GREAT BRITAIN, GERMANY, FRANCE, EGYPT, CHILE, CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, and ARGENTINA. | Details |
| Biologics | Community Blood Bank of Lancaster County Medical Society | Class II | Terminated | Florida | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | Nebraska | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | Oregon | Details |
| Biologics | American National Red Cross | Class II,Class III | Terminated | Puerto Rico; California | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Colorado | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Colorado | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Colorado | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Colorado | Details |
| Biologics | New York Blood Center, Inc. | Class II | Terminated | New York | Details |
| Devices | Civco Medical Instruments Inc | Class II | Ongoing | Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. | Details |
| Devices | Atom Medical Corporation | Class II | Ongoing | Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands | Details |
| Veterinary | Solid Gold Hlth Prods For Pets, Inc. | Class I | Ongoing | Distributed to Canada and following US States CA, IL, NY, OH, MI, WA, NV, FL, GA, NJ, PA, AZ, WI, HI, LA, OK, and TX. Canada: 1. Lucid, 5888 Trapp Ave, Burnaby B.C. V3N 5G4 2. 11 Edvac Dr. Units 8 & 9, Brampton, Ontario L6S 5W5 No Mexico. One Foreign: 56 Tannery Ln. Singapore 347801 | Details |
| Biologics | LifeSouth Community Blood Centers, Inc. | Class II | Terminated | Florida | Details |
| Biologics | LifeSouth Community Blood Centers, Inc. | Class II | Terminated | Georgia | Details |
| Biologics | Lifesouth Community Blood Centers, Inc. | Class II | Terminated | Alabama | Details |
| Biologics | LifeSouth Community Blood Centers, Inc. | Class II | Terminated | Georgia | Details |
| Devices | Argon Medical Devices, Inc | Class II | Ongoing | Distributed only in Missouri. | Details |
| Biologics | Community Blood Council of New Jersey, Inc. | Class II | Terminated | New Jersey | Details |
| Biologics | LifeSouth Community Blood Centers, Inc. | Class II | Terminated | Alabama | Details |
| Food/Cosmetics | H & L Jerch Sales, Inc. | Class III | Ongoing | Nationwide | Details |
| Biologics | Medic Inc | Class II | Terminated | Tennessee | Details |
| Biologics | American National Red Cross Great Lakes Region | Class II | Terminated | California | Details |
| Biologics | Central California Blood Center | Class II | Terminated | Maryland | Details |
| Biologics | Central California Blood Center | Class II | Terminated | California | Details |
| Veterinary | Yachere Feed, Inc. | Class II | Ongoing | Direct sales to farms in Fayette and Somerset Counties in PA, 1 direct account located in MD. | Details |
| Biologics | New York Blood Center, Inc. | Class III | Terminated | New York | Details |
| Biologics | Blood Systems, Inc. dba United Blood Services | Class II | Terminated | Texas | Details |
| Biologics | Carter BloodCare | Class II,Class III | Terminated | Switzerland; Texas | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | California | Details |
| Biologics | South Bend Medical Foundation, Inc. | Class II | Terminated | Indiana | Details |
| Biologics | Community Blood Center of Carolinas | Class II | Terminated | North Carolina | Details |
| Biologics | Inland Northwest Blood Center | Class II | Terminated | Florida | Details |
| Biologics | Department of Air Force - BB/HT | Class II | Terminated | Texas | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Alere San Diego, Inc. | Class I | Ongoing | Nationwide Distribution | Details |
| Biologics | Blood Bank Of San Bernardino And Riverside Counties | Class II | Terminated | California | Details |
| Biologics | DCI Biologicals Flagstaff LLC | Class II | Terminated | Pennsylvania | Details |
| Biologics | Mid-South Regional Blood Center | Class II | Terminated | Tennessee | Details |
| Devices | PSC Industries Inc | Class II | Ongoing | Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines. | Details |
| Drugs | Noven Pharmaceuticals, Inc. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom. | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France. | Details |
| Devices | GE OEC Medical Systems, Inc | Class I | Completed | Worldwide Distribution - US (nationwide) | Details |
| Devices | Arjo, Inc. dba ArjoHuntleigh | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey | Details |
| Devices | Maquet Cardiovascular Us Sales, Llc | Class I | Ongoing | Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom. | Details |
| Devices | Philips Medical Systems (Cleveland) Inc | Class II | Ongoing | Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland. | Details |
| Food/Cosmetics | Coca-Cola Refreshments, USA Inc. | Class II | Ongoing | MO, IA and IL. | Details |
| Devices | Integra LifeSciences Corp | Class II | Completed | International Only Distribution, including the countries of Thailand and Japan. | Details |
| Food/Cosmetics | Mutual Trading Company Inc | Class I | Completed | California | Details |
| Veterinary | Manna Pro Corp | Class III | Ongoing | AZ, CO, MT, UT, CA, NV, OR, MO, WI, IL, MN, TX, AR, FL, PA, NY, VA | Details |
| Devices | Impac Medical Systems Inc | Class II | Ongoing | Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom. | Details |
| Food/Cosmetics | Snyder's - Lance Inc. | Class II | Ongoing | AL, AR, AZ, FL, GA, IL, IN, KY, LA, MD, ME, MI, MO, MS, NC, NM, PA, SC, TN, TX, VA and WV. | Details |
| Food/Cosmetics | Pacific Giant, Inc | Class II | Ongoing | nationwide | Details |
| Food/Cosmetics | Winter Gardens Quality Foods Inc | Class II | Ongoing | DE, PA, MD, VA Canada | Details |
| Devices | Abbott Point Of Care Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) | Details |
| Devices | Zimmer, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom. | Details |
| Food/Cosmetics | Inventure Foods | Class II | Ongoing | Nationwide in the US and in Canada | Details |
| Devices | PSC Industries Inc | Class II | Ongoing | Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI. | Details |
| Food/Cosmetics | Wanchese Fish Company | Class II | Ongoing | Product were distributed to NY, SC, KS, PA, DE, TN, NC, FL, NJ, AL, and VA. | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA | Details |
| Food/Cosmetics | Minnesota Best Maid Cookie Co, Inc. | Class II | Ongoing | FL, KY, MI, OH | Details |
| Devices | Stryker Endoscopy | Class II | Ongoing | Worldwide Distribution--USA (nationwide) | Details |
| Food/Cosmetics | Cosmo's Food Products, Inc. | Class II | Terminated | AZ, AR, TN, GA, TX, WI, IL, NC, SC, VA, WV, OH, KY, AL, NJ, MD, CO, WY, MI, IN, UT, ID, FL, KS, MO, NE, NV, MN, SD, OK, OR, WA, MO, PA, | Details |
| Food/Cosmetics | Henrys Farm Inc. | Class I | Ongoing | Product was distributed to MD, VA and Washington, D.C. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. | Details |
| Food/Cosmetics | LEASA Industries Co., Inc. | Class I | Ongoing | Distributed to retail wholesalers and distributors in Florida. | Details |
| Food/Cosmetics | Coca-Cola Refreshments USA, Inc. | Class II | Ongoing | TX | Details |
| Devices | superDimension, Inc | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom. | Details |
| Devices | Smiths Medical ASD, Inc. | Class II | Ongoing | US Nationwide Distribution | Details |
| Drugs | GlaxoSmithKline Inc | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Dole Fresh Vegetables Inc | Class I | Ongoing | VA, NC. KY. SC. TN. GA | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Terminated | Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA | Details |
| Drugs | VistaPharm, Inc. | Class II | Ongoing | Nationwide | Details |
| Devices | Cardiovascular Systems, Inc. | Class II | Ongoing | Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX. | Details |
| Food/Cosmetics | Giusto's Specialty Foods LLC | Class II | Ongoing | CA, HI, WA. | Details |
| Drugs | Kimberly-Clark Corporation | Class II | Ongoing | Nationwide and Canada | Details |
| Food/Cosmetics | Banner Mountain Sprouts Inc | Class I | Ongoing | CA | Details |
| Devices | Elekta, Inc. | Class II | Ongoing | Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI. | Details |
| Devices | Elekta, Inc. | Class II | Ongoing | US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI | Details |
| Drugs | ASTRA ZENECA Lp | Class III | Ongoing | Nationwide. | Details |
| Devices | Vital Signs Devices, a GE Healthcare Company | Class II | Ongoing | Nationwide Distribution. | Details |
| Food/Cosmetics | Dole Fresh Vegetables Inc | Class I | Ongoing | AL, FL, GA, MD, NC, PA, SC, TN and VA | Details |
| Devices | Draeger Medical Systems, Inc. | Class II | Ongoing | Nationwide Distribution-USA (nationwide) and Puerto Rico. | Details |
| Food/Cosmetics | Fruiti Pops Inc. | Class I | Ongoing | Per firm, the product is distributed in Southern Califormia and are sold by push cart vendors and ice cream trucks. | Details |
| Food/Cosmetics | Rhee Brothers Incorporated | Class II | Ongoing | The product was distributed nationwide. | Details |
| Drugs | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Class III | Ongoing | Nationwide and Puerto Rico. | Details |
| Food/Cosmetics | Pacific International Marketing | Class I | Ongoing | CA and NV | Details |
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