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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Devices Handicare Accessibility Class II Ongoing Worldwide distribution: USA (Nationwide) and country of: Canada. Details
Devices Siemens Medical Solutions USA, Inc Class II Ongoing Nationwide Distribution Details
Devices Carestream Health Inc. Class II Ongoing Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand. Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics OneBlood, Inc. Class II Terminated Florida Details
Biologics South Texas Blood & Tissue Center Class II Terminated Florida; Texas Details
Devices Elekta, Inc. Class II Ongoing Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV. Details
Biologics Lions Eye Bank For Long Island Class III Terminated Syria Arab Republic; New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Donor Network of Arizona Class II Terminated Arizona Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated Venezuela Details
Biologics Lions Eye Bank For Long Island Class III Terminated Venezuela Details
Biologics Lions Eye Bank For Long Island Class III Terminated Venezuela Details
Biologics Lions Eye Bank For Long Island Class III Terminated Syria Arab Republic Details
Biologics Lions Eye Bank For Long Island Class III Terminated Egypt; New York Details
Biologics Lions Eye Bank For Long Island Class II Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated Syria Arab Republic; New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated Syria Arab Republic; New York Details
Biologics Lions Eye Bank For Long Island Class II Terminated California Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Eye Bank Of Wisconsin, Inc. Class III Terminated Wisconsin Details
Biologics Lions Eye Bank For Long Island Class III Terminated California Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York; Venezuela Details
Drugs Amneal Pharmaceuticals of New York, LLC. Class II Ongoing IL, NH, NJ, NY, OH, RI, TN Details
Veterinary Virbac Corporation Class III Ongoing Distribution was made to CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR, PA, TN, TX, WI, Firm also distributed to PR. Details
Biologics Kaiser Foundation Hospital Class II Terminated California Details
Biologics Southern California Permanente Medical Group Blood Donor Ctr Class II Terminated California Details
Devices Insight Instruments, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey. Details
Devices Carestream Health Inc. Class II Ongoing Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV. Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class II Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated North Carolina; New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Biologics Lions Eye Bank For Long Island Class III Terminated New York Details
Devices Bayer Healthcare Llc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan. Details
Devices Edwards Lifesciences, LLC Class II Ongoing Nationwide Distribution. Details
Devices Siemens Healthcare Diagnostics, Inc Class III Ongoing Nationwide Distribution including MD, PA, and CT. Details
Devices Steris Corporation Class II Ongoing Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin. Details
Veterinary Zoetis Inc Class II Ongoing Product was distributed to the following states: GA, AR, OK, TX, and VA. Details
Devices Pinook-Usa Class II Ongoing Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada. Details
Devices Zimmer, Inc. Class II Ongoing International distribution: Japan only. Details
Food GE PHARMA LLC - Class II Ongoing Nationwide and Worldwide Details
Devices Roche Diagnostics Operations, Inc. Class II Ongoing Nationwide Distribution and Puerto Rico Details
Devices Baxter Healthcare Corp. Class II Ongoing Worldwide Distribution - USA (nationwide) and the country of Canada. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe. Details
Devices Siemens Healthcare Diagnostics, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and Mexico. Details
Drugs Amgen, Inc. Class II Ongoing Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe. Details
Devices SEPPIM SAS Class II Ongoing Worldwide Distribution - US including the states of KY and UT and the country of Sweden. Details
Devices Fresenius Medical Care Holdings, Inc. Class II Ongoing USA Nationwide Distribution Details
Devices Smiths Medical ASD, Inc. Class II Ongoing Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY. Details
Devices ITC-Nexus Dx Class II Ongoing Nationwide Distribution including Arizona andTexas. . Details
Devices Baylis Medical Corp * Class I Ongoing Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy. Details
Food J M Smucker Co Class II Ongoing Product was shipped to the following states: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MO, MS, NC, NE, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and WY. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. . Details
Food Safeway Inc Class I,Class II Terminated Alaska, Arizona, California, Colorado, Washington, DC, Delaware, Hawaii, Idaho, Illinois, Maryland, Montana, Nebraska, New Mexico, Nevada, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wyoming Details
Drugs Mylan Pharmaceuticals Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Hamilton Medical, Inc. Class II Ongoing Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI. Details
Devices Helix Medical LLC Class III Ongoing Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy. Details
Devices Insulet Corporation Class II Ongoing Worldwide Distribution - USA Nationwide and the country of Israel. Details
Food Giant Eagle, Inc. Class I Ongoing MD, OH, PA, WV Details
Food American Laboratories Inc Class II Ongoing Distribution was made to IA, UT, NV, NE and CA. Details
Food Vitalab Co Inc Class II Ongoing Distribution was made both retail and wholesale to AZ, CA, CO, FL, GA, IA, IL, KS, KY, LA, MD, MI, MN, NJ, MN, MO, NC, NE, NH, NY, OH, OR, PA, TX, WA and WI. Distribution was made to PR. Details
Drugs West-Ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE. Details
Devices Richard Wolf Medical Instruments Corp. Class II Ongoing Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico. Details
Drugs Sandoz, Inc Class II Ongoing Nationwide Details
Devices Invacare Corporation Class II Ongoing Worldwide Distribution - USA including PA and Internationally to Canada. Details
Devices Sorin Group Deutschland GmbH Class II Ongoing Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain. Details
Devices Ethicon Endo-Surgery Inc Class II Ongoing Worldwide Distribution in the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia. and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia. Details
Devices Mesa Laboratories, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the country of Canada. Details
Devices EKOS Corporation Class II Ongoing Worldwide Distribution in Germany only. Details
Food yoders country market Class I Ongoing Nationwide. Details
Devices Intuitive Surgical, Inc. Class II Terminated Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela. Details
Devices Medtronic Vascular, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Smith & Nephew Inc Class II Ongoing USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN. Details
Food Threshold Enterprises Ltd Class II Ongoing The product was distributed Nationwide. Details
Devices Intuitive Surgical, Inc. Class III Ongoing Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, South Korea, Sweden, Switzerland, Taiwan, and Turkey. Details
Food Kashmir Crown Baking LLC Class I Ongoing CA, Canada Details
Devices Trumpf Medical Systems Class III Ongoing US Distribution: NJ only Details
Devices St. Jude Medical Class II Ongoing US distribution: KS, MA, UT,TX, KY, OH. Details
Food Irwin Naturals Class II Ongoing Nationwide in US Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
Devices Vital Images, Inc. Class II Ongoing Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine. Details
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