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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross, The Class II Terminated CA Details
Biologics American National Red Cross (The) Class II Terminated AZ Details
Biologics American National Red Cross (The) Class III Terminated AZ Details
Biologics American National Red Cross (The) Class III Terminated California Details
Biologics American National Red Cross (The) Class II,Class III Terminated CA Details
Biologics Biomat USA, Inc. Class II Terminated Spain Details
Biologics Tri-counties Blood Bank Class II Terminated CA Details
Biologics American National Red Cross (The) Class II Terminated Ohio, Virginia Details
Biologics American National Red Cross (The) Class III Terminated New York Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class III Terminated California Details
Biologics San Diego Blood Bank Class II Terminated California Details
Biologics Blood Systems, Inc. Class III Terminated Arizona Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class III Terminated California Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American National Red Cross (The) Class II Terminated AZ Details
Biologics Community Blood Bank, Inc. Class II Terminated California Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA, NY Details
Biologics BioLife Plasma Services L.P. Class II Terminated NY, KY, CA Details
Biologics Sight Society of Northeastern New York Lions Eye Bank@Albany Class II Terminated New York Details
Devices Ge Healthcare It Class II Ongoing Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen. Center Recommended Depth - Consumers/User** Details
Devices Carestream Health, Inc. Class II Ongoing Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN. Details
Devices GE Healthcare It Class II Ongoing Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia Details
Biologics OneBlood / dba CBCF Class II Terminated Florida; New York Details
Devices Sysmex America Inc Class II Ongoing Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada. Details
Biologics NOVARTIS VACCINES AND DIAGNOSTICS S.r.l Class II Completed Multiple U.S. States Details
Biologics The American National Red Cross - Southern Region Class III Terminated North Carolina Details
Biologics Arc Blood Services, New England Region Class III Terminated Massachusetts Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula. Details
Devices Carestream Health, Inc. Class II Ongoing Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom. 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
Devices DePuy Spine, Inc. Class II Ongoing Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY. Details
Biologics One Lambda Inc Class II Ongoing US nationwide and international: Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, Romania, Slovenia, Netherlands, Russia, Finland, Sweden, Spain and Portugal, Brazil, Chile, Bolivia, Paraguay, Costa Rica, Japan, South Africa, Turkey, Vietnam, China, and Malaysia. Details
Devices HemoCue AB Class II Ongoing Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia. Details
Devices HemoCue AB Class II Ongoing Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Worldwide Distribution - US (nationwide) and country of Mexico Details
Devices Toshiba American Medical Systems Inc Class II Ongoing Nationwide Distribution including and US Territory Puerto Rico Details
Biologics Jubilant HollisterStier, LLC Class II Completed Canada; Multiple U.S. States and Multiple Countries Details
Food American Importing Co, Inc Class II Ongoing CA, CO, IN, IA, KS, OR, UT, VA, WA. Details
Biologics Ortho Clinical Diagnostics Inc Class III Ongoing Nationwide Details
Devices Fujinon Inc Class II Ongoing Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada. Details
Devices Siemens Healthcare Diagnostics Inc Class II Ongoing Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam, Details
Drugs Fallon Wellness Pharmacy Llc Class II Ongoing NY & ME Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands. Details
Devices Baxter Healthcare Corp. Class II Ongoing Nationwide distribution. Details
Devices Baxter Healthcare Corp. Class II Ongoing US Distribution including the states of OK, GA, CA, MN, TX and HI. Details
Devices Integra Limited Class II Ongoing Nationwide Distribution Details
Food Schwebel Baking Company Class I Ongoing The product was shipped to the following states: IN, MI, NY, OH, PA & WV. Details
Devices Globus Medical, Inc. Class II Ongoing USA Nationwide Distribution. Details
Devices bioMerieux, Inc. Class II Ongoing Nationwide Distribution. Details
Devices Edwards Lifesciences, LLC Class I Ongoing Worldwide distribution: US (nationwide) and country of: Canada. Details
Food Conagra Inc Class I Ongoing The product was distributed to AL, AR, AZ, CA, CO, CN, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MI, NC, NE, NM, NV, NY, OH, OK, PE, SC, TN, TX, UT, VI, WA, WI and WY. No foreign distribution was made, including Canada. There may be one military client. The firm is gathering the distribution information and will forward that to KAN-DO as soon as it is ready. Details
Devices Medtronic Vascular, Inc. Class II Terminated International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom. Details
Devices Xoran Technologies, Inc. Class II Ongoing Worldwide Distribution - US nationwide Details
Devices Maquet Medical Systems USA Class II Ongoing Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO Details
Devices Xoran Technologies, Inc. Class II Ongoing Worldwide Distribution - Nationwide Details
Devices Xoran Technologies, Inc. Class II Ongoing Worldwide Distribution - US nationwide Details
Devices Xoran Technologies, Inc. Class II Ongoing Worldwide Distribution - Nationwide Details
Devices Xoran Technologies, Inc. Class II Ongoing Worldwide Distribution - US nationwide Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom. Details
Devices Small Bone Innovations, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico. Details
Devices Pentax Medical Company Class I Ongoing Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming. Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - Nationwide Distribution and the country of Canada.. Details
Devices S.A.E. AFIKIM Class II Ongoing Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin. Details
Devices Atossa Genetics, Inc. Class I Ongoing USA Nationwide Distribution in the states of: AL, CA, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, ND, NJ, NV, NY, OK, PA, SC, TN, TX, UT, VA, WA, Washington DC, and Puerto Rico. Details
Devices Intuitive Surgical, Inc. Class II Terminated Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. Details
Food American Laboratories Inc Class II Ongoing Distribution was made to IA, UT, NV, NE and CA. Details
Food Orange County Produce Class I Terminated CA Details
Food Epicure Food Corp. Class I Ongoing CT, DC, DE, MD, NJ, NY & PA Details
Food Price Chopper Supermarkets Class II Terminated NY, CT, VT Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom. Details
Devices Medtronic Neuromodulation Class II Ongoing Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela. Details
Food Kellogg Canada Corporate Office Class II Ongoing Canada Details
Devices Cordis Corporation Class II Ongoing Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama. Details
Food Barrel O' Fun Snack Foods Co. Class I Ongoing Retail Stores located in Colorado, Nebraska, New Mexico, South Dakota, and Wyoming. Details
Food Western Nut Company, Inc. Class II Ongoing Products distributed to Utah and California. No foreign, military/govt/VA consignees. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. . Details
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