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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics International BioResources, LLC Class III Terminated North Carolina Details
Biologics Blood Bank of San Bernardino and Riverside Counties Class II Terminated CA Details
Biologics American National Red Cross (The) Class III Terminated OH Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics Blood Systems, Inc. Class III Terminated AZ Details
Biologics HemaCare Corporation Class II Terminated California Details
Biologics Blood Systems, Inc. Class II Terminated AZ Details
Biologics Childrens Hospital Los Angeles Class III Terminated CA Details
Biologics BioLife Plasma Service, LP Class II Terminated California Details
Biologics American National Red Cross (The) Class III Terminated NY & PA Details
Biologics San Diego Blood Bank Class II Terminated CA Details
Biologics American Red Cross Blood Services Class II Terminated Multiple states within the U.S. Firm could not provide specifics. Details
Biologics HemaCare Corporation Class II Terminated CA Details
Devices Synthes USA HQ, Inc. Class II Ongoing Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic. Details
Devices Synthes USA HQ, Inc. Class II Ongoing Nationwide Distribution including CA,and VA. . Details
Devices Invacare Corporation Class II Ongoing Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, 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. Internationally to Canada, Australia, Bermuda, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa. Details
Biologics Blood Systems, Inc. dba United Blood Services Texas Class II Terminated TX Details
Biologics OneBlood, Inc. Class II,Class III Terminated Switzerland; FL Details
Biologics OneBlood, Inc. Class II Terminated FL Details
Biologics OneBlood, Inc. Class II Terminated FL Details
Biologics Central Blood Bank Class II Terminated PA Details
Biologics LifeSource Class II Terminated Pennsylvania Details
Biologics Blood Center Hammond Laboratory (the) Class III Terminated Louisiana Details
Biologics The Blood Center Class II Terminated Louisiana Details
Biologics Blood Centers of the Pacific - Irwin Center Class II Terminated Austria; California Details
Biologics OneBlood, Inc. Class II,Class III Terminated Switzerland; Florida; New York Details
Biologics LifeShare Blood Centers Class II Terminated Texas Details
Biologics Knoxville Plasma Corporation Class II Terminated Tennessee; California Details
Biologics Community Blood Bank of Erie County Class II Terminated Pennsylvania Details
Biologics American Red Cross Blood Services Heart of America Region Class II Terminated Illinois Details
Devices Microgenics Corp Class II Ongoing US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL Details
Drugs Core Pharma Llc Class II Ongoing Nationwide Details
Devices Stryker Medical Division of Stryker Corporation Class II Ongoing Worldwide Distribution - USA including MI, WI, VA and internationally to Canada. Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY. Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico. Details
Devices Elekta, Inc. Class II Ongoing Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA. Details
Devices Maquet Cardiovascular Us Sales, Llc Class II Ongoing Worldwide Distribution, including Nationwide (US) and foreign countries. Details
Devices Maquet Cardiovascular Us Sales, Llc Class II Ongoing Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden. Details
Devices Endoplus, Inc. Class II Ongoing Distributed in the states of FL, TX, and VA. Details
Devices Becton Dickinson & Company Class II Ongoing Worldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico.. Details
Food Gourmet Express Marketing, Inc. Class II Ongoing US: Nationwide (IL, IN, MI, MO, NY, OH) Details
Food Blythedale Farm Inc. Class II Ongoing VT, NH, CT, RI, ME, NY, MA, DC, IL, CA Details
Devices CareFusion 303, Inc. Class II Ongoing Nationwide Distribution including CA Details
Devices CareFusion 303, Inc. Class II Ongoing Class II Recall - United States ***Center Recommended Depth - Consumers/Users** Details
Devices CareFusion 303, Inc. Class II Ongoing Nationwide Distribution Details
Food Garden-Fresh Foods, Inc. Class I Ongoing retail Spartan stores located in MI and Toledo, OH. Expanded recall: WI, MN, IA, IL, OH, IN, TX, FL, MA,MO, MI, PA, AZ, CA. Details
Food Snoqualmie Falls Candy Factory, LLC Class II Ongoing distributed in WA. Details
Food Mothers Milk Bank Class II Terminated Product was distributed to 6 hospitals in Honolulu and California. Details
Devices Horiba Instruments, Inc dba Horiba Medical Class III Ongoing Worldwide Distribution - USA including the country of Canada. Details
Devices Stryker Endoscopy Class II Ongoing Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland. Details
Food KDK Management, Inc., dba Bubbles Baking Co. Class I Ongoing CA & Arizona Details
Devices Smiths Medical ASD, Inc. Class II Ongoing Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA. Details
Devices Steris Corporation Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain. Details
Food Restaurant Depot Class II Ongoing NY, NJ, CT, RI, MA, PA, MD, VA Details
Food Maplehurst Bakeries, Inc. Class II Ongoing MI and OH. Details
Food Shenandoah Growers, Inc. Class III Terminated Product was distributed to PA, VA and MD. Details
Food Irene's Bakery & Gourmet Kitchen, Inc. Class I Ongoing Local and nationwide wholesale distributors and retail markets. Details
Food The Dannon Company, Inc Class II Ongoing Arizona, California, Colorado, Nevada, Utah, Washington, and Wyoming. 324 cases were distributed to govt/military/VA consignees. No foreign consignees. Details
Drugs Walgreens Co Class II Ongoing Nationwide Details
Food Semifreddi's Inc. Class II Ongoing Products were delivered to retail stores/cafes/restaurants throughout California and to AZ, CO, NE, NJ, NY, OR and WA Details
Devices Medtronic Xomed, Inc. Class II Completed Nationwide Distribution (US), including the states of CA, NE, GA, and IL. Details
Food American Nut Company Class II Ongoing CA, AZ, & WA Details
Food Taylor Farms Retail, Inc. Class II Terminated One account in Canada. Details
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