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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Community Blood Bank of Lancaster County Medical Society Class III Terminated NE Details
Biologics Ogden Medical Center, Inc. Class II Terminated UT, Switzerland Details
Biologics Poudre Valley Health Care, Inc Class II Terminated CO, NJ Details
Biologics Poudre Valley Health Care, Inc Class II Terminated CO, NJ Details
Biologics University of Colorado Hospital Class III Terminated CO Details
Biologics Community Blood Center Of Gtr KC Class II Terminated MO, CA. Details
Biologics Mississippi Valley Regional Blood Center Class III Terminated Pennsylvania Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas; Missouri Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Kansas Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri; Kansas Details
Biologics Community Blood Bank of Lancaster County Medical Society Class II Terminated NE; Austria Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Bank of Lancaster County Medical Society Class III Terminated NE Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Center Of Gtr KC Class II Terminated MO Details
Biologics Community Blood Center Of Gtr KC Class III Terminated MO Details
Biologics American National Red Cross (The) Class II Terminated MA Details
Biologics Community Blood Center Of Gtr KC Class III Terminated Missouri Details
Food Sunshine Peanut Company Class II Ongoing Product was distributed to distributors in CA, FL, NJ, and WA. Details
Food Sun Boricua Pa'l Mundo Inc. Class II Ongoing Puerto Rico only Details
Devices Sunquest Information Systems, Inc. Class III Completed Nationwide distribution Details
Devices Osteotech Inc Class II Ongoing Worldwide Distribution - USA (nationwide) and Internationally. Details
Biologics Blood Assurance Inc Class II Terminated Tennessee; North Carolina; Indiana Details
Biologics Our Lady Of The Lake Hospital Inc Class II Terminated Louisiana Details
Biologics HCSC-Blood Center Class II Terminated Pennsylvania 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 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
Biologics Community Blood Center Class III Terminated Ohio Details
Biologics Tri-counties Blood Bank Class II Terminated California Details
Biologics Blood Assurance Inc Class II,Class III Terminated Florida; Indiana Details
Biologics Blood Assurance Inc Class II,Class III Terminated Tennessee; Indiana Details
Biologics Community Blood Center of Carolinas Class II Terminated North Carolina Details
Biologics Blood Assurance Inc Class II,Class III Terminated South Carolina; New York; Indiana Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Biologics Blood Systems, Inc. Class II Terminated Nevada, Arizona, Mississippi Details
Food Ernesto Tropical Food, Inc Class II Ongoing Puerto Rico only (distributors and retailers in the local area) Details
Devices Ethicon Endo-Surgery Inc Class I Ongoing Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, 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, WY and the countries of: ARGENTINA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MALAYSIA, MEXICO, NEPAL, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, and YEMEN. There was one Canadian consignee and 43 U.S. Government consignees. Details
Food Splendid Products Class I Ongoing Nationwide distribution. Details
Devices The Anspach Effort, Inc. Class II Ongoing Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan. Details
Food Harry and David Operations, Inc. Class I Ongoing Internet sales to 44 states and the District of Columbia Details
Devices Linvatec Corp. dba ConMed Linvatec Class II Ongoing Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL Details
Devices Zimmer, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil. Details
Food J & J Snack Foods Corporation Class I Ongoing Nationwide Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom Details
Food Spartan Central Kitchen Class II Ongoing MI and OH only. Details
Food Whole Foods Market Class I Ongoing Nationwide to 21 states Details
Devices Beckman Coulter Inc. Class II Ongoing Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan. Details
Food Lovin Oven, LLC Class II Terminated Nationwide in the US Details
Food Caito Foods Service, Inc. Class I Ongoing 4 Distributors in WI, IN, IL, CA with further nationwide distribution to retail stores Details
Food SUNFRESH NATURAL LLC. Class II Completed Nationwide Details
Food Lehi Valley Trading Co. Class II Ongoing US States: AZ, NJ, NM, NJ, TX, LA, CA, WI, WA, VT, GA, and FL. No international distribution. Details
Food Liberty Fruit Co Inc - Carols Cuts Div Class I Terminated Distribution was made to KS. Details
Food Floyd Peterson Company Inc. Class I Ongoing Product distributed to distributors, retailers, and restaurants in Oregon and Washington. Details
Food Ralcorp Frozen Bakery Products Class II Ongoing Kentucky, Michigan, Ohio Details
Devices Aesculap, Inc. Class II Ongoing Within the US, product was distributed to PA and TN. Details
Drugs Sandoz Incorporated Class III Ongoing Nationwide Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE. Details
Food Southwind Foods LLC dba Great American Seafood Imports Co. Class III Terminated CA, AZ, TX Details
Food Oregon Ice Cream, LLC Class II Ongoing Product was distributed to distribution centers in CA, CO, CT, IA, IN, NH, and PA. Details
Food Bottling LLC dba Pepsi Beverages Company Class II Terminated Arizona Details
Devices Trumpf Medical Systems, Inc. Class II Ongoing Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI. Details
Food Specialty Commodities, Inc. Class I Ongoing CA, GA, IL, MO, NY, TX, WA Details
Food World Food LLC. Class I Ongoing Distributed throughout FL. Details
Food Publix Super Markets Class I Ongoing Florida, Georgia, South Carolina, Alabama, and Tennessee Details
Food Gretchen's Shoebox Express Class I Terminated Product was distributed to retail stores in Washington. Details
Food Richmond Baking of Georgia Inc Class II Ongoing AZ, CA, FL, HI, ID, IL, IN, KS, MI, NJ, OR, PA, TN, TX, VA and WA. Details
Food C.G. Higgins Confections, LLC Class I Ongoing Retailers and end users located in NM, USA. Details
Food Newman's Own Organics Class I Ongoing The product is distributed in the US only. Firm's distributors are location nationwide: AZ, CA, CO, CT, GA, NH, IA, IL, IN, NJ, NV, OR, PA, TN, TX, WA. However, the firm's distributors service a large area and can ship to retailers outside of their state. Details
Food Whole Foods Market Group Inc. Class I Ongoing Massachusetts, Rhode Island, Maine, Connecticut, New York and New Jersey Details
Food Gretchen's Shoebox Express Class I Ongoing Product was distributed at cafe stores in Oregon and Washington only. There are no Canadian consignees. Details
Food Late July Snacks, LLC Class I Ongoing Nationwide Details
Devices MOOG Medical Devices Group Class II Ongoing Nationwide Distribution including California Details
Devices Teleflex Medical Class II Ongoing Nationwide Distribution including the state of Nevada. Details
Food Kilwin's Quality Confections, Inc. Class I Ongoing Michigan and Florida Distribution centers with Retail stores in Florida, Georgia, Indiana, Michigan, North Carolina, Ohio, South Carolina, Tennessee, and Wisconsin receiving product. Details
Drugs Earthborn Products, Inc. Class II Ongoing Nationwide Details
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