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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American Red Cross Blood Services Class III Terminated Nebraska, Michigan Details
Biologics Community Blood Bank, Inc. Class III Terminated California Details
Biologics American Red Cross Blood Services Class II Terminated Nebraska; Ohio; Pennsylvania; New Jersey; Switzerland Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American National Red Cross (The) Class III Terminated Arizona Details
Biologics San Diego Blood Bank Class III Terminated California Details
Biologics San Diego Blood Bank Class II Terminated California Details
Biologics Childrens Hospital Los Angeles Class III Terminated CA Details
Biologics Community Blood Bank, Inc. Class II Terminated California. Details
Biologics Community Blood Bank, Inc. Class II Terminated CA. Details
Biologics American National Red Cross (The) Class II Terminated OH Details
Biologics San Diego Blood Bank Class II Terminated California Details
Biologics Community Blood Bank, Inc. Class II Terminated FL, CA. Details
Biologics BioLife Plasma Services L.P. Class II Terminated California Details
Biologics Blood Systems, Inc. Class II,Class III Terminated AZ, TX, NM, AL, MS, UK, Switzerland Details
Biologics American Red Cross Blood Services Class III Terminated Kansas; Oklahoma; Texas Details
Biologics Octapharma Plasma Inc Class III Terminated Switzerland Details
Biologics BioLife Plasma Services L.P. Class II Terminated Austria Details
Biologics Csl Plasma Inc Class II Terminated Illinois , Germany and Switzerland Details
Biologics Community Blood Bank, Inc. Class II Terminated California. Details
Biologics ZLB Bioplasma, Inc. Class II Terminated IL, Germany, and Switzerland. Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois. Switzerland and Germany. Details
Biologics Octapharma Plasma Inc Class II Terminated Switzerland Details
Biologics HemaCare Corporation Class II Terminated CA Details
Food Combs Produce Class II Ongoing TX, OK, CO Details
Devices Laserworld Usa Inc Class II Ongoing US Distribution including the states of CA, CO, FL, KS and PA. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam Details
Devices B Braun Medical, Inc. Class I Ongoing Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV. Details
Biologics Rochester Eye and Human Parts Bank, Inc. Class II Terminated New York Details
Devices Synthes USA HQ, Inc. Class II Ongoing Distributed in MA. Details
Drugs Boehringer Ingelheim Roxane Inc Class III Ongoing Nationwide Details
Biologics Plasma Biological Services Class III Terminated California Details
Biologics Interstate Blood Bank, Inc. of Wisconsin Class III Terminated California Details
Biologics Wellmont Health System Dba Marsh Regional Blood Center Class II,Class III Terminated Tennessee; Virginia; Maryland Details
Biologics Michigan Blood Class II Terminated Michigan Details
Biologics Ogden Medical Center, Inc. Class II Terminated Utah Details
Biologics DCI Biologicals, LLC Class II Terminated United Kingdom Details
Biologics Midsouth Eye Bank for Sight Restoration Inc Class II Terminated Venezuela Details
Biologics RTI Biologics, Inc. Class III Terminated Tennessee; Ohio; Colorado; Indiana; New York; Texas Details
Biologics RTI Biologics, Inc. Class III Terminated Tennessee; Oklahoma; Korea, Republic Of(South); Alabama; Louisiana; Florida; Indiana; Texas Details
Devices Rauland-Borg Corp Class II Ongoing Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam. Details
Food Mike's Quality Meats, Inc. Class II Terminated Two restaurants - one in Alaska and one in Oregon Details
Devices Instrumentation Laboratory Co. Class II Ongoing Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam. Details
Food American Yeast Corporation Class II Ongoing The recalled products were distributed to MD, CT, PA, and NY Details
Devices Assuramed Class II Ongoing Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA. Details
Food Lucy's Kitchen, Inc. Class II Ongoing PR only Details
Devices Spine Smith Holdings, LLC Class II Completed Distributed in FL. Details
Food Tasty Bake Inc Class II Ongoing distributed in Idaho, Oregon and Washington. Details
Devices Medtronic Sofamor Danek USA Inc Class II Ongoing USA Nationwide Distribution in the state of GA, AK, WA, and CA. Details
Food Novartis Consumer Health Class III Ongoing Distribution was made nationwide. Details
Devices Villa Radiology Systems LLC Class II Ongoing US Nationwide Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO. Details
Devices Sonogage Inc Class II Ongoing Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA; and countries of Canada and Mexico. Details
Devices Smith & Nephew, Inc. Endoscopy Division Class II Ongoing Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela. Details
Devices 3M Company - Health Care Business Class II Ongoing Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA.. Details
Devices Tornier, Inc Class II Ongoing .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM Details
Devices Churchill Medical Systems, Inc. Class II Ongoing Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA. Details
Food Jean's Cake Class II Ongoing PR only. Details
Food G. Debbas Chocolatier, Inc. Class I Ongoing One customer in Chicago, IL Details
Devices Ebi, Llc Class II Ongoing Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX. Details
Drugs JCB Labs LLC Class II Ongoing Nationwide and Guam Details
Drugs Leiter's Pharmacy Class II Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM. Details
Food New Dream Team Class III Terminated OR. CO. TX NY, NV Details
Drugs Dr. Reddy's Laboratories, Inc. Class II Ongoing Nationwide (& Puerto Rico) Details
Food Tampa Maid Foods, Inc. Class I Ongoing Product was distributed to the following states: Virginia and Tennessee Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution - USA (nationwide) including the states of : AL AZ, CA, CO, CT, FL, GA, IL, IN, MD,MI, MO, NJ, NY, NC, OK, PA, TX and WI., and the countries of : AUSTRIA, BELGIUM, CANADA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, JAPAN, LEBANON, NORWAY, PORTUGAL, SPAIN, SWEDEN and TAIWAN. Details
Food Premier Foods, LLC Class I,Class II Ongoing MS and NJ Details
Devices Camlog Usa Class II Ongoing USA Distribution in the states of NH, MD, CO, and IL. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution - USA (nationwide) including the states of : AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC, TN, TX, VA, WA, WV, WI and WY., and the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, COSTA RICA. CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MOROCCO, NETHERLAND, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VENEZUELA. Details
Devices Cincinnati Sub-Zero Products Inc Class II Ongoing Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM. Details
Devices GE Healthcare, LLC Class II Completed Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA. Details
Drugs Procter & Gamble Co Class II Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE. Details
Drugs Watson Laboratories Inc Class III Ongoing Nationwide Details
Drugs Medaus, Inc. Class II Ongoing Nationwide Details
Devices Zeppessis Reprocessing, LLC Class II Ongoing Distributed in the states of California, Idaho, Oregon, and Washington. Details
Devices King Systems Corp. Class III Ongoing Distributed in NY. Details
Devices Integra LifeSciences Corp. d.b.a. Integra Pain Management Class II Ongoing Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI. Details
Food Cains Foods L.P. Class I Ongoing AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, ME, MS, MT, NC, NH, NJ, NY, NM, OH, PA, RI, SC, TN, VA, WY Details
Drugs Northern New England Compounding Pharmacy LLC Class II Terminated CT Details
Devices Biomet 3i, LLC Class II Ongoing Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom. Details
Devices Implantech Associates Inc Class II Ongoing Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel. Details
Drugs Avella of Deer Valley, Inc. Class II Ongoing Nationwide and Puerto Rico Details
Food General Mills, Inc Class II Ongoing AL, AZ, AR, CA, CO,CT, FL, GA, ID, IL, IN, KS,KY, LA, ME, MD,MA, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY. Details
Devices Access Scientific Inc Class II Completed Distributed in MI and TX. Details
Food JTM Provisions Co Inc Class I Ongoing Product was shipped to one manufacturer in MN. Details
Devices Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Class II Ongoing Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia. Details
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