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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American National Red Cross Class II Terminated Utah. Details
Biologics American National Red Cross Class II Terminated Oregon and California. Details
Biologics American Red Cross Blood Services Class II Terminated IA Details
Biologics American National Red Cross Class II Terminated California and Washington. Details
Biologics LifeServe Blood Center Class III Terminated Iowa Details
Food LL Bakery, Inc. Class I Ongoing HI, WA, and CA Details
Devices Bion Enterprises Ltd Class III Completed Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro) Details
Drugs TG United, Inc. Class II Ongoing FL, MS, SC, LA and TX Details
Drugs Novartis Consumer Health Class III Ongoing Nationwide and Puerto Rico, and Panama. Military distribution made. Details
Biologics Lifesouth Community Blood Centers, Inc. - Mobile Region Class II Terminated Alabama Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics LifeShare Blood Centers Class II,Class III Terminated Louisiana Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland; Florida; New York Details
Biologics Community Blood Bank of Erie County Class III Terminated Pennsylvania; New York Details
Biologics Community Blood Centers of South FL, Inc. Class II Terminated Florida Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Florida Details
Biologics American Red Cross Blood Svs. Indiana-Ohio Region Class II,Class III Terminated California; Indiana Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics New York Blood Center, Inc. Class II Terminated New York Details
Biologics Community Blood Centers of South Florida, Inc. Class II,Class III Terminated Switzerland; Florida Details
Biologics DCI Biologicals LLC Class II Terminated California Details
Biologics Blood Assurance Inc Class II Terminated Tennessee Details
Biologics Dept Of The Navy, Naval Medical Center Class II Terminated Virginia Details
Biologics Dept Of The Navy, Naval Medical Center Class II Terminated Virginia Details
Biologics West Tennessee Regional Blood Center Inc Class II Terminated Tennessee Details
Biologics Dept Of The Navy, Naval Medical Center Class II Terminated New Jersey Details
Biologics OneBlood / dba CBCF Class II,Class III Terminated Florida Details
Biologics LifeServe Blood Center Class II Terminated Nebraska Details
Biologics LifeServe Blood Center Class II Terminated Iowa; South Carolina Details
Biologics Inova Health Care Services, Inova Blood Donor Services Class II Terminated New York; Indiana Details
Biologics Blood Systems Inc Class II Completed Arizona Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey. Details
Biologics Rhode Island Blood Center Class II Terminated New York Details
Biologics Community Blood Centers of South Florida, Inc. Class II Terminated Florida Details
Devices Medtronic Xomed, Inc. Class I Ongoing Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom. Details
Drugs Petnet Solution Inc Class II Terminated Within the state of CA. Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide Details
Drugs Legacy Pharmaceutical Packaging LLC Class III Ongoing Distribution was made to IN. Details
Devices Shimadzu Medical Systems Class II Ongoing US Nationwide Distribution Details
Devices I-Flow LLC Class II Completed Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI. Details
Food Chemi- Source Inc, Nutra Pak Class II Ongoing nationwide Details
Biologics American National Red Cross Class II,Class III Terminated Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana Details
Biologics Immucor Inc Class III Ongoing Nationwide; Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan Details
Biologics Arkansas Lions Eye Bank & Laboratory Class III Terminated Arkansas Details
Biologics North Carolina Eye Bank, Inc. (The) Class III Terminated Egypt Details
Devices Kreg Medical Inc. Class II Completed Nationwide Distribution including IL and IN. Details
Devices Leica Microsystems, Inc. Class II Ongoing Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand. Details
Devices SpineFrontier, Inc. Class II Completed Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica. Details
Devices Alcon Grieshaber AG Class II Ongoing Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turknenistan, Venezula, and Viet Nam. Details
Food Prosperity Resources International, Inc. Class III Ongoing Retail customers in New York State. Details
Devices Berchtold Corp. Class II Ongoing Nationwide Distribution Details
Devices Covidien LP Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela Details
Devices American Optisurgical Inc Class II Ongoing Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI. Details
Food Nestle USA, Inc - Northbrook Pizza Head Office Class II Ongoing US nationwide distribution only. NO OUS. Details
Devices Carl Zeiss Meditec, Inc. Class II Ongoing US Nationwide Distribution. Details
Devices American Optisurgical Inc Class II Ongoing Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines. Details
Drugs THE COMPOUNDING SHOP, INC. Class II Ongoing Florida, California, Minnesota, and Maine Details
Food Whole Foods Market Group Inc. Class I Terminated Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam. Details
Devices Maytex Corp Class II Ongoing Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico. Details
Devices GE Healthcare, LLC Class II Ongoing Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom. Details
Food Smiling Hill Farm, Inc. dba Silvery Moon Creamery Class II Ongoing ME, NH, CT Details
Drugs Pentec Health Class II Ongoing Dialysis Centers Direct to patient Details
Devices Cordis Corporation Class II Ongoing Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand Details
Food Arizona Beverages USA LLC Class III Ongoing CT, PA, NY, NJ, MI, IL and WI. Details
Devices Optovue, Inc. Class III Ongoing Distributed Nationwide and in Canada. Details
Devices Symbios Medical Products, LLC Class I Ongoing US Nationwide distribution. Details
Devices Biomet, Inc. Class II Ongoing Distributed in New York. Details
Devices Intuitive Surgical, Inc. Class II Ongoing Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela. Details
Devices AGFA Corp. Class II Ongoing Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada Details
Devices Siemens Healthcare Diagnostics, Inc Class II Ongoing Nationwide Distribution. Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Gyrus Acmi, Incorporated Class II Ongoing Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom. Details
Food HP Hood LLC Class II Ongoing NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ, IL, FL, WI, AL, ME, OH, NE, NV, IN, and CA Details
Devices Hill-Rom, Inc. Class II Ongoing Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam. Details
Devices Zimmer Surgical Inc Class II Ongoing Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT. Details
Drugs Physicians Total Care, Inc. Class II Completed Nationwide Details
Drugs Physicians Total Care, Inc. Class III Completed Nationwide Details
Devices Coloplast Manufacturing US, LLC Class II Ongoing US Distribution to: KY, MI, OH, PR, TX, and VA. Details
Drugs Hospira Inc. Class II Ongoing Nationwide and Puerto Rico Details
Devices Stryker Instruments Div. of Stryker Corporation Class II Ongoing USA Nationwide Distribution Details
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