Enforcement Report - Week of September 19, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Micro Typing Systems Inc. | Class II | Terminated | The product was distributed to 79 consignees throughout the USA and Canada. | Details |
| Devices | Biosense Webster, Inc. | Class II | Terminated | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom. | Details |
| Biologics | Life Technologies, Inc. | Class II | Ongoing | Nationwide; CANADA, BRAZIL, GERMANY, ALGERIA, ESTONIA, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ISRAEL, ITALY, JAPAN, POLAND, ROMANIA, SAUDI ARABIA, SWEDEN, SINGAPORE, TUNISIA, TAIWAN, URUGUAY, SOUTH AFRICA. | Details |
| Biologics | D. D. Eisenhower Army Med. Ctr. - Blood Bank | Class III | Terminated | NJ | Details |
| Devices | JK Products & Services, Inc | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and Canada | Details |
| Veterinary | Process Managers LLC | Class II | Ongoing | Nationwide distribution: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA, WA & WV. No shipments were made to foreign countries including Canada. | Details |
| Biologics | Blood Systems, Inc. dba United Blood Services | Class III | Terminated | TX | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | FL | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Devices | Exactech, Inc. | Class II | Ongoing | Nationwide distribution: USA state of: Arkansas only | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | CA | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | CA | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Switzerland; FL | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Switzerland; FL, NY | Details |
| Biologics | South Dakota Lions Eye and Tissue Bank, Inc. | Class II | Terminated | NC, Egypt | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide distribution: International only-country of: Terumo Dubai, UAE | Details |
| Devices | Philips Healthcare Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN | Details |
| Biologics | Indiana Blood Center | Class II | Terminated | Indiana | Details |
| Biologics | Community Blood Bank of Erie County | Class II | Terminated | Pennsylvania | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | Blood Systems, Inc. dba United Blood Services | Class II | Terminated | Texas | Details |
| Food/Cosmetics | Sunny Seafoods Inc | Class II | Ongoing | Massachusetts to Georgia. | Details |
| Biologics | Blood Systems, Inc. dba United Blood Services | Class II | Terminated | Texas | Details |
| Biologics | Blood Systems, Inc. dba United Blood Services | Class II | Terminated | Texas | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | Austria; Florida | Details |
| Biologics | Dci Biologicals Llc | Class II | Terminated | Israel | Details |
| Biologics | Meek Blood Center | Class II | Terminated | Texas | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | Florida | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | BloodCenter of Wisconsin, Inc | Class II | Terminated | Wisconsin | Details |
| Biologics | Arup Laboratories, Inc. | Class II | Terminated | Utah | Details |
| Biologics | Community Blood Center Of Gtr KC | Class II | Terminated | Missouri | Details |
| Veterinary | Nutra Blend LLC | Class II | Terminated | The product was distributed in MO. | Details |
| Food/Cosmetics | Garden-Fresh Foods, Inc. | Class I | Ongoing | AZ CA FL IA IL IN MA MI MN MO OH PA TX WI | Details |
| Food/Cosmetics | Ron Stockman Whole Foods | Class I | Ongoing | Products were sold directly to the consumers though our Whole Foods Market Retail stores in the state of Florida. | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAÚDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN. | Details |
| Devices | Sunquest Information Systems, Inc. | Class II | Completed | Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates. | Details |
| Devices | C.R. Bard, Inc., Urological Division | Class II | Ongoing | Nationwide distribution: USA | Details |
| Food/Cosmetics | Missa Bay, LLC | Class I | Ongoing | Alabama, Arkansas, Connecticut, Delaware, DC, Florida, Georgia, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carlina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and West Virginia. | Details |
| Devices | Intuitive Surgical, Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon | Details |
| Devices | Aesculap Implant Systems LLC | Class II | Ongoing | Nationwide Distribution-including the states of IL, MN, NV, OK, and TX. | Details |
| Devices | Capsule Tech Inc. | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK. | Details |
| Devices | Custom Medical Specialties, Inc. | Class II | Terminated | Nationwide Distribution including GA, MI, NY, and PA. | Details |
| Food/Cosmetics | Meijer Distribution, Inc | Class III | Ongoing | The 4 oz. product was distributed to 25 stores and the. 8 oz. product was distributed to 197 stores. Stores are located in Illinois, Indiana, Kentucky, Michigan, and Ohio. Product was distributed from Meijer's distribution centers located in lansing, Michigan; Newport, Michigan; and Tipp City, Ohio. | Details |
| Devices | Steris Corporation | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong. | Details |
| Devices | Hospira, Inc. | Class II | Ongoing | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands. | Details |
| Devices | Omni Life Science | Class II | Ongoing | Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands. | Details |
| Veterinary | Steve Pritchett Farms LLC | Class II | Ongoing | The firm distributed to one firm in Indiana. | Details |
| Devices | Elekta, Inc. | Class II | Ongoing | Nationwide Distribution including DC & MD | Details |
| Food/Cosmetics | T.F. Foods Incorporated | Class II | Terminated | Firm distributed to 6 direct consignees located in CA and NY. | Details |
| Veterinary | Breadfarm | Class II | Terminated | Retail sales at firm only. | Details |
| Devices | Advanced Sterilization Products | Class III | Ongoing | Nationwide Distribution. | Details |
| Devices | Lucero Medical LLC | Class II | Ongoing | US Nationwide Distribution | Details |
| Veterinary | Greer Laboratories Inc | Class III | Terminated | FL, IL, KS, MS, NJ, NY, OH, VA & Australia | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Worldwide Distribution -- USA (nationwide) Distribution | Details |
| Food/Cosmetics | Atlas Operations, Inc. | Class II | Ongoing | Distributed to one direct account in Florida who further distributed the entire shipment to one account in Dallas, TX. | Details |
| Devices | Helix Medical LLC | Class III | Ongoing | Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Completed | Nationwide distribution: USA including states of: IN, MI, MS, TN and TX. | Details |
| Devices | Siemens Medical Solutions USA, Inc | Class II | Completed | US Nationwide Distribution including the states of: GA, IA, KS, NC and TX. | Details |
| Devices | Medtronic Xomed, Inc. | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom. | Details |
| Devices | Volcano Corporation | Class II | Ongoing | Worldwide Distribution. | Details |
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