Enforcement Report - Week of November 14, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Devices | Sechrist Industries Inc | Class II | Terminated | Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada | Details |
| Devices | Medacta Usa Inc | Class II | Completed | Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium. | Details |
| Drugs | Aurobindo Pharma LTD | Class II | Ongoing | Nationwide | Details |
| Devices | Shimadzu Medical Systems | Class II | Ongoing | US Nationwide Distribution | Details |
| Devices | Sysmex America, Inc. | Class II | Ongoing | Nationwide distribution: USA including Puerto Rico. | Details |
| Veterinary | Land O Lakes Purina LLC | Class I | Ongoing | WI Expanded Recall: AL, AR, CA, CO,FL, GA, IA, IL, IN, KY, KS, MS, MI, MN, MO, NC, NE, NY, NM, OR, OH, OK, PA , SC, SD, TN, TX, WI. | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Pennsylvania; Florida; New York | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Central Jersey Blood Center, Inc. | Class II | Terminated | New Jersey | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Hoxworth Blood Center UC Medical Center | Class II | Terminated | Ohio | Details |
| Biologics | The American National Red Cross - Southern Region | Class III | Terminated | California | Details |
| Biologics | Mississippi Blood Services Inc. | Class II | Terminated | Mississippi | Details |
| Devices | Siemens Healthcare Diagnostics, Inc. | Class III | Ongoing | USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI. | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | 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 | Walter L. Shepeard Community Blood Center, Inc. | Class II | Terminated | Georgia | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II,Class III | Terminated | Florida; New Zealand | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II,Class III | Terminated | Switzerland; Florida | Details |
| Biologics | Florida's Blood Centers, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II | Completed | Florida; New York | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Iowa; New Jersey | Details |
| Biologics | Blood Systems Inc | Class II | Terminated | Arizona | Details |
| Biologics | Suncoast Communities Blood Bank, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class III | Terminated | Missouri | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | Minnesota | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | Switzerland; Minnesota | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | Minnesota | Details |
| Biologics | Interstate Blood Bank, Inc. of Wisconsin | Class II | Terminated | California; Germany, Federal Republic of | Details |
| Biologics | Interstate Blood Bank, Inc. of Wisconsin | Class II | Terminated | California | Details |
| Biologics | Carter BloodCare | Class II,Class III | Terminated | Austria; Texas | Details |
| Biologics | Blood Assurance Inc | Class III | Terminated | Tennessee | Details |
| Devices | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Class II | Ongoing | Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand | Details |
| Biologics | LifeShare Blood Centers | Class II | Terminated | Switzerland | Details |
| Biologics | ITXM Clinical Services | Class III | Terminated | Pennsylvania | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II,Class III | Terminated | Florida; New Zealand | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Community Blood Centers of Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II,Class III | Terminated | Florida; New Zealand | Details |
| Food/Cosmetics | Giant Eagle | Class I | Ongoing | Product was distributed within the US to select supermarkets (not under the Giant Eagle banner) in OH AND PA. | Details |
| Devices | Primus Medical LLC | Class II | Ongoing | Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA. | Details |
| Devices | Clinical Diagnostic Solutions | Class III | Ongoing | Nationwide Distribution. | Details |
| Devices | Clinical Diagnostic Solutions | Class III | Ongoing | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia | Details |
| Devices | Zimmer, Inc. | Class II | Ongoing | Nationwide Distribution. | Details |
| Food/Cosmetics | Fabrica Confecciones Soto, Inc. | Class II | Ongoing | PR only. Product sold by the firm at retail. | Details |
| Devices | Diagnostica Stago, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and Canada | Details |
| Devices | Stryker Howmedica Osteonics Corp. | Class II | Ongoing | Nationwide Distribution. | Details |
| Food/Cosmetics | Fresh Express Incorporated | Class I | Ongoing | AZ, CA, CO, ID, MD, MN, MT, OR, TX, WA and Canada. | Details |
| Food/Cosmetics | FreshPoint Central Florida | Class I | Ongoing | Florida | Details |
| Devices | Kerr Corporation | Class II | Completed | Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia. | Details |
| Devices | Abbott Point Of Care Inc. | Class III | Ongoing | Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy. | Details |
| Food/Cosmetics | Kellogg Company | Class II | Ongoing | US, nationwide and Canada | Details |
| Food/Cosmetics | Jamba Juice | Class I | Ongoing | Products were released for distribution in US. | Details |
| Devices | Sendx Medical Inc | Class II | Terminated | Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic. | Details |
| Devices | Sunquest Information Systems, Inc. | Class II | Terminated | Worldwide Distribution - USA (nationwide) and Internationally to Ireland | Details |
| Devices | Sunquest Information Systems, Inc. | Class II | Terminated | Nationwide Distribution. | Details |
| Devices | Sorin Group USA, Inc. | Class II | Ongoing | Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom. | Details |
| Devices | OrthoPediatrics Corp | Class II | Ongoing | Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA. | Details |
| Food/Cosmetics | Clemmy's LLC | Class I | Ongoing | US States: CA, WA, NC, DE, HI, MN, OH, NH, NY, and IL. No international distribution. | Details |
| Food/Cosmetics | Belfonte Ice Cream & Dairy Foods Co | Class I | Ongoing | The products were distributed in MO, KS, OK, AR | Details |
| Devices | Ormco/Sybronendo | Class II | Terminated | Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique. | Details |
| Food/Cosmetics | Bliss Unlimited | Class I | Ongoing | Product was distributed to California, Illinois, New Hampshire, New York, Washington, and Wisconsin. | Details |
| Devices | Philips Medical Systems (Cleveland), Inc. | Class II | Ongoing | Nationwide distribution: USA including states of: ME, MI, NY, and WI. | Details |
| Food/Cosmetics | Danielle Livolsi Jagrma | Class I | Ongoing | CA & NH | Details |
| Food/Cosmetics | PureFit Inc | Class I | Ongoing | Nationwide in the US and worldwide: Australia, Canada, Norway, New Zealand, Ireland, Italy, and United Kingdom. | Details |
| Food/Cosmetics | Flying Food Group, Inc. | Class I | Ongoing | CT, MA, NY, NJ, PA, DE, MD, DC, VA, GA, FL, IL, WI, MN, IN, TX, AZ, NV, and CA | Details |
| Food/Cosmetics | Hannaford Bros. | Class I | Terminated | New York, Maine, New Hampshire, Massachusetts and Vermont | Details |
| Food/Cosmetics | S & P Company Limited | Class I | Ongoing | US states: AZ, CA, IL, NE, and TX. No international distribution. | Details |
| Food/Cosmetics | Pennsylvania State University Berkey Creamery | Class II | Ongoing | On site retail salesroom and internet customers | Details |
| Food/Cosmetics | Mondelez Global Llc | Class I | Ongoing | Nationwide. | Details |
| Food/Cosmetics | Creative Energy Foods, Inc. LLC | Class I | Ongoing | Product was only sold on the internet. | Details |
| Food/Cosmetics | Velvet Ice Cream Company | Class I | Ongoing | IN, KY, OH, and WV | Details |
| Food/Cosmetics | Turkey Hill Dairy, Inc. | Class II | Ongoing | Product was distributed to one retail chain and 3 independent grocers in the State of Pennsylvania. | Details |
| Food/Cosmetics | Think Thin, LLC | Class I | Ongoing | US states nationwide. No international distribution. | Details |
| Food/Cosmetics | Dole Fresh Vegetables Inc | Class I | Ongoing | IL, IN, ME,. MO, NJ, NY, OH, PA, TN and WI | Details |
| Food/Cosmetics | Natural Selection Foods LLC dba Earthbound Farm | Class I | Ongoing | CA, FL, HI, LA, MA, MT, NE, NJ, NY, OH, OR, PA, TX and Canada | Details |
| Food/Cosmetics | Energy Club Inc | Class I | Ongoing | nationwide in the US | Details |
| Drugs | Valeant Pharmaceuticals | Class III | Ongoing | Nationwide | Details |
| Food/Cosmetics | The Nut Factory Inc. | Class I | Ongoing | Product was distributed in Washington state. There are no Canadian consignees. | Details |
| Devices | Spacelabs Healthcare, Llc | Class II | Ongoing | Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom | Details |
| Food/Cosmetics | Honolulu Baking Company, Ltd. | Class I | Terminated | HI distribution only on island of Oahu. | Details |
| Food/Cosmetics | Southern Belle, Inc. | Class I | Ongoing | TN | Details |
| Devices | American Medical Systems, Inc. | Class II | Ongoing | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan. | Details |
| Food/Cosmetics | Williams and Company Inc dba The Nut Shop | Class I | Completed | AL and MS | Details |
| Devices | Kimberly-Clark Corporation | Class II | Ongoing | Nationwide Distribution | Details |
| Devices | Alphatec Spine, Inc. | Class II | Completed | Nationwide Distribution including TN, WI, and FL. | Details |
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