Enforcement Report - Week of December 5, 2012
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| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Illinois | Details |
| Biologics | Mississippi Valley Reg Bld Ctr | Class II | Terminated | Illinois; Iowa; Switzerland | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class III | Terminated | CA | Details |
| Biologics | BioLife Plasma Services L.P. | Class II | Terminated | CA | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | Illinois; Germany; Switzerland | Details |
| Biologics | CSL Plasma, Inc. | Class II | Terminated | Illinois; North Carolina; Germany; Switzerland | Details |
| Devices | First Medical Source LLC | Class I | Terminated | US Nationwide distribution in the state of IL | Details |
| Food/Cosmetics | Quality Dairy Farms Inc. | Class II | Terminated | Upstate New York | Details |
| Devices | Extremity Medical LLC | Class II | Ongoing | Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland. | Details |
| Biologics | Florida Blood Services, Inc. | Class III | Terminated | Florida | Details |
| Biologics | BloodSource, Inc. | Class II | Terminated | California | Details |
| Biologics | LifeShare Blood Centers | Class III | Terminated | Switzerland | 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 | New York Blood Center, Inc. | Class II | Terminated | New York | Details |
| Biologics | Belle Bonfils Memorial Blood Center | Class II | Terminated | Pennsylvania; Colorado | Details |
| Drugs | Samantha Lynn, Inc | Class I | Ongoing | Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II | Terminated | Florida | Details |
| Biologics | Community Blood Centers of South Florida, Inc. | Class II | Terminated | Florida; New York | Details |
| Biologics | Michigan Blood | Class II | Terminated | Michigan | Details |
| Devices | GE Healthcare, LLC | Class II | Ongoing | Nationwide distribution | Details |
| Devices | Parks Medical Electronics, Inc | Class II | Ongoing | Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela. | Details |
| Devices | Diamedix Corporation | Class II | Ongoing | Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador | Details |
| Food/Cosmetics | Nestle Professional | Class II | Ongoing | Distributed to CA. | Details |
| Food/Cosmetics | Gasco Industrial | Class II | Ongoing | PR only | Details |
| Food/Cosmetics | BumbleBar, Inc. | Class I | Ongoing | Products are distributed nationwide and Hong Kong | Details |
| Devices | Terumo Cardiovascular Systems Corporation | Class II | Ongoing | Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. | Details |
| Devices | Zimmer, Inc. | Class II | Ongoing | Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden, | Details |
| Devices | Metrex Research, LLC. | Class II | Terminated | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. | Details |
| Food/Cosmetics | Wm Bolthouse Farms Inc | Class I | Ongoing | US and Canada | Details |
| Food/Cosmetics | CSM Bakery Products NA | Class I | Ongoing | New York, New Jersey, Massachusetts, Illinois, Ohio, and Ontario, Canada | Details |
| Drugs | Boehringer Ingelheim Roxane Inc | Class II | Ongoing | Nationwide | Details |
| Devices | Kimberly-Clark Corporation | Class II | Completed | Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI | Details |
| Drugs | Procter & Gamble Co | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Hillshire Brands Company | Class I | Ongoing | Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia | Details |
| Food/Cosmetics | Nestle USA | Class I | Ongoing | Nationwide in the US | Details |
| Food/Cosmetics | Kroger Co | Class I | Ongoing | Product was shipped to the following states: AZ, CO, ID, KS, MO, MT, NE, NM, NV,UT & WY. | Details |
| Devices | Iradimed Corporation | Class II | Ongoing | Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX. | Details |
| Devices | Cooper Surgical, Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan. | Details |
| Drugs | GlaxoSmithKline, LLC. | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | Tri-Union Seafoods, L.L.C dba Chicken of the Sea. | Class I | Ongoing | Nationwide in the US: TX, IL, UT, WA, CA, AZ. | Details |
| Drugs | GlaxoSmithKline, LLC. | Class III | Ongoing | Nationwide and Puerto Rico. | Details |
| Devices | Biomet, Inc. | Class II | Ongoing | Nationwide distribution: USA including states of: AZ, MD, and KS. | Details |
| Food/Cosmetics | Ernimich, Inc. (dba Nina International, Inc.) | Class I | Ongoing | The products were sold in Virginia, Maryland and Washington, D.C. | Details |
| Devices | Medtronic Navigation, Inc. | Class II | Ongoing | Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea. | Details |
| Food/Cosmetics | Whole Foods Market South Seafood Distribution | Class I | Ongoing | AL, GA, NC, SC and TN. | Details |
| Food/Cosmetics | United Dairy Farmers Inc | Class I | Ongoing | Ohio, Inidania, Kentucky, and Michigan | Details |
| Drugs | Ranbaxy Inc. | Class II | Ongoing | Nationwide and PR | Details |
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