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CareFusion 213, LLC recalls Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Recalled April 3, 2013 · FDA recall Z-1001-2013 · CareFusion 213
Hazard
An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. · FDA Class III
Units
13,749,000
Sold at
USA Nationwide Distribution
Description
An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.
Product
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Manufacturer(s)
CareFusion 213, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →