FDA-Device2013-04-03Class III
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
CareFusion 213, LLC
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.
Sold states
USA Nationwide Distribution
Affected count
13,749,000
Manufactured in
1550 Northwestern Drive, El Paso, TX, United States
Products
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2013Don't want to check this manually?
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