Reported Apr 3, 2013 · Terminated
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
CareFusion 213, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 213, LLC · 1550 Northwestern Drive · El Paso, TX · 79912-8000
Is this the product you have?
- Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk
- Product UsagePreoperative skin product
- Lot codes and dates
- Tincture Packaged
Product Number 260619 and Product ID D086353Tincture 3000
- BulkProduct Number 260520 and Product ID D086353
- Tincture Packaged
- Amount recalled
- 13,749,000
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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