Recall Z-1001-2013— CareFusion 213, LLC
Class III · Terminated
Class III FDA medical device recall by CareFusion 213, LLC, initiated 2013-03-04, terminated 2014-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product. Reason: 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..
- Recalling firm
- CareFusion 213, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-03-04
- Terminated
- 2014-05-12
- Firm location
- El Paso, TX, United States
Product description
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.