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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Recall Number Z-1001-2013
Classification Class III
Code Info Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.
Product Distributed Qty 13,749,000
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. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. There is no patient safety risk associated with these products.

Event Detail

Event Id 64585
Product Type Devices
Status Ongoing
Recalling Firm CareFusion 213, LLC
City El Paso
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution