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Terminated

Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

FDA Recall Z-1001-2013 · Posted 2013-03-26

Recalling FirmCareFusion 213, LLC
Recall StatusTerminated
Product CodeOJU
Date Initiated2013-03-04
Date Terminated2014-05-12
Product Quantity13,749,000

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.

Firm Action

CareFusion sent an Urgent Recall Notice dated March 4, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, quarantine and return the affected product for replacement. For questions call (913) 345-3504.

Root Cause

Labeling False and Misleading

Distribution Pattern

USA Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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