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U.S. Department of Health and Human Services

Class 3 Device Recall Sepp

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  Class 3 Device Recall Sepp see related information
Date Initiated by Firm March 04, 2013
Date Posting Updated March 26, 2013
Recall Status1 Terminated 3 on May 12, 2014
Recall Number Z-1001-2013
Recall Event ID 64585
Product Classification Skin prep tray (kit) - Product Code OJU
Product Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk.

Product Usage: Preoperative skin product
Code Information Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.
Recalling Firm/
CareFusion 213, LLC
1550 Northwestern Drive
El Paso TX 79912-8000
For Additional Information Contact Mary Wilson
Manufacturer 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.
FDA Determined
Cause 2
Labeling False and Misleading
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.
Quantity in Commerce 13,749,000
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.