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U.S. Department of Health and Human Services

Class 3 Device Recall Sepp

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 Class 3 Recall
Sepp
see related information
Date Posted March 26, 2013
Recall Status1 Terminated 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/
Manufacturer
CareFusion 213, LLC
1550 Northwestern Drive
El Paso, Texas 79912-8000
For Additional Information Contact Mary Wilson
915-231-5000
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
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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