Date Initiated by Firm | March 04, 2013 |
Date Posted | 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
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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 TX 79912-8000
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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 | 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 |
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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.
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