Class 2 Device Recall Multidex Powder

• Date Initiated by Firm: January 19, 2004
• Date Posted: February 24, 2004
• Recall Status: Terminated on October 13, 2004
• Recall Number: Z-0544-04
• Recall Event ID: 28270
• 510(K)Number: K945000
• Product Classification: Dressing, Wound, Hydrophilic - Product Code NAC
• Product: Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
• Code Information: Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015, 106770, 346423, 354811, 387794, 492877, 492906
• FEI Number: 3003040625
• Recalling Firm/ Manufacturer: DeRoyal Surgical Tray; 1595 Highway 33 S; New Tazewell TN 37825-7105
• For Additional Information Contact: Mr. Tracy Edmundson; 865-362-2334
• Manufacturer Reason for Recall: Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
• FDA Determined Cause: Other
• Action: The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.
• Quantity in Commerce: 2,495 units
• Distribution: Nationwide and Europe
• 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.

• 510(K) Database: 510(K)s with Product Code = NAC