Class 2 Device Recall

• Date Initiated by Firm: July 08, 2004
• Date Posted: October 05, 2004
• Recall Status: Terminated on October 05, 2004
• Recall Number: Z-0001-05
• Recall Event ID: 29815
• Product Classification: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic - Product Code MGQ
• Product: Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
• Code Information: Lot 360025
• FEI Number: 1000123222
• Recalling Firm/ Manufacturer: DeRoyal Wound Care; Highway 58; PO Box 309; Rose Hill VA 24281-0309
• For Additional Information Contact: Gracie Greenway; 865-362-1025
• Manufacturer Reason for Recall: Wound dressing failed to meet sterility specifications.
• FDA Determined Cause: Other
• Action: DeRoyal Wound Care put a hold on remaining lot in inventory pending acceptable dose audit results. The recalling firm notified distributors by phone and letter on 7/8/04 and 7/13/04. The notification advised that the product be segregated to prevent further use and that distributors extend the recall to their consignees if product had been distributed.
• Quantity in Commerce: 4 cases
• Distribution: Product was sold to 3 distributors in CA, OH and PA.
• 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.