Medical Device Recall: Z-0001-05

FDA Recalls dataset · Firm: DeRoyal Wound Care · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-07-08 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-05.

Recall Res Number
Z-0001-05
Recalling Firm / Manufacturer
DeRoyal Wound Care
FEI Number
1000123222
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-07-08
Date Posted
2004-10-05
Date Terminated
2004-10-05
Product Code
MGQ
Event Number
29815
Product Quantity
4 cases
Product Description 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***
Reason for Recall Wound dressing failed to meet sterility specifications.
Action Details 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.
Distribution Pattern Product was sold to 3 distributors in CA, OH and PA.
Code Information / Serial Numbers Lot 360025

Related Establishments / Registrations

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