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Terminated

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***

FDA Recall Z-0001-05 · Posted 2004-10-05

Recalling FirmDeRoyal Wound Care
Recall StatusTerminated
Product CodeMGQ
Date Initiated2004-07-08
Date Terminated2004-10-05
Product Quantity4 cases

Reason for Recall

Wound dressing failed to meet sterility specifications.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to 3 distributors in CA, OH and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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