DeRoyal Wound Care 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*** Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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***
Brand
DeRoyal Wound Care
Lot Codes / Batch Numbers
Lot 360025
Products Sold
Lot 360025
DeRoyal Wound Care is recalling Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per c due to Wound dressing failed to meet sterility specifications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Wound dressing failed to meet sterility specifications.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, OH, PA
Page updated: Jan 10, 2026