FDA Medical Device Recalls (openFDA)
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 number
- Z-0001-05
- Recalling firm
- DeRoyal Wound Care
- 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***
- Status
- Terminated
- Initiated
- 2004-07-08
- Posted
- 2004-10-05
- Terminated
- 2004-10-05
- Reason
- Wound dressing failed to meet sterility specifications.
- Root 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
- 4 cases
- Distribution
- Product was sold to 3 distributors in CA, OH and PA.
- Lot, serial or model codes
- Lot 360025
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MGQ
- Firm FEI
- 1000123222
- Firm city
- Rose Hill
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28