Z-0001-05

Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case...

Name: Z-0001-05 Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case...
Creator: DeRoyal Wound Care
Published: 2004-07-08
License: https://open.fda.gov/license/

DeRoyal Wound Care / initiated 2004-07-08 / Terminated / root cause: sterility

FDA source

DeRoyal Wound Care began a recall of 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... on 2004-07-08. The reason FDA records is "Wound dressing failed to meet sterility specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0001-05
Status: Terminated
Initiated: 2004-07-08
Posted: 2004-10-05
Terminated: 2004-10-05
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***
Product code: MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall: Wound dressing failed to meet sterility specifications.
Root cause tag: sterility
FDA 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 in commerce: 4 cases
Distribution: Product was sold to 3 distributors in CA, OH and PA.
Product codes and lots: Lot 360025

Product code MGQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)