Events

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 ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Wound Care.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29815
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-05
  • Event Initiated Date
    2004-07-08
  • Event Date Posted
    2004-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34578
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic - Product Code MGQ
  • Reason
    Wound dressing failed to meet sterility specifications.
  • 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.

Device

Aquasorb ¿ Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets p...
  • Model / Serial
    Lot 360025
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Product was sold to 3 distributors in CA, OH and PA.
  • 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***
  • Manufacturer
    DeRoyal Wound Care

Manufacturer

DeRoyal Wound Care
  • Manufacturer Address
    DeRoyal Wound Care, Highway 58, PO Box 309, Rose Hill VA 24281-0309
  • Source
    USFDA