Events

Recall of Device Recall Multidex Powder

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

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
    28270
  • Event Risk Class
    Class 2
  • Event Number
    Z-0544-04
  • Event Initiated Date
    2004-01-19
  • Event Date Posted
    2004-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31472
  • 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, Hydrophilic - Product Code NAC
  • Reason
    Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
  • Action
    The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.

Device

Device Recall Multidex Powder
  • Model / Serial
    Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015, 106770, 346423, 354811, 387794, 492877, 492906
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Europe
  • Product Description
    Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
  • Manufacturer
    DeRoyal Surgical Tray

Manufacturer

DeRoyal Surgical Tray
  • Manufacturer Address
    DeRoyal Surgical Tray, 1595 Highway 33 S, New Tazewell TN 37825-7105
  • Source
    USFDA