Events

Recall of Device Recall ExuDry Wound Dressing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And Nephew, Inc. Wound Management Division.

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
    45901
  • Event Risk Class
    Class 2
  • Event Number
    Z-1217-2008
  • Event Initiated Date
    2007-11-21
  • Event Date Posted
    2008-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69061
  • 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
    Wound Burn Dressing - Product Code MCY
  • Reason
    Sterility (package integrity) compromised: distribution of product that did not meet specifications; open seals.
  • Action
    Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH

Device

Device Recall ExuDry Wound Dressing
  • Model / Serial
    Lot Number 70710
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.
  • Product Description
    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999SJ1, Exu-Dry Small Burn Jacket , Smith & Nephew, Inc.,Largo, Florida.
  • Manufacturer
    Smith And Nephew, Inc. Wound Management Division

Manufacturer

Smith And Nephew, Inc. Wound Management Division
  • Manufacturer Address
    Smith And Nephew, Inc. Wound Management Division, 11775 Starkey Road, Largo FL 33773-4727
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA