Events

Recall of RENASYS-G GAUZE DRESSING KIT WITH SOFT PORT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC..

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
    54351
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Smith & nephew has identified that the process of folding the sterile renasys transparent film pouch during its packaging has the potential to damage the pouch seals resulting in a loss of sterility of the product. the loss of sterility has the potential to contribute to a local infection.

Device

RENASYS-G GAUZE DRESSING KIT WITH SOFT PORT
  • Model / Serial
    Model Catalog: 66800935 (Lot serial: >100 contact mfg); Model Catalog: 66800936 (Lot serial: >100 contact mfg); Model Catalog: 66800933 (Lot serial: >100 contact mfg); Model Catalog: 66800934 (Lot serial: >100 contact mfg); Model Catalog: 66800394 (Lot serial: >100 contact mfg); Model Catalog: 66801256 (Lot serial: >100 contact mfg); Model Catalog: 66800932 (Lot serial: >100 contact mfg); Model Catalog: 66801257 (Lot serial: >100 contact mfg)
  • Product Description
    RENASYS-G GAUZE DRESSING KIT WITH SOFT PORT;RENASYS TRANSPARENT FILM;RENASYS-G GAUZE DRESSING KIT WITH FLAT DRAIN;RENASYS HIGH OUTPUT/FISTULA KIT;RENASYS-G GAUZE DRESSING KIT WITH CHANNEL DRAIN
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.