Events

Recall of RENASYS-G GAUZE DRESSING KIT WITH FLAT DRAIN

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
    63134
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-20
  • 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
    It has been determined that the wipes in the kits subject to this correction were made in the same facility as other wipe products including wipes swabs and swab sticks that are the subject of other voluntary recalls due to a potential bacterial contamination issue.

Device

RENASYS-G GAUZE DRESSING KIT WITH FLAT DRAIN
  • Model / Serial
    Model Catalog: 66800492 (Lot serial: 30310H); Model Catalog: 66800494 (Lot serial: 30310H); Model Catalog: 66800492 (Lot serial: 35510H); Model Catalog: 66800494 (Lot serial: 35510H); Model Catalog: 66800492 (Lot serial: 10310N); Model Catalog: 66800494 (Lot serial: 10310N); Model Catalog: 66800492 (Lot serial: 11410E); Model Catalog: 66800494 (Lot serial: 11410E); Model Catalog: 66800492 (Lot serial: 00811N); Model Catalog: 66800494 (Lot serial: 00811N); Model Catalog: 66800494 (Lot serial: 09510N); Model Catalog: 66800492 (Lot serial: 09510N); Model Catalog: 66800493 (Lot serial: 00811K); Model Catalog: 66800493 (Lot serial: 09510U); Model Catalog: 66800493 (Lot serial: 27210D); Model Catalog: 66800493 (Lot serial: 27710W); Model Catalog: 66800493 (Lot serial: 28410H); Model Catalog: 66800493 (Lot serial: 29210F); Model Catalog: 66800493 (Lot serial: 29210P); Model Catalog: 66800495 (Lot serial: 27810D); Model Catalog: 66800491 (Lot serial: 27810D); Model Catalog: 66800496 (Lot serial: 21010E); Model Catal
  • Product Description
    RENASYS G GAUZE DRESSING KIT
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.