Events

Recall of Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

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
    RC-2016-RN-01065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01065-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Smith & nephew have identified seal integrity failures on the folded sterile renasys transparent film pouches during transit testing. all the seal integrity failures identified during the testing occurred at the point where the sterile renasys transparent film pouches were folded during the packaging process.The loss of sterility has the potential to contribute to a local infection. to date, smith & nephew is not aware of any complaints reported in relation to this issue that has led to a local infection.
  • Action
    Smith & Nephew are advising users to inspect stock and quarantine all affected units. In the event that a Transparent Film is required for NPWT therapy, the responsible Health Care Professional should be consulted to determine an alternative Transparent Film or alternative treatment. Affected stock can be returned and replaced with unaffected product.

Device

Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds ...
  • Model / Serial
    Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))Part Numbers: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258Multiple Products and Lot Numbers affectedARTG Number: 149671
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd