Events

Recall of Smith & Nephew Renasys Transparent Film and Renasys Gauze Dressing Kits NPWT Wound Sealing Kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    20501
  • Event Initiated Date
    2016-08-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Smith & Nephew Ltd, Unit A, 36 Hillside Rd, Wairau Walley, Auckland 0627
  • Reason
    The manufacturer has 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.
  • Action
    Product to be returned to supplier

Device

Smith & Nephew Renasys Transparent Film and Renasys Gauze Dressing Kits NPWT Wound Sealing Kit
  • Model / Serial
    Model: , Affected: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc