Events

Recall of Smith & Nephew Renasys Negative pressure Wound Therapy, canister 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
    18014
  • Event Initiated Date
    2015-03-24
  • 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
    If a blockage in the system isn't recognised, fluid from the wound can build up and leak from the dressing., affected devices may not detect such blockages and will not alarm even if the dressing has visibly lifted from the wound.
  • Action
    Manufacturer to issue advice regarding use

Device

Smith & Nephew Renasys Negative pressure Wound Therapy, canister kit
  • Model / Serial
    Model: Product Code: 66800912, Affected: All lots less than M400300
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc