Events

Recall of Vascutek Unsealed PTFE (Maxiflo)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Vascutek 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
    22345
  • Event Initiated Date
    2017-12-08
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The manufacturer has reviewed the ifu contents to ensure consistency across all product families and to ensure that the instructions for use provide state of the art instruction and content to users. as a result of these updates, further clarity will be provided to clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process.
  • Action
    Instructions for use to be updated

Device

Vascutek Unsealed PTFE (Maxiflo)
  • Model / Serial
    Model: , Affected: All Lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd