Events

Recall of Parker Medical Flex-Tip endotracheal tube

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Well Lead Medical Co 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
    13568
  • Event Initiated Date
    2012-10-03
  • 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
    Several reports that the cuffs of parker medical tubes with the lot number 1107021643 lacked the ability to be properly inflated or to maintain pressure after inflation. there are no reports of patient injury. parker medical is concerned with the potential for injury due to the inability of the cuffs on these tubes to be properly inflated or to maintain their pressure after inflation.
  • Action
    Product to be returned to supplier

Device

Parker Medical Flex-Tip endotracheal tube
  • Model / Serial
    Model: Lot No; 1107071643, Affected: I-PFHV -70, I-PFHV-75 and I-PFHV-80
  • Manufacturer
    Well Lead Medical Co Ltd

Manufacturer

Well Lead Medical Co Ltd