Events

Recall of Teleflex Medical RTP - Valve, non-rebreathing

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Teleflex Medical 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
    22833
  • Event Initiated Date
    2018-04-19
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • Reason
    The manufacturer has indentified that the hudson rci one-way valve with capped may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.
  • Action
    Product to be returned to supplier

Device

Teleflex Medical RTP - Valve, non-rebreathing
  • Model / Serial
    Model: , Affected: Affected lot numbers 74D1501706, 74K1502092, 74F1600367, 74J1600117, 74L1601916, 74C1701733, 74F1700707, 74D1501731, 74K1502045, 74F1601072, 74J1601101, 74M1600284, 74C1702365, 74F1701866
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc