Events

Recall of Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Galemed Corporation.

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
    18809
  • Event Initiated Date
    2015-07-08
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Reason
    The oxygen intake port may be blocked which can prevent the bag from filling. this may prevent the device from delivering breathing support to the patient. a delay in treatment may potentially lead to patient injury or death. to date, teleflex has not received any reports of patient injury or death related to this issue.
  • Action
    Product to be returned to supplier

Device

Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator

Manufacturer

Galemed Corporation