Events

Recall of Hsiner_Manual Resuscitator (Disposable)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hsiner 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
    20998
  • Event Initiated Date
    2017-01-10
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    The manufacturer has identified the possibility of a functional failure on the pop-off valve assembled on the disposable manual resuscitator. the valve may have a dimension issue, resulting in the valve being unable to fully close off when the patient needs higher pressure (40cm h2o and above).
  • Action
    Product to be returned to supplier

Device

Hsiner_Manual Resuscitator (Disposable)
  • Model / Serial
    Model: , Affected: Product Code: HS-60122 and HS-60123. Batch/Lot/Serial numbers: 20160926019, 20160926020, 20161108023 and 20161108066
  • Manufacturer
    Hsiner Co Ltd

Manufacturer

Hsiner Co Ltd