Recall of Cincinnati Sub-Zero WarmAir Convection Warming Device

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cincinnati Sub Zero Products 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
    11248
  • Event Initiated Date
    2012-11-06
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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 manufacturer, cincinnati sub-zero has made changes to the warmair@ model 135 convective warming devices operation & technical manual to stay in compliance with fda labelling regulations.
  • Action
    Instructions for use to be updated

Device

Manufacturer