Safety Alert for Warmair Model 134

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cincinnati Sub-Zero.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-10-06
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Health canada type ii recall: warmair model 134 it has come to our attention that the health canada has issued a type ii recall on the cincinnati sub-zero products warmair model 134. the warmair 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. one of the connectors attached to the warmair 134 device's printed circuit board can overheat. this may result in damage to the device's external case and/or melting of some of the internal components. for details, please refer to the following link: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/ recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the product, please contact your supplier or manufacturer for necessary actions or recommendations.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Warmair Model 134
  • Manufacturer

Manufacturer