Events

Recall of INFANT RADIANT WARMERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BENSON MEDICAL INDUSTRIES 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
    49927
  • Event Risk Class
    II
  • Event Initiated Date
    2002-05-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The grill of the cosycat infant warmer openned due to a fractured internal screww boss. no patient injury was reported however field upgrade will be conducted in order to avoid future occurrences.

Device

INFANT RADIANT WARMERS
  • Model / Serial
    Model Catalog: IW980 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW970 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW960 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW950 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW930 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW920 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW910 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW990 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW980 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW990 (Lot serial: PW800 Series Patient Warmers); Model Catalog: IW910 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW920 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW930 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW950 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW960 (Lot serial: IW900 Series Infant Warmers); Model Catalog: IW970 (Lot serial: IW900 Series Infant W
  • Product Description
    Infant Radiant and Patient Warmers
  • Manufacturer
    BENSON MEDICAL INDUSTRIES INC.

Manufacturer

BENSON MEDICAL INDUSTRIES INC.