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
    48164
  • 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
    Loosened nut led to the falling off of a wheel from the castor due the flat m8 nut and locking compound. therefore a modification has been performed on all iw930 and iw950 cosycat infant radiant warmers.

Device

INFANT RADIANT WARMERS
  • Model / Serial
    Model Catalog: IW950 (Lot serial: 665040015); Model Catalog: IW930 (Lot serial: 665040015); Model Catalog: IW950 (Lot serial: 043041121 - 043041239); Model Catalog: IW930 (Lot serial: 043041121 - 043041239); Model Catalog: IW950 (Lot serial: IW950xxx); Model Catalog: IW930 (Lot serial: IW950xxx); Model Catalog: IW950 (Lot serial: IW930xxx); Model Catalog: IW930 (Lot serial: IW930xxx)
  • Product Description
    Twin Castors on IW930 &IW950 Warmers
  • Manufacturer
    BENSON MEDICAL INDUSTRIES INC.

Manufacturer

BENSON MEDICAL INDUSTRIES INC.