Events

Recall of TRANSWARMER INFANT TRANSPORT MATTRESS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL 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
    44693
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-15
  • 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
    Coopersurgical has advised the importer that all transwarmer mattress users must review their inventory and discard or return to coopersurgical any product that does not display a product lot code or expiration date on the individual unit. serious burns have been reported in the past and could occur if the products are not stored under labeled conditions or are used beyond the recommended shelf life.

Device

TRANSWARMER INFANT TRANSPORT MATTRESS

Manufacturer

ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD.
  • Manufacturer Address
    DORVAL
  • Source
    HC