Events

Recall of GIRAFFE WARMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    41524
  • Event Risk Class
    I
  • Event Initiated Date
    2012-10-18
  • 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 oxygen and air wall inlet fittings and/or labels on the back panel were reversed during assembly. as a result this may potentially have reversed air/oxygen mixer concentrations. for example a setting of 100% oxygen could have an output of 21% oxygen and vice versa. the settings of the blender knob will no longer be accurate.

Device

GIRAFFE WARMER
  • Model / Serial
    Model Catalog: GIRAFFE WARMER M1139417 (Lot serial: > 10 numbers contact mfg); Model Catalog: PANDA WARMER M1139612 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    GIRAFFE WARMER WITH Resuscitation Systems with blender
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC