Events

Recall of CRW SYSTEM - INTUBATION HEAD RING KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRA CANADA ULC..

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
    132547
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-13
  • 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 recall is to inform affected customers of a possible interference between the t-handle on the hraim and the crw arc system and rework affected hraim devices by providing a new design hrimtsc t handle screw.

Device

CRW SYSTEM - INTUBATION HEAD RING KIT
  • Model / Serial
    Model Catalog: HRAIM (Lot serial: ALL LOTS); Model Catalog: HRIMTS (Lot serial: ALL LOTS); Model Catalog: CRW-ASL (Lot serial: ALL LOT)
  • Product Description
    CRW SYSTEM - INTUBATION HEAD RING KIT
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.