Events

Recall of LAERDAL SILICONE RESUSCITATOR - ADULT BASIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LAERDAL MEDICAL CANADA 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
    44449
  • Event Risk Class
    II
  • Event Initiated Date
    2004-01-09
  • 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
    Ambulance arrived on the scene to a patient in cardiac arrest an attempt to resuscitate failed as the resuscitator failed to operate as intended. the patient died.

Device

LAERDAL SILICONE RESUSCITATOR - ADULT BASIC
  • Model / Serial
    Model Catalog: 87 00 55 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 53 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 52 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 51 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 50 (Lot serial: NUMBER 87 54 00.); Model Catalog: 87 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 53 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 52 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 51 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 87 00 50 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 85 00 50 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 85 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 55 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 53 (Lot serial: ALL RESUSCITATORS WITH PART); Model Catalog: 86 00 52 (Lot serial: NUMBER 87 54 00.); Model Catalog: 86 00 51 (Lot serial: NUMBER 87 54 00.); Model Catalog: 86 00 50 (Lot
  • Product Description
    LSR ADULT RESUSCITATOR AND UPGRADE KIT
  • Manufacturer
    LAERDAL MEDICAL CANADA LTD.

Manufacturer

LAERDAL MEDICAL CANADA LTD.