Events

Recall of CRYOSURGERY SYSTEM LM-900

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERSURGICAL 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
    32351
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-30
  • 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 recently completed validation of a new disinfection procedure and the instructions for use (ifu) for the affected products have been updated. copies of the updated ifu are being sent to end users. additionally coopersurgical has determined that the useful life of the affected products is 5 years based on a 650 maximum reprocessing cycles.

Device

CRYOSURGERY SYSTEM LM-900
  • Model / Serial
    Model Catalog: 50502 (Lot serial: All lots); Model Catalog: 50501 (Lot serial: All lots); Model Catalog: 2400 (Lot serial: All lots); Model Catalog: 2402 (Lot serial: All lots); Model Catalog: 2401 (Lot serial: All lots)
  • Product Description
    Cryosurgery System LM-900;Frigitronics Cryo-Plus Cryosurgery System
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.