Events

Recall of OPTILITE HOLMIUM FIBER ASSEMBLY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (CANADA) 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
    21457
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-04
  • 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
    Three units provided to customer with incorrect manufacturer and part number information shown on label. part number provided was hlf-m940-cnv and shows cook urological as the manufacturer (displays "manufactured for:" and is intended for us distribution only). canadian customers should be directed to order identical part number hlf-m940-cnv-can which shows proper manufacturer information for canada.

Device

OPTILITE HOLMIUM FIBER ASSEMBLY
  • Model / Serial
    Model Catalog: HLF-M940-CNV-CAN (Lot serial: U2116722)
  • Product Description
    OPTILITE multi-use HOLMIUM laser FIBER
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.