Events

Recall of LAPSAC INTRODUCER

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
    56454
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-01
  • 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
    Notice advising users of updates to the ifu for the lapsac surgical tissue pouch to remove morcellation from the intended use warnings and the instructions for use and to add a contraindication. this communication is for informational purposes only and no devices need to be returned. it is intended that all future devices will include the updated ifu. sales of the device have been suspended until the new ifu can be included with the device.

Device

LAPSAC INTRODUCER
  • Model / Serial
    Model Catalog: (Lot serial: ALL)
  • Product Description
    LAPSAC INTRODUCER
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.