Events

Recall of MENTOR SELF-CATH - PVC

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

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
    104497
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-13
  • 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
    Size 16 french self cath catheters were mislabelled. although the catheters were properly labelled as 16fr on their primary packaging the retail box containing the catheters was labelled 10fr. this could lead to an individual using a catheter larger than what is appropriate for his/her anatomy.

Device

MENTOR SELF-CATH - PVC
  • Model / Serial
    Model Catalog: 416 (Lot serial: 2038551)
  • Product Description
    SELF CATH CATHETER-16 FRENCH
  • Manufacturer
    COLOPLAST CANADA CORPORATION

Manufacturer

COLOPLAST CANADA CORPORATION
  • Manufacturer Address
    CONCORD
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    HC