Events

Recall of Z-MED PEDIATRIC/ADULT DILATATION CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NUMED 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
    39364
  • Event Risk Class
    III
  • Event Initiated Date
    2001-12-06
  • 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
    Mislabeling of products. one was rbp labeled at 4atm rather tahn 3atm one was stated a usable length of 85cm rather than 100cm. no risk was involved and the error did not affect product quality.

Device

Z-MED PEDIATRIC/ADULT DILATATION CATHETER
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    162520 Z-MED PED/ADULT DIALATION CATH
  • Manufacturer
    NUMED CANADA INC

Manufacturer

NUMED CANADA INC
  • Manufacturer Address
    CORNWALL
  • Manufacturer Parent Company (2017)
    Numed Canada Inc
  • Source
    HC