Events

Recall of PRONTO-SHORT EXTRACTION CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER V MEDICAL 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
    23563
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-30
  • 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
    The exp. date of the sterile pouched guidewire was not considered when exp. dating was calculated for the finished device. cannot assure sterility or function of the guidewire beyond its exp date.

Device

PRONTO-SHORT EXTRACTION CATHETER
  • Model / Serial
    Model Catalog: (Lot serial: LOT 544202 EXP 11-2009); Model Catalog: (Lot serial: LOT 546614 EXP 09-2010); Model Catalog: (Lot serial: LOT 545693 EXP 05-2010)
  • Product Description
    PRONTO SHORT EXTRACTION CATHETER
  • Manufacturer
    INTER V MEDICAL INC.

Manufacturer

INTER V MEDICAL INC.
  • Manufacturer Address
    MONTREAL
  • Source
    HC