Events

Recall of PTFE-COATED INFUSION GUIDEWIRE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GYRUS ACMI 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
    79665
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-25
  • 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
    Amplatz ptfe-coated guidewires part number 13bx sold as lot 96158db may have been mis-packaged with product from lot number 96159db. in this case the outer box is labeled with the errant 96158db lot number while the inner pouches are correctly labeled as lot 96159db.

Device

PTFE-COATED INFUSION GUIDEWIRE
  • Model / Serial
    Model Catalog: 13BX (Lot serial: 96158DB)
  • Product Description
    Amplatz PTFE-Coated Guidewire
  • Manufacturer
    GYRUS ACMI INC.

Manufacturer

GYRUS ACMI INC.