Events

Recall of NAMIC CONVENIENCE KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NAVILYST 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
    83818
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-22
  • 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
    Navilyst medical has determined that the labelled expiration dating of the affected product is not fully supported by shelf life verification testing which may result in a sterility breach. use of a fluid management convenience kit where sterility has been breached may result in an increased risk of infection.

Device

NAMIC CONVENIENCE KIT
  • Model / Serial
    Model Catalog: H965607011741 (Lot serial: >10 lot #contact manufacturer)
  • Product Description
    NAMIC Convenience kit
  • Manufacturer
    NAVILYST MEDICAL INC.

Manufacturer

NAVILYST MEDICAL INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    HC