Events

Recall of NON-STERILE STEP DOWN CONNECTOR

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

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
    121020
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-05
  • 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
    Integra lifesciences corporation (integra) has recently become aware that the current packaging configuration for the non-sterile step down connector may lead to a potentially conflicting message regarding product sterility. this individually sold non-sterile stepdown connector is packaged with a label that correctly states the product is non-sterile and also with instructions for use (ifu) from the sterile kit with which it is designed to be used as a reference to the customers. although the accessories are marked on the external label as non-sterile the ifu which is visible through the packaging states that the related shunt kit is sterile. this may lead to confusion as to whether these non-sterile products are sterile.

Device

NON-STERILE STEP DOWN CONNECTOR
  • Model / Serial
    Model Catalog: NL8600401 (Lot serial: )
  • Product Description
    NON-STERILE STEP DOWN CONNECTOR
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.