Events

Recall of STAT 2 PRIMARY SET

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

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
    74846
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-19
  • 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
    Conmed determined that certain devices were assembled with an incorrectly-dimensioned supplier component which may cause the device to exhibit inaccurate or inconsistent flow rates. if the device is unable to regulate flow as set and confirmed by the attending medical staff and the delivery of essential medications or treatment is dependent on the device's function this may result in possible injury to the patient.

Device

STAT 2 PRIMARY SET
  • Model / Serial
    Model Catalog: S2V-60 N (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S2V-20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S2V-20 N (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S2V-60 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S2-12 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S2-12 N (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    STAT 2 PRIMARY ADMINISTRATION SET GRAVITY FLOW CONTROLLER;STAT 2 EXTENSION SET GRAVITY FLOW CONTROLLER
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC