Events

Recall of FMS Intermediary Tubing with One-Way Valve (used with FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

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
    RC-2013-RN-00949-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00949-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Internal testing has identified that the one-way check valve (pillow valve) included in the fms outflow tubing set and the fms intermediary tubing set may occasionally not be performing as intended. if the instructions described in the fms duo system and solo system operator's manuals are not followed, this may result in backflow of irrigation fluid into the "one day" set, and when used with affected tubing, could potentially lead to patient cross-contamination. please note that the backflow of irrigation fluid can only occur if the check valve is not working properly and the pressure line is disconnected or the tension rocker is open.
  • Action
    Customers are asked to quarantine any affected stock and return it to JJM. Customers are also advised that when connected properly and used in accordance with the system’s Operating Manual, tubing with an affected check valve will not allow backflow of irrigation fluid into the One Day Set, and would not lead to potential patient cross-contamination. It is important to follow up with potentially affected patients per each institution’s Infectious Disease/Needle stick protocol.

Device

FMS Intermediary Tubing with One-Way Valve (used with FMS Fluid Management Systems in a surgical ...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia