Events

Recall of ZOLL ProPadz Sterile Multi-Function Electrodes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zoll Medical Australia Pty Ltd.

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-2014-RN-00949-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-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
    During internal sterility testing zoll medical corporation has determined that the zoll propadz sterile multi-function electrodes from the lot listed may not be sterile.
  • Action
    Zoll Medical Australia is requesting their customer to quarantine all affected stock. Arrangements will be made for the recovery of the devices. This action has been closed-out on 1/06/2016.

Device

ZOLL ProPadz Sterile Multi-Function Electrodes
  • Model / Serial
    ZOLL ProPadz Sterile Multi-Function ElectrodesProduct code 8900-4055-40 and 8900-4052-40 Lot Number: 2314 & 1914ARTG Number: 218497
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd