Events

Recall of Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien 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-01130-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01130-1
  • 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
    Covidien pty ltd (covidien), following advice from the therapeutic goods administration and the manufacturer marck biosciences ltd (now known as amanta healthcare ltd) that batch number 1t2324002 of the below product has failed the test for sterility, is recalling this batch at the retail level. please note that there have been no adverse events reported regarding this sterility test failure.
  • Action
    Covidien is requesting the customers to identify and quarantine the affected stock. Covidien will arrange for shipment pickup from the distribution centre and will provide credit note for the returned stock. This action has been closed-out on 05/12/2016.

Device

Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule
  • Model / Serial
    Gelflex Sterile Eye Wash Normal Saline 10mL AmpouleProduct code: 8200Batch number: 1T2324002Expiry Date: December 2017ARTG Number: 151536
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA