Events

Recall of Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Kabi 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-2018-RN-00053-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00053-1
  • 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
    Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
  • Action
    Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.

Device

Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Sp...
  • Model / Serial
    Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILEMultiple Affected Part and Lot NumbersARTG Number: 225965 (Fresenius Kabi Australia Pty Limited - Infusion administration set, infusion pump)
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd