Events

Recall of A3/A5 Anesthesia Delivery System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ulco Engineering 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-2012-RN-01161-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01161-1
  • 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
    There is the possibility of a system leak resulting from improper seating of the co2 absorbent canister gasket. should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked, and locked again to reseat the gasket. if the co2 absorbent gasket is improperly seated, however a potential leak will likely present itself during the automatic circuit leak and compliance test performed at startup and the manual leak test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.This recall action was not notified to the tga before it was initiated by ulco medical.
  • Action
    Ulco Medical is providing work around instructions and will be replacing the canister gasket to permanently correct the issue.

Device

A3/A5 Anesthesia Delivery System

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA