Events

Recall of Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Swirl Technologies Pty Ltd T/A Parker Healthcare.

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-2017-RN-01060-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01060-1
  • 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 a regular qa inspection, the manufacturer mediplas identified an irregularity in the expandable tubing of specific batches of disposable expandable adult 22mmid expandable anaesthetic circuits. due to this, all remaining unused circuits from the affected batches will be replaced with unaffected product without any additional cost to the customer.
  • Action
    Parker Healthcare is requesting that customers: 1. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact the Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. 2. Complete the Facsimile/Email Reply Form supplied with the customer letter within 5 business days, even if you no longer have affected product, as this information is required to reconcile this process. If any of the recalled products have been transferred to another facility, please immediately let them know of this Recall, and record it on the Facsimile/Email Reply Form.

Device

Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits
  • Model / Serial
    Disposable Expandable Adult 22mmID Expandable Anaesthetic CircuitsPart Numbers:A3E120-700 - 120"/3m Length with Swivel Y AdaptorA3E120-102 - 120"/3m Length with Fixed Y Adaptor and Mask ElbowA3E120-100 - 120"/3m Length with Fixed Y Adaptor A3E240-700 - 240"/6m Length with Swivel Y Adaptor A3E120-702 - 120"/3m Length with Swivel Y Adaptor and Mask ElbowMultiple Batch/Lot NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA