Events

Recall of Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Swivel Elbow

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-01168-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01168-1
  • 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, parker healthcare noticed an irregularity in the expandable tubing of specific tube/mask breathing circuit single-use connectors (disposable catheter mounts). to date, no injury or illness has been reported.
  • Action
    1. Complete and return the supplied acknowledgement form. If any of the affected products have been transferred from your facility to another, immediately inform other supplied facilities of this Recall. 2. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact 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. Returned stock will be replaced with unaffected batches at no cost.

Device

Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Sw...
  • Model / Serial
    Various Disposable Catheter MountsStraight SwivelSwivel ElbowStraight AdaptorsElbowDouble Swivel ElbowMultiple Product Names, Part Numbers and Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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