Events

Recall of Various Disposable Catheter Mounts

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-01268-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01268-1
  • 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
    Parker healthcare are recalling the affected stock due to a potential obstruction within the swivel elbow adaptor. if component is obstructed, it would restrict the gas flow to the patient and may lead to serious health consequences. two incidents of faulty catheter mounts have been reported. however, to date, no injuries have occurred.
  • Action
    Parker Healthcare are advising users to inspect stock and quarantine any affected units. Affected stock can be returned to Parker for replacement with unaffected product.

Device

Various Disposable Catheter Mounts
  • Model / Serial
    Various Disposable Catheter MountsDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 15MPart Number: 6000-40(D)Disposable Catheter Mount Dble Swvl Elbw w Suction Port & Adaptor 15M SterilePart Number: 6000-40(D)/SDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 22FPart Number: 6000-41(D)Double Swvl Elbw w Suction Port and Cap 15mmM to 22mmM/15mmF Sterile PPPart Number: PH71522/SMultiple Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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