Events

Recall of TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

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-2016-RN-01577-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01577-1
  • 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 investigation of the reported complaints from the field, the manufacturer has identified that there is a potential for some circuits of the affected batch to operate incorrectly. the 10 mmf connector of the circuits was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10 mmm connector under certain pressure and would not deliver the required pressure to the patient.
  • Action
    All remaining TB2000 circuits from the affected Batch TB2000-0141 will be replaced with unaffected batches without any additional costs to the customer. Customers are advised to isolate the affected units and contact Parker Healthcare Customer Service Department or their sales representative to organise the return of the recalled stock and to get replacement stock. This action has been closed-out on 26/05/2017.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Manufacturer

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