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-2017-RN-00490-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00490-1
  • 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 an investigation of the reported customer complaints, the manufacturer has identified that there is a potential for some circuits of the affected batches to operate incorrectly. the 10mm female connector was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10mm male connector under certain conditions and would therefore not deliver the required pressure to the patient.
  • Action
    Affected Lots are being recalled from Hospitals. Users are requested to note this is an expanded recall from December 2016 where this issue was first identified and Batch Number: TB2000-0141 was recalled.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP
  • Model / Serial
    TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEPThis Recall:- Batch / Lot Number: TB2000-0146, TB2000-0149 and TB2000-0151Previous Recall from December 2016:- Batch / Lot Number: TB2000-0141ARTG Number: 188097
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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