Events

Recall of Use of Tristel Trio Wipes System with GE TEE probe

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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-2018-RN-00114-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00114-1
  • 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
    The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans. further testing has identified a need for clarification of the previously communicated disinfection guidance for ge tee probes regarding use of the tristel trio wipes system. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods using tristel trio wipes may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. ge recommends the additional use of a sterile sheath covering the tee probe when tristel trio wipes are being used as the sole method of disinfection.
  • Action
    Under conditions where the TEE probe has a long intubation time or shows visible signs of wear and damage, GE recommends the use of a sterile sheath covering the TEE probe in addition to disinfection using the Tristel Trio Wipes System.

Device

Use of Tristel Trio Wipes System with GE TEE probe
  • Model / Serial
    Use of Tristel Trio Wipes System with GE TEE probeAffected Product: TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RSMultiple affected probe types and part numbersARTG Number:123916(GE Medical Systems Australia - Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd