Events

Recall of Transpac 4 Disposable Pressure Transducer Monitoring Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2017-RN-00015-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00015-1
  • 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
    Certain lots of the transpac 4 disposable pressure transducer monitoring kit may have the potential to leak or potentially introduce small amounts of air into the line. this could result in potential harm to the patient due to blood loss, introduction of air into the line or contamination of intravenous fluid. there is also potential harm to the user as a result of exposure to blood borne pathogens.
  • Action
    Philips is advising users to discontinue use of affected products and to check their inventory for affected stock. Affected stock is to be quarantined and users are requested to contact Philips prior to returning the affected products in order to receive a credit. This action has been closed-out on 01/03/2018.

Device

Transpac 4 Disposable Pressure Transducer Monitoring Kit
  • Model / Serial
    Transpac 4 Disposable Pressure Transducer Monitoring KitProduct Number: 989803177901Lot Numbers: 3239500, 3247905Product Number: 989803194641Lot Number: 3258299ARTG Number: 197576
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA