Events

Recall of Edwards Pressure Monitoring Kit & Set

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Edwards Lifesciences 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-2015-RN-00772-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00772-1
  • 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
    A flow restriction issue has been identified in a trifurcated iv set included in the pressure transducer kits. a restriction of the flow of iv fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. in either instance, the tubing can be exchanged for a new set. this may result in a procedural delay.
  • Action
    Customers are advised to check their inventory and quarantine any unused affected lots. Contact Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. This action has been closed-out on 17/08/2016.

Device

Edwards Pressure Monitoring Kit & Set
  • Model / Serial
    Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)Lot numbers: 59994210, 60001412, 60020166 & 60030868ARTG Number: 142521
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd