Events

Recall of Edwards Lifesciences Pressure Monitoring Kit and Set

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Edwards Lifesciences LLC.

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
    19026
  • Event Initiated Date
    2015-08-28
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Edwards Lifesciences (New Zealand) Limited, 171 Morrin Road, St John, Auckland 1072
  • Reason
    Edwards lifesciences is recalling specfic lots of product due to a flow restriction issue 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.
  • Action
    Product to be returned to supplier

Device

Edwards Lifesciences Pressure Monitoring Kit and Set
  • Model / Serial
    Model: PXMK2043 & PXMK2217, Affected: PXMK2043, Lot numbers 59994210, 60001412, 60020166 & 60030868 and PXMK2217 Lot numbers 59994267, 60020235 & 60030969
  • Manufacturer
    Edwards Lifesciences LLC

Manufacturer

Edwards Lifesciences LLC