Events

Recall of Medcom Hemo-Cath ST Hemodialysis Catheters

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

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
    18735
  • Event Initiated Date
    2015-06-30
  • 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: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has updated the instructions for use (ifu) to include an instruction for the catheter not to be clamped. clamping the catheter can cause holes in the catheter causing leaks potentially leading to blood loss, air emboli, infection, delays in treatment, and a surgical procedure to remove and replace the device prior to continuing the dialysis treatment.
  • Action
    Instructions for use to be updated

Device

Medcom Hemo-Cath ST Hemodialysis Catheters
  • Model / Serial
    Model: All models, Affected: All lot numbers
  • Manufacturer
    Medcomp Inc

Manufacturer

Medcomp Inc