Events

Recall of Medcomp Hemo-cath®LT and 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
    18956
  • Event Initiated Date
    2015-08-04
  • 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: AA-Med NZ Ltd, 6 Church Lane, Point Howard, Lower Hutt, Wellington 5013
  • Reason
    Manufacturer notification of potential safety issue affecting medcomp hemo-cath lt and hemo-cath st hemodialysis catheters which may develop holes during use. investiagtion determined that during the insertion procedure engaging the extension line clamp over the guidewire may damage the inside of the tubing. a crack in the tubing on the inside can propagate over time and eventually travel through thickness of the tubing developong into a hole that leaks.
  • Action
    Manufacturer to issue advice regarding use

Device

Medcomp Hemo-cath®LT and Hemo-cath®ST Hemodialysis Catheters
  • Model / Serial
    Model: LT and ST, Affected: ECS1316 ECS1320 and ECS1324
  • Manufacturer
    Medcomp Inc

Manufacturer

Medcomp Inc