Events

Recall of Atrium Thoracic Catheters

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

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
    21131
  • Event Initiated Date
    2017-02-22
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    The manufacturer is providing clarification about the current labelling on two models of atrium thoracic catheters. the atrium thoracic catheters are packaged with a label containing an icon that depicts the product as having multiple eyelets. the graphical icon is designed to represent a generic thoracic catheter, and does not accurately reflect the actual eyelet configuration of the product contained in the package. the packaging is transparent allowing visualization of the actual number of eyelets on the thoracic catheter.
  • Action
    Manufacturer to issue advice regarding use

Device

Atrium Thoracic Catheters
  • Model / Serial
    Model: , Affected: 8 Fr Thoracic Catheter code number 8008 All lot numbers, 10 Fr Thoracic Catheter code number 8010 All lot numbers
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA