Events

Recall of Apatech Actifuse MIS System & refill

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

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
    19027
  • Event Initiated Date
    2015-08-26
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    The manufacturer is recalling all lots of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
  • Action
    Product to be returned to supplier

Device

Apatech Actifuse MIS System & refill
  • Model / Serial
    Model: 506005078069, 506005078071, Affected: All lots with expiry date before 29-Jul-2017
  • Manufacturer
    Apatech Limited

Manufacturer

Apatech Limited