Events

Recall of NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Aero Healthcare.

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
    RC-2016-RN-01138-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01138-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously.As the device is intended to penetrate the bone into the marrow cavity, it is designed in such way that the needle is released intensely due to a compressed spring force. spontaneous release of the needle from the device may result in serious injury of the patient, caregiver or any of the surrounding people.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Aero healthcare is advising users to return the affected units. This action has been closed-out on 26/05/2017.

Device

NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravasc...
  • Model / Serial
    NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)Lot Number: 160024ARTG Number: 145376
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare