| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01138-1 |
| Product Name/Description |
NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)
Lot Number: 160024
ARTG Number: 145376 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
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) |
| Recall Action |
Recall |
| Recall Action Instructions |
Aero healthcare is advising users to return the affected units. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 6776 7200 - Aero Healthcare |