| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00370-1 |
| Product Name/Description |
Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm
Batch number 15051
Expiry Date: 31 June 2020
ARTG number: 201258 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The device is typically used to protect wounds and arrest bleeding in an emergency situation. It consists of a pad attached to a roll bandage. The pad is applied directly to the wound and the bandage is subsequently wrapped around the pad. A pressure bar mechanism provides pressure to the wound site. It has been reported that the pressure bar material from a specific batch has inadequate strength and may break during use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Aero Healthcare is advising customers to inspect stocks and quarantine the affected units prior to their return. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 628 881 - Aero Healthcare |