| TGA Action ID |
RC-2025-RN-00151-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Custom Made PSI Bone Model
Item code: SA24063903
Lot number: 25060FN001
ARTG exempt
|
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A minor labelling error on a custom-made Class IIa medical device (bone model) has been identified.
The device is Gamma sterilised. However, the label on the internal plastic bag is incorrectly marked as EO (ETO sterilisation) instead of R (Gamma Sterilization). The external label has been rightly marked as Gamma sterilised.
This neither impacts the sterility nor safety of the packed device. The correct sterilisation method is gamma irradiation which has been performed on this instrument. The mislabelling does not lead to a hazardous situation or pose a hazard for the patient or for the surgeon. |
| Instructions for Customers/Users |
The surgeon is to be aware of the labelling discrepancy and that the device has been sterilised correctly and can be used as intended.
This action has been finalised on 24/10/2025. |
| Action Commencement Date |
6/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 168 - Life Healthcare |