| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00313-1 |
| Product Name/Description |
Torix Disposable Toric IOL Marking and Alignment System
Product codes:
HYX-FG-02510 (10 sets sterilised)
HYX-M-02512 (single pack)
HYX-M-02530 (Intra-operative Axis Guide)
HYX-M-02515 (Pre-operative Marker & Handle)
Lot number: W06710
ARTG Number: 200725 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The outer carton of these products has a 12 month expiry date (2013-12), the inner product has a 6 month expiry date (2013-02). |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect their stock and quarantine all affected units so that Ingeneus can recover quarantined units. |
| Contact Information |
03 9558 6334 - Ingeneus Quality Assurance and Regulatory Affairs |