| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00951-1 |
| Product Name/Description |
Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm
Product Code: ENG-17/1847/6
Batch/Lot Number: 117696
ARTG Number: 175488 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that there is a possible fault in the affected batches due to inadequate bonding between the coating and substrate in manufacturing, which may cause insulation to crack and lift away from the metal body. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers to identify and segregate any units from affected batch number and contact the sponsor to arrange return of recalled stock and order replacement stock. |
| Contact Information |
0431 963 777 - Sharon Heley |