| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00854-3 |
| Product Name/Description |
Intuitive Surgical Version 12 Tip Cover for 8mm Monopolar Curved Scissors (endotherapy scissors)
Part Number: INS-400180 version 12
Multiple lots affected
ARTG Number: 97369 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
During the manufacturing process, the sealed edge may not have been uniformly formed and pleats or creases may have been formed which could
have the potential to compromise the barrier integrity of the pouch. |
| Recall Action |
Recall |
| Recall Action Instructions |
Identify and quarantine affected products. Return the quarantined stock to Device Technologies for replacement stock or credit. |
| Contact Information |
1800 429 551 - Device Technologies Regulatory Affairs |