| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01102-1 |
| Product Name/Description |
Kii Abdominal Troacar
5x55mm Kii Optical Z-Thread Dual Pack
Model Number: CTR14
Lot Numbers: 1269694, 1275188, 1279039, 1283226, and 1287785
ARTG Number: 224148 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Applied Medical has been advised that during shipment, the packaging of specific lots of Kii Abdominal Troacars have the potential to become punctured with small holes, which would compromise the sterile barrier. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Users are to complete the Customer Recall Notification Confirmation Form supplied with the customer letter to acknowledge the recall and indicate if they are returning or have already used the affected lots.
2. If no product is being returned, indicate this on the supplied Customer Recall Notification Confirmation Form
3. Return the supplied Recall Notification Confirmation Form to Applied Medical Australia
4. Return affected product and a copy of the supplied Recall Notification Confirmation Form to Applied Medical.
This action has been closed out on the 12/10/2018. |
| Contact Information |
07 3853 2100 - Applied Medical |