Type of Product |
Medical Device |
TGA Recall Reference |
RC-2017-RN-00636-1 |
Product Name/Description |
Kii abdominal trocars
5x55mm Kii Shielded Bladed Z-Thread Dual Pack Model Number: CTB14 Lot Numbers: 1288910, 1275207, 1279542 and 1283892
5x55mm Kii Low Profile Bladed Z-Thread Dual Pack Model Number: CTB23 Lot Numbers: 1281263, 1269692, 1288759 and 1271037
ARTG Number: 224148 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
19/05/2017 |
Responsible Entity |
|
Reason/Issue |
Applied Medical has identified the possibility that specific models and lots of Kii abdominal trocars have insufficient sterilisation |
Recall Action |
Recall |
Recall Action Instructions |
Users are requested to return any affected product with a copy of the Recall Notification Confirmation Form to Applied Medical as per the instructions in the Customer Letter.
This action has been closed out on the 14/09/2018. |
Contact Information |
07 3853 2100 - Applied Medical Australia |