| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00500-1 |
| Product Name/Description |
Cook LapSac Surgical Tissue Pouch
ARTG Number 212552 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Updates to the IFU are being made to discourage use of laparoscopic power morcellation in cases where the presence of cancerous tissue cannot be ruled out. The intended use for the device is being modified from "Used to isolate tissue during, or prior to, surgical removal and or morcellation" to "Used to isolate tissue during, or prior to surgical removal". A contraindication i.e., 'not for use with power morcellators' is also being added to the IFU. Additionally, warnings and instructions in the IFU is being updated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to pass the customer letter on to appropriate personnel within their organisation or to any organisation where the potentially affected devices have been transferred. This action has been closed-out on 26/08/2016. |
| Contact Information |
(07) 3434 6451
Cook Australia Pty Ltd |