| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00570-1 |
| Product Name/Description |
Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers
Multiple model numbers
ARTG Numbers: 145536 &169227 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
American Medical Systems (AMS) has determined that the validation data related to cleaning instructions and sterilisation methods and the methods defined in instructions for use (IFU) do not meet the new guidance on qualifying reusable products. |
| Recall Action |
Recall |
| Recall Action Instructions |
AMS is requesting the return of all unused inventory in the field. If the inventory has been used, and has not been discarded, AMS is requesting that the customers discard the devices or return the used device to AMS directly. AMS will be extending a credit to the customers for the purchase price.
This action has been closed out on 24/10/2018 |
| Contact Information |
1800 642 325 Customer Service |