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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 American Medical Systems Australia Pty Ltd
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