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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00539-1
Product Name/Description	Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot Pusher Pereyra-Raz Ligature Carrier Catalogue Identifier: 090002 All Lots Stamey Needle Catalogue Identifier: 095030, 095015 and 095000 All Lots Clarke-Reich Laparoscopic Knot Pusher Catalogue Identifier: J-CRKP-042900 All Lots ARTG Numbers: 212233 and 166926
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/05/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. Preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
Recall Action	Recall
Recall Action Instructions	Users are requested to: 1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products. 2. Complete and return the Acknowledgement and Receipt form provided as soon as possible. Users are further advised that supply of these products will be discontinued in Australia. This action has been closed out on 02/10/2018
Contact Information	1800 777 222 - Cook Medical Customer Service