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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00694-1
Product Name/Description	OptiLite Multi-Use Holmium Laser Fibers Catalogue Identifiers: HLF-M365-SMA, HLF-M365-SMA, HLF-M550-SMA, HLF-M940-SMA, HLF-M273-SMA, HLF-M273-CNV, HLF-M365-CNV & HLF-M550-CNV All Lots ARTG Number: 209642
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/06/2017
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook has identified that the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of the OptiLite Multi-Use Holmium Laser Fiber products. Preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. To date the manufacturer has received no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices. Potential adverse events that may occur if the products are not adequately reprocessed include localised surgical site infection, to deeper organ space infection, as well as chemical residual exposure.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising users to examine their inventory immediately to identify and quarantine any affected products. Products are to be discarded or returned to Cook Medical. This action has been closed out on 3/09/2018.
Contact Information	1800 777 222 - Cook Medical Customer Service