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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00696-1
Product Name/Description	Cook Multi-Use Holmium Laser Fibers Catalogue Identifiers: HLF-M273-H30, HLF-M365-H30, HLF-M550-H30, HLF-M940-H30, HLF-M273-HSMA, HLF-M365-HSMA, HLF-M550-HSMA & HLF-M940-HSMA Part Numbers: G23668, G23667, G23666, G23665, G25298, G25299, G25300 & G25301 (respectively) All Lots ARTG Number: 209642
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/05/2017
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. In addition, the monitoring of chemical residues was not considered in the reprocessing validation. Preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidelines. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. To date, there have been no reports of adverse reactions related to inadequate cleaning, disinfection, sterilisation or chemical residual exposure associated with these devices.
Recall Action	Recall for Product Correction
Recall Action Instructions	Cook Medical will be updating the reprocessing instructions in the Instructions For Use (IFU). In the interim, users are advised to quarantine any affected products. Use of the affected products can be continued if the updated "Suggested Fiber Reprocessing Instructions" provided is adhered to. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 777 222 - Cook Medical Customer Service