Cook Multi-Use Holmium Laser Fibers 의 리콜

Recall

RC-2017-RN-00696-1

Class II

2017-05-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00696-1

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.

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.