France

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.

All users of the affected analyzers are required to reply to the notification letter within 10 days and implement increased monitoring of device performance to prevent liquid leaks.

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.