Device product
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Z-2517-2015
Product summary
- Event
- Event 71966
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2517-2015
Official wording
Reason: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
Code information: Product Code 2401453-5 - M5105T801, M5105T802
Distribution pattern: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Derived failure modes
-
Unknown
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.