FDA-Device2015-09-09Class II

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Product Code 198); KimVent* Closed Suction System for Neonates/Pediatrics 10 F, Y-Adapter (Product Code 1910); KimVent* Closed Suction System for Neonates/

Halyard Health, Inc

Hazard

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.

Sold states

Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

Affected count

N/A

Manufactured in

5405 Windward Pkwy, N/A, Alpharetta, GA, United States

Products

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Product Code 198); KimVent* Closed Suction System for Neonates/Pediatrics 10 F, Y-Adapter (Product Code 1910); KimVent* Closed Suction System for Neonates/.Pediatrics, 12 F, Y-Adapter (Product Code 1912) 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2015

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