Halyard Health, Inc recalls KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction Syst…

Recall date

July 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2520-2015

FDA classification

Class II

Brand / firm

Halyard Health, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.