Halyard Health, Inc: Medical Device Recall in 2015 - (Recall #: Z-2520-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
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.
Class II
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.
Product Code 195 -M5061T407; Product Code 196 - M5076T506, M5096T503, M5110T505; Product Code 197- M5082T507; Product Code 198 - M5082T510, M5089T507, M5103T508, M5117T510; Product Code 1910 - M5082T513; Product Code 1912 - M5082T514, M5145T503
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Voluntary: Firm initiated