RecallRadar

FDA Device recall Z-2520-2015

KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195)

On 2015-09-09 the FDA classified a Class II recall of KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195) by Halyard Health, citing 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" posit….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2520-2015
ClassificationClass II
Statusterminated
Initiated2015-07-29
Published2015-09-09
Last updated2026-09-13 11:53 UTC
CompanyHalyard Health
DistributionUS

Product

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.

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.

Identifiers

code_info
Product Code 195 -M5061T407; Product Code 196 - M5076T506, M5096T503, M5110T505; Product Code 197- M5082T507; Product C…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2015%22

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