RecallRadar

FDA Device recall Z-2507-2015

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224)

On 2015-09-09 the FDA classified a Class II recall of KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224) 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-2507-2015
ClassificationClass II
Statusterminated
Initiated2015-07-29
Published2015-09-09
Last updated2026-09-13 11:53 UTC
CompanyHalyard Health
DistributionUS

Product

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) 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_infoProduct Code 8224 - AB5161U07; Product Code 22106 - AB5117U03, AB5124U08, AB5124U20, AB5131U03; Product Code 221036 - AB5138U15, AB5161U05

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-2507-2015%22

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