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Recall Observatory FDA recall evidence

Device 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.

Z-2507-2015

July 29, 2015

Class II

Product summary

Firm
Halyard Health, Inc
Event
Event 71966
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2507-2015

Official wording

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.

Code information: Product Code 8224 - AB5161U07; Product Code 22106 - AB5117U03, AB5124U08, AB5124U20, AB5131U03; Product Code 221036 - AB5138U15, AB5161U05

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.