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Recall Observatory FDA recall evidence

Device product

KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction System for Neonates/Pediatrics, 10 F, Elbow (Product Code 2103); KimVent* Closed Suction Systems for Neonates/Pediatrics, 8 F, Elbow (Product Code 8313); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 20083) 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-2522-2015

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-2522-2015

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 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 210 - M5091T509; Product Code 2103 - M5082T401, M5089T401, M5138T402; Product Code 8313 - M5089T508; Product Code 20083 - M5082T403, M5082T404, M5089T402, M5103T401, M5166T402

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.