Agency classClass IIOur severity:High FDA (Devices)·Z-2521-2015·Announced 2015-09-09

Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning, despite appearing closed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that poses a risk of harm to patients, but the source text does not report specific injuries or illnesses.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Neonates/Pediatrics, 5 F, Manifold (Product Code 201). The recall involves a tracheobronchial suction catheter device used to aspirate liquids or semisolids from a patient's upper airway. The affected units were distributed worldwide, including nationwide in the United States, Puerto Rico, and Canada.

The recall was initiated because the thumb valve of some units remained partially open after suctioning was completed. This occurred even though the valve appeared to be closed or in the "LOCKED" position. The agency has classified this recall as Class II.

Healthcare providers and consumers should stop using the affected KimVent Closed Suction Systems immediately. Users should contact Halyard Health, Inc. for instructions on how to return or replace the devices.

The recalled product

Product: KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) 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.
Manufacturer: Halyard Health, Inc
Category: Medical Device — Respiratory / Suction
Hazard: device-malfunction
airway-compromise

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Product Code 201 - M5076T405

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 32 recalled by Halyard Health, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · Halyard Health, Inc

See all →

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Halyard Closed Suction System Flex Connectors May Disconnect During Use
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High
Halyard Closed Suction System Flex Connectors May Disconnect During Use
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Moderate
Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes
FDA (Devices) · 2018-04-11
High
Halyard Closed Suction System Saline Vials Recalled for Potential Leaking
FDA (Devices) · 2017-11-29

Same hazard · device malfunction