Agency classClass IIOur severity:High FDA (Devices)·Z-2499-2015·Announced 2015-09-09

Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.

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 involves a medical device with a functional defect that compromises its intended safety mechanism (closed suction), representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358) and KimVent Closed Suction Systems for Adults, 14 F, MDI, T-Piece (Product Code 2201258). These devices are tracheobronchial suction catheters attached to an airway circuit port to aspirate liquids or semisolids from a patient's upper airway.

The recall was initiated because the thumb valve of some units remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This malfunction could compromise the closed nature of the suction system.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Users should stop using the affected devices and contact Halyard Health for instructions on replacement or return.

The recalled product

Product: KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358); KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece (Produce Code 2201258) A tracheobronchial suction catheter is a device that is attached to a port of the…
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 (3)

Product Code 2201358 - M5089T629
Product Code 2201258 - M5082T619
M5089T622

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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Halyard Closed Suction System Saline Vials Recalled for Potential Leaking
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Same hazard · device malfunction