Agency classClass IIOur severity:Severe FDA (Devices)·Z-2517-2015·Announced 2015-09-09

Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters

Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving medical devices where the defect could compromise patient safety or device function.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Multi-Access Port Replacement Catheters for Adults, Tracheostomy, 14 F (Product Code 2401453-5). The recall involves a defect where 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.

This issue affects the KimVent Multi-Access Port Replacement Catheters distributed worldwide, including the United States (nationwide and Puerto Rico) and Canada. The product is a tracheobronchial suction catheter attached to a port of the airway circuit for aspirating liquids or semisolids from a patient's upper airway.

The FDA has classified this as a Class II recall. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions, but the defect involves the integrity of the closed suction system.

The recalled product

Product: KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) 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…
Manufacturer: Halyard Health, Inc
Category: Medical Device — Respiratory / Suction Catheter
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 (2)

Product Code 2401453-5 - M5105T801
M5105T802

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 Saline Vials Recalled for Potential Leaking
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Same hazard · device malfunction