The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2516-2015·Announced 2015-09-09

Halyard KimVent Closed Suction System Thumb Valve Recall

Halyard Health is recalling KimVent Multi-Access Port Closed Suction Systems 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. The hazard involves a medical device failure that could compromise airway management, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Multi-Access Port Closed Suction Systems for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5). The recall involves a defect where 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.

The affected devices are tracheobronchial suction catheters attached to an airway circuit port to aspirate liquids or semisolids from a patient's upper airway. The recall covers units distributed worldwide, including the United States (nationwide and Puerto Rico) and Canada.

Healthcare facilities and users should stop using the affected KimVent systems and contact Halyard Health for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) 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…
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Suction
Hazard

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 24-14-5 - M5138T802

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 →

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