The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2515-2015·Announced 2015-09-09

Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed 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 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 the defect presents a risk of harm to patients by compromising the closed suction system, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling the KimVent Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418). This medical device is a tracheobronchial suction catheter attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.

The recall is due to a defect where the thumb valve of some systems 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 integrity of the closed suction system.

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

The recalled product

Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) 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 — Suction Catheter
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 2271418 - M5076T322

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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