The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2509-2015·Announced 2015-09-09

Halyard KimVent Closed Suction System Thumb Valve Recall

Halyard Health is recalling KimVent 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. Per the rubric, this falls under 'High' severity as it involves a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, 14 F, DSE, DT (Product Code 22109). These devices are tracheobronchial suction catheters 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 may remain partially open after suctioning is completed, even when the valve appears to be closed or in the "LOCKED" position.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. The source text does not specify the number of units recalled or report any specific injuries or illnesses associated with this defect.

The recalled product

Product
KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) 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 Care
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 22109 - M5082T607

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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