The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2498-2015·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, potentially 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 involves a medical device defect that compromises the integrity of a closed suction system, posing a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Turbo-Cleaning Closed Suction Systems for Adults, 10 F, T-Piece (Product Code 227105). 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.

This device is a tracheobronchial suction catheter attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway. The affected units were distributed nationwide in the United States, Puerto Rico, and internationally to Canada.

Healthcare providers and facilities should stop using the affected KimVent systems and contact Halyard Health for instructions on how to return or replace the devices.

The recalled product

Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) 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 / 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 227105 - M5098T319

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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