The Recall Desk
HighFDA (Devices)·Z-2518-2015·Announced 2015-09-09

Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.

What this means for you

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 poses a risk of harm by compromising the closed system, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Multi-Access Port Closed Suction Systems for Adults, Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5). The recall involves a defect where the thumb valve of the device may remain partially open after suctioning is completed, even if the valve appears to be closed or in the "LOCKED" position.

This defect could compromise the integrity of the closed suction system, which is designed to maintain a sterile environment during airway management. The affected devices are tracheobronchial suction catheters attached to the airway circuit 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 replacement or return.

The recalled product

Product
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) 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 / Airway Management
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 240438-5 - M5105T809

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 →

Related recalls

Same manufacturer · Halyard Health, Inc

See all →

Same hazard · device malfunction

See all →