The Recall Desk
HighFDA (Devices)·Z-2510-2015·Announced 2015-09-09

Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway safety.

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 involves a medical device with a functional defect that could compromise airway safety, but the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Halyard Health, Inc. is recalling the NovaPlus Trach Care Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109). The recall is due to a defect where the thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

This product is a tracheobronchial suction catheter attached to a port of the airway circuit to aspirate liquids or semisolids from a patient's upper airway. The affected units 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 how to proceed. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) 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 pat
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Airway
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 2V22109 - M5076T629

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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