The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2502-2015·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 use, potentially compromising airway protection.

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 involves a medical device used for airway management where failure could lead to harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling the NovaPlus Trach Care Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059). The recall involves units where the thumb valve may remain partially open after suctioning is completed, even if the valve appears to be in the closed or "LOCKED" position.

This defect poses a risk to patients because the closed suction system is designed to maintain a sterile, closed airway circuit. If the valve does not seal properly, the system may fail to protect the patient's airway from contamination or loss of pressure. The affected product is a tracheobronchial suction catheter attached to the airway circuit for aspirating liquids or semisolids from the upper airway.

The affected units were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Healthcare providers and facilities should check their inventory for Product Code 2V22059 and stop using any units that exhibit this valve malfunction. Patients and caregivers should contact their healthcare provider for guidance on safe alternatives or replacement devices.

The recalled product

Product
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) 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 2V22059 - M5082T611

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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