The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2501-2015·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 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 risk-of-harm product where the failure of a critical safety mechanism (the thumb valve) could lead to patient injury, although specific injury reports are not detailed in the source text.

Plain-English summary

Halyard Health, Inc. is recalling the NovaPlus Trach Care Closed Suction System for Adults, Clear T-Piece with MDI Adapter, 14F (Product Code 2V220158). This medical device is a tracheobronchial suction catheter attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.

The recall was initiated because 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 defect could compromise the closed system's ability to maintain airway protection.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Users of these devices should contact Halyard Health for further instructions on how to proceed with the recall.

The recalled product

Product
NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Adapter, 14F (Product Code 2V220158) 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 (2)

  • Product Code 2V220158 - M5082T629
  • M5089T623

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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