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.
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 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…
- Manufacturer
- Halyard Health, Inc
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
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.
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