Halyard NovaPlus Trach Care Closed Suction System Thumb Valve Recall
Halyard Health is recalling NovaPlus Trach Care 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 to patients by compromising the closed suction system, although 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, Double Swivel Elbow, 14F (Product Code 2V2210). The recall involves specific lot codes M5082T630 and M5096T641. The product was distributed nationwide in the United States, including Puerto Rico, as well as internationally to Canada.
The recall was initiated because the thumb valve of some affected units remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This defect may compromise the integrity of the closed suction system.
Healthcare providers and facilities should stop using the affected devices and contact Halyard Health for instructions on return or replacement. Consumers should not use the recalled product and should contact the manufacturer for further guidance.
The recalled product
- Product
- NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) 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 upper airwa
- 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 (2)
- Product Code 2V2210 - M5082T630
- M5096T641
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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