Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect
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.
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 hazard involves a medical device defect that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Halyard Health, Inc. is recalling specific lots of the NovaPlus Trach Care Closed Suction System for Adults. The affected products include the T-Piece, 14F (Product Code 2V220135) and the Clear T-Piece, 14F (Product Code 2V2205). These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.
The recall was initiated because the thumb valve on some of these systems remained partially open after suctioning was completed, even when the valve appeared to be closed or in the "LOCKED" position. This defect could compromise the closed nature of the suction system.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Specific lot numbers are listed in the structured product information. Healthcare providers and patients should stop using these devices and contact Halyard Health for instructions on replacement or return.
The recalled product
- Product
- NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway c
- 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 (6)
- Product Code 2V220135 - M5081T602
- M5089T607
- M5089T628
- M5106T601
- Product Code 2V2205 - M5079T605
- M5089T608
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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