Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Turbo-Cleaning Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
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. The hazard involves a mechanical failure in a medical device used for airway management, which poses a risk of harm to patients, but the source text does not report specific injuries or illnesses.
Plain-English summary
Halyard Health, Inc. is recalling the KimVent Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Codes 22705 and 2270135). The recall involves specific lot numbers M5082T301, M5096T315, M5076T321, and M5082T306. These devices are tracheobronchial suction catheters attached to an airway circuit port to aspirate liquids or semisolids from a patient's upper airway.
The recall was initiated because the thumb valve of some units 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 integrity of the closed suction system.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Healthcare providers and facilities should stop using the affected units and contact Halyard Health for instructions on return or replacement.
The recalled product
- Product
- KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the…
- 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 (4)
- Product Code 22705 - M5082T301
- M5096T315
- Product Code 2270135 - M5076T321
- M5082T306
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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