Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent 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 involves a medical device with a functional defect that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Halyard Health, Inc. is recalling the KimVent Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308). 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 units remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This malfunction 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. Healthcare providers and facilities should stop using the affected units and contact Halyard Health for instructions on replacement or return.
The recalled product
- Product
- KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) 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 airway.
- 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 8308 - M5082T305
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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