Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
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. Per the rubric, this falls under 'High' severity as it involves a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, 14 F, DSE, DT (Product Code 22109). These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.
The recall is due to a defect where the thumb valve may remain partially open after suctioning is completed, even when the valve appears to be closed or in the "LOCKED" position.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. The source text does not specify the number of units recalled or report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) 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
- Hazard
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 22109 - M5082T607
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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