Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics 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 and involves a medical device defect that 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 KimVent Closed Suction Systems for Neonates/Pediatrics, 5 F, Manifold (Product Code 201). The recall involves a tracheobronchial suction catheter device used to aspirate liquids or semisolids from a patient's upper airway. The affected units were distributed worldwide, including nationwide in the United States, Puerto Rico, and Canada.
The recall was initiated because the thumb valve of some units remained partially open after suctioning was completed. This occurred even though the valve appeared to be closed or in the "LOCKED" position. The agency has classified this recall as Class II.
Healthcare providers and consumers should stop using the affected KimVent Closed Suction Systems immediately. Users should contact Halyard Health, Inc. for instructions on how to return or replace the devices.
The recalled product
- Product
- KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) 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 201 - M5076T405
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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