Halyard KimVent Closed Suction Systems 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 the closed system.
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 defect presents a risk of harm to patients by compromising the closed suction system, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Halyard Health, Inc. is recalling specific lots of KimVent Closed Suction Systems for neonates and pediatrics. The affected products include 6 F, 8 F, and 10 F elbow configurations with various product codes and lot numbers. These devices are tracheobronchial suction catheters attached to airway circuits to aspirate liquids or semisolids from a patient's upper airway.
The recall is due to a defect where the thumb valve of some systems 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 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 devices and contact Halyard Health for further instructions on returns or replacements.
The recalled product
- Product
- KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction Sys
- 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 (16)
- Product Code 206 - M5076T503
- M5082T501
- M5091T504
- Product Code 208 - M5089T506
- M5096T507
- M5103T509
- Product Code 210 - M5091T509
- Product Code 2103 - M5082T401
- M5089T401
- M5138T402
- Product Code 8313 - M5089T508
- Product Code 20083 - M5082T403
- M5082T404
- M5089T402
- M5103T401
- M5166T402
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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