Agency classClass IIOur severity:High FDA (Devices)·Z-2522-2015·Announced 2015-09-09

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.

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, 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…
Manufacturer: Halyard Health, Inc
Category: Medical Device — Respiratory / Suction
Hazard: device-malfunction
airway-compromise

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 32 products in this recall →

Same manufacturer · Halyard Health, Inc

See all →

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FDA (Devices) · 2018-04-25
High
Halyard Closed Suction System Flex Connectors May Disconnect During Use
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High
Halyard Closed Suction System Flex Connectors May Disconnect During Use
FDA (Devices) · 2018-04-25
Moderate
Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes
FDA (Devices) · 2018-04-11
High
Halyard Closed Suction System Saline Vials Recalled for Potential Leaking
FDA (Devices) · 2017-11-29

Same hazard · device malfunction