Agency classClass IIOur severity:High FDA (Devices)·Z-2506-2015·Announced 2015-09-09

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, even when it appears locked.

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 using the medical device, 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 adults. The affected products include 12 F and 14 F sizes with DSE specifications, identified by product codes 2210, 21603, 22103, and 22714183. These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.

The recall was initiated because the thumb valve on some units remained partially open after suctioning was completed, despite the valve appearing to be closed or in the "LOCKED" position. This defect could compromise the closed system's integrity during use.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Specific lot numbers affected include M5054T630, M5082T625, M5089T611, M5117T627, M5089T618, M5103T610, M5089T617, and M5082T318. Healthcare facilities and users 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, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE…
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 (8)

Product Code 2210 - M5054T630
M5082T625
M5089T611
M5117T627
Product Code 21603 - M5089T618
M5103T610
Product Code 22103 - M5089T617
Product Code 22714183 M5082T318

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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Halyard Closed Suction System Flex Connectors May Disconnect During Use
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Halyard Closed Suction System Flex Connectors May Disconnect During Use
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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