Agency classClass IIOur severity:High FDA (Devices)·Z-2492-2015·Announced 2015-09-09

Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, 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 Adults (12 F and 14 F T-Piece configurations). The recall involves 19,250 cases distributed nationwide in the United States, Puerto Rico, Canada, and internationally.

The recall was initiated because the thumb valve on some of these devices remained partially open after suctioning was completed, even when the valve appeared to be in the closed or "LOCKED" position. This defect could affect the integrity of the closed suction system used to aspirate liquids or semisolids from a patient's upper airway.

Healthcare providers and facilities should stop using the affected product codes and contact Halyard Health for instructions on return or replacement. The affected product codes include 2155, 2205, 8169, 8248, 22015, 22025, 220125, and 220135.

The recalled product

Product: KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of…
Manufacturer: Halyard Health, Inc
Category: Medical Device — Respiratory / Suction
Hazard: device-malfunction
airway-compromise
Affected units: 19,250

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 (20)

Product Code 2155 - M5166T402
M5166T622
M5166T631
Product Code 2205 - M5079T606
M5086T603
M5089T612
M5089T632
M5110T611
M5110T626
M5166T642
Product Code 8169 - M5103T608
Product Code 8248 - M5082T632
Product Code 22015 - M5082T603
M5089T609
M5096T607
Product Code 22025 - M5082T627
M5096T603
Product Code 220125 M5082T617
M5096T608
Product Code 220135 - M5054T619

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
FDA (Devices) · 2018-04-25
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