Agency classClass IIOur severity:High FDA (Devices)·Z-2507-2015·Announced 2015-09-09

Halyard Recalls KimVent Closed Suction Systems 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 involves a medical device defect that compromises the closed system, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Halyard Health, Inc. is recalling specific lots of KimVent Wet Pak Closed Suction Systems for adults. The affected products are 14 French, DSE, and include product codes 8224, 22106, and 221036. 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 of some units 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 units and contact Halyard Health for instructions on return or replacement.

The recalled product

Product: KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction…
Manufacturer: Halyard Health, Inc
Category: Medical Device — Respiratory / Suction
Hazard: device-malfunction
valve-failure

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 (7)

Product Code 8224 - AB5161U07
Product Code 22106 - AB5117U03
AB5124U08
AB5124U20
AB5131U03
Product Code 221036 - AB5138U15
AB5161U05

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 →

High
Halyard Closed Suction System Recall Due to Loose Flex Connectors
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