The Recall Desk
HighFDA (Devices)·Z-2519-2015·Announced 2015-09-09

Halyard KimVent Suction Catheter Thumb Valve Recall

Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction 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 involves a medical device defect that compromises the integrity of a closed suction system, posing a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Multi-Access Port Replacement Catheters for Adults, Endotracheal, 16 F (Product Code 240165-5). The recall is due to a defect where the thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

This product is a tracheobronchial suction catheter attached to a port of the airway circuit to aspirate liquids or semisolids from a patient's upper airway. The affected units were distributed worldwide, including the United States (nationwide and Puerto Rico) and Canada.

Healthcare facilities and users should stop using the affected KimVent Multi-Access Port Replacement Catheters and contact Halyard Health for further instructions on the recall.

The recalled product

Product
KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper air
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Suction
Hazard

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 (1)

  • Product Code 240165-5 - M5089T807

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 →

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