The Recall Desk
HighFDA (Devices)·Z-2496-2015·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, compromising the closed 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 is classified as FDA Class II. The hazard involves a mechanical failure in a medical device used for airway management, which poses a risk of harm if the closed system is compromised, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, specifically the 14 F, D-Tip, T-Piece (Product Code 22059) and 14 F, T-Piece, Directional Tip (Product Code 8155) models. The recall is due to a defect where the thumb valve may remain partially open after suctioning is completed, even when the valve appears to be closed or in the "LOCKED" position.

A tracheobronchial suction catheter is a device attached to the airway circuit to aspirate liquids or semisolids from a patient's upper airway. The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Specific lot codes affected include M5076T619, M5082T608, M5085T603 for Product Code 22059, and M5082T606 for Product Code 8155.

Healthcare facilities and users should stop using the affected KimVent Closed Suction Systems and contact Halyard Health for instructions on return or replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit fo
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Airway Management
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 (4)

  • Product Code 22059 - M5076T619
  • M5082T608
  • M5085T603
  • Product Code 8155 - M5082T606

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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