The Recall Desk
HighFDA (Devices)·Z-2497-2015·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, potentially 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 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 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 KimVent Closed Suction Systems for Adults, 12 F, T-Piece, 12 in Tracheostomy (Product Codes 215135 and 21513511). 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.

This device is a tracheobronchial suction catheter attached to an 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.

Healthcare facilities and users should stop using the affected KimVent Closed Suction Systems and contact Halyard Health for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tracheobronchial suction catheter is a device that is attached to a port of the 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 (2)

  • Product Code 215135 - M5096T618
  • Product Code 21513511 M5096T617

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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