The Recall Desk
HighFDA (Devices)·Z-2513-2015·Announced 2015-09-09

Halyard KimVent Closed Suction Systems Recalled Due to Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

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: This is a Class II recall for a medical device with a functional defect that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273). These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.

The recall is due to a defect where the thumb valve of some systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This issue could compromise the closed nature of the suction system.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Specific lot codes identified in the recall are M5076T311, M5082T316, and M5103T320. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) 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 airway.
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 (3)

  • Product Code 2273 - M5076T311
  • M5082T316
  • M5103T320

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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