The Recall Desk
HighFDA (Devices)·Z-2523-2015·Announced 2015-09-09

Halyard KimVent Pediatric Closed Suction System Thumb Valve Defect Recall

Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.

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 defect involves a critical airway management component where a failure to seal could pose a risk of harm to patients, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Halyard Health, Inc. is recalling the KimVent Wet Pak Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281). This medical device is a tracheobronchial suction catheter attached to an airway circuit port to aspirate liquids or semisolids from a patient's upper airway.

The recall was initiated because the thumb valve of some affected units remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This defect 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 facilities and users should stop using the affected devices and contact Halyard Health for instructions on return or replacement.

The recalled product

Product
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) 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 / 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 (2)

  • Product Code 8281  AB5138U08
  • AB5145U16

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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