The Recall Desk
HighFDA (Devices)·Z-2505-2015·Announced 2015-09-09

Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, 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 is classified as FDA Class II. The hazard involves a mechanical failure that compromises the closed nature of the suction system, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Wet Pak Closed Suction Systems for Adults, 14 F, Elbow (Product Codes 2276 and 22169). The recall involves specific lot numbers: AB5131U06, AB5138U04, AB5161U12 for Product Code 2276, and AB5131U09, AB5145U03 for Product Code 22169. These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.

The recall was initiated because the thumb valve of some affected systems 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 lots and contact Halyard Health for instructions on return or replacement.

The recalled product

Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as n
Manufacturer
Halyard Health, Inc
Category
Medical Device — Suction Catheter
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 (5)

  • Product Code 2276 -AB5131U06
  • AB5138U04
  • AB5161U12
  • Product Code 22169 - AB5131U09
  • AB5145U03

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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