The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2495-2015·Announced 2015-09-09

Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

Halyard Health is recalling specific KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the device's intended function.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 safety of the airway circuit, representing a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Halyard Health, Inc. is recalling specific lots of KimVent Wet Pak Closed Suction Systems for adults. The affected products include 14 F and 16 F T-Piece configurations with specific product codes and lot numbers listed in the official recall notice. 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 on some of these systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This defect could prevent the system from maintaining the closed state required for safe use.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Users of these devices should stop using the affected units and contact Halyard Health for instructions on replacement or return.

The recalled product

Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A…
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 (8)

  • Product Code 22056 - AB5124U18
  • AB5138U01
  • AB5145U02
  • AB5145U05
  • AB5153U03
  • Product Code 22556 - AB5124U07
  • AB5131U04
  • Product Code 22012356 - AB5145U09

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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