The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2494-2015·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, despite appearing locked.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are classified as Severe (Score 4).

Plain-English summary

Halyard Health, Inc. is recalling KimVent Wet Pak Closed Suction Systems for Adults, 14 F, DT, T-Piece (Product Code 220569). The recall involves specific lot codes: AB5145U14, AB5166U09, and AB5180U11. These devices are tracheobronchial suction catheters used 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. This occurred even though the valve appeared to be closed or in the "LOCKED" position. The agency has classified this as a Class II recall.

The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on replacement or return.

The recalled product

Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) 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 220569 - AB5145U14
  • AB5166U09
  • AB5180U11

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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