The Recall Desk
HighFDA (Devices)·Z-2492-2015·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, and the defect presents a risk of harm to patients by compromising the closed suction system, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling specific lots of KimVent Closed Suction Systems for Adults (12 F and 14 F T-Piece configurations). The recall involves 19,250 cases distributed nationwide in the United States, Puerto Rico, Canada, and internationally.

The recall was initiated because the thumb valve on some of these devices remained partially open after suctioning was completed, even when the valve appeared to be in the closed or "LOCKED" position. This defect could affect the integrity of the closed suction system used to aspirate liquids or semisolids from a patient's upper airway.

Healthcare providers and facilities should stop using the affected product codes and contact Halyard Health for instructions on return or replacement. The affected product codes include 2155, 2205, 8169, 8248, 22015, 22025, 220125, and 220135.

The recalled product

Product
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of t
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Suction
Hazard
Affected units
19,250

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 (20)

  • Product Code 2155 - M5166T402
  • M5166T622
  • M5166T631
  • Product Code 2205 - M5079T606
  • M5086T603
  • M5089T612
  • M5089T632
  • M5110T611
  • M5110T626
  • M5166T642
  • Product Code 8169 - M5103T608
  • Product Code 8248 - M5082T632
  • Product Code 22015 - M5082T603
  • M5089T609
  • M5096T607
  • Product Code 22025 - M5082T627
  • M5096T603
  • Product Code 220125 M5082T617
  • M5096T608
  • Product Code 220135 - M5054T619

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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