The Recall Desk
HighFDA (Devices)·Z-2508-2015·Announced 2015-09-09

Halyard KimVent Closed Suction System Recall for Valve Defect

Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

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 medical device used for airway management where a failure to maintain a closed system poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Adults, 14 F, DSE, MDI (Product Codes 22108 and 221038). The recall involves specific lot numbers: M5082T626, M5089T625, M5089T606, and M5089T631.

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 closed nature of the suction system during use.

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 units and contact Halyard Health for instructions on return or replacement.

The recalled product

Product
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to a
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 (4)

  • Product Code 22108 - M5082T626
  • M5089T625
  • Product Code 221038 - M5089T606
  • M5089T631

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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