The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2512-2015·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, even when it appears 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 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 poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Turbo-Cleaning Closed Suction Systems for Adults (14 F and 12 F, DSE). The affected products are tracheobronchial suction catheters used to aspirate liquids or semisolids from a patient's upper airway.

The recall is due to a defect where the thumb valve may remain partially open after suctioning is completed, even though the valve appears to be closed or in the "LOCKED" position. This issue could compromise the closed suction system's function.

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

The recalled product

Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 22703); KimVent* Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 22716) A…
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 (6)

  • Product Code 227 - M5082T308
  • M5166T305
  • Product Code 22703 - M5082T309
  • M5103T315
  • Product Code 22716 - M5091T312
  • M5145T304

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 →

Related recalls

Same manufacturer · Halyard Health, Inc

See all →

Same hazard · device malfunction

See all →

Similar recalls