The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2520-2015·Announced 2015-09-09

Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction

Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning.

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 is classified as FDA Class II, and the defect involves a medical device used on vulnerable neonates and pediatrics where a failure to seal the airway could lead to harm, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Halyard Health, Inc. is recalling KimVent Closed Suction Systems for Neonates/Pediatrics in various sizes (5 F, 6 F, 7 F, 8 F, 10 F, and 12 F) with Y-Adapters. The recall affects specific product codes and lot numbers distributed nationwide in the US, Puerto Rico, and internationally to Canada.

The recall is due to a defect where the thumb valve of some systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. This device is used to aspirate liquids or semisolids from a patient's upper airway.

Healthcare facilities and consumers should stop using the affected KimVent Closed Suction Systems immediately. Halyard Health is the recalling firm responsible for managing the recall.

The recalled product

Product
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197)…
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 (12)

  • Product Code 195 -M5061T407
  • Product Code 196 - M5076T506
  • M5096T503
  • M5110T505
  • Product Code 197- M5082T507
  • Product Code 198 - M5082T510
  • M5089T507
  • M5103T508
  • M5117T510
  • Product Code 1910 - M5082T513
  • Product Code 1912 - M5082T514
  • M5145T503

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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