Class I Recall of Vyaire Medical, Inc. Tri-Flo Subglottic Suction System

PUBLISHED: Sep 5, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

Vyaire Medical, Inc is recalling the Tri-Flo Subglottic Suction System because there is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs.

This may result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient's lungs, irritation and reddening of the skin (erythema) of the airways, infections or death.

Recalled Product:

  • Name: Tri-Flo Subglottic Suction System
  • Lot numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256
  • Model Number: CM28010
  • Manufacturing Dates: Unknown
  • Distribution Dates: January 23, 2018 to May 23, 2018
  • Devices Recalled in the U.S.: 2,150 units nationwide

On June 20, 2018, Vyaire Medical, Inc sent an Urgent Tri-Flo Subglottic Suction System Recall Notification letter to affected customers. The letter asked customers to:

  • Inspect current inventory and remove all affected Tri-Flo Subglottic Suction Systems.
  • Return all in-stock inventory affected by this recall by calling Vyaire Medical, Inc's Customer Service Support Team at 833-3BREATH (833-327-3284) (Option #1) Monday-Friday 7:00 am Central Standard Time - 5:30 pm Central Standard Time to obtain a pre-paid shipping Return. Goods Authorization (RGA). Requests for credit can be made by providing the original P.O. number for in-stock inventory.
  • Complete the Customer Response Form (Appendix 1) and return to GMB-GLB VSFieldActions@Vyaire.com. The letter also included instructions for customers that did not purchase the product directly through Vyaire Medical to work with the distributor to return or receive credit for in-stock inventory affected by this recall.
  • Notify customers of this recall if you are a facility that has further distributed affected product.

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