FDA Medical Device Recalls (openFDA)
Vyaire Medical: The Tri-Flo Subglottic Suction System
- Recall number
- Z-2826-2018
- Recalling firm
- Vyaire Medical
- Product
- The Tri-Flo Subglottic Suction System
- Status
- Terminated
- Initiated
- 2018-06-20
- Posted
- 2018-08-21
- Terminated
- 2020-07-28
- Reason
- Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
- Root cause
- Process control
- Action
- The firm notified its customers on/about 06/20/2018 via a letter entitled " URGENT: Tri-Flo" Subglottic Suction System RECALL NOTIFICATION". This letter described the affected part, and lot numbers as well as the distribution dates for affected part numbers. The letter described the following actions to be taken by the customer which include: 1) Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove the Tri-Flo TM Subglottic Suction Systems (CM28010) from distribution due to the identified potential patient safety risk. 2) If a facility has further distributed affected product, Vyaire states a entity must further notify customers of this URGENT RECALL NOTIFICATION . 3) Return all in-stock inventory affected by this recall by calling Vyaire's Customer Service Support team at 833-3BREATH (833-327-3284) (Option #1) Monday-Friday 7:00 am CST- 5:30 pm CST 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. 4) Complete the Customer Response Form (Appendix 1) and return to GMB-GLB VSFieldActions@Vyaire.com. The letter also included instructions if an end-user customer/ facility 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. Any additional questions concerning this voluntary Recall, the firm recommended contacting Lindy Schenning at 1.872.757.0109 or via e-mail at Lindy.Schenning@Vyaire .com.
- Quantity
- 2150 Units Total
- Distribution
- Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
- Lot, serial or model codes
- Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 2050001
- Firm city
- Mettawa
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28