Z-2826-2018Class I

The Tri-Flo Subglottic Suction System

Name: Z-2826-2018 The Tri-Flo Subglottic Suction System
Creator: Vyaire Medical
Published: 2018-06-20
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2018-06-20 / Terminated / root cause: manufacturing process

FDA source

Vyaire Medical began a recall of The Tri-Flo Subglottic Suction System on 2018-06-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2826-2018
Classification: Class I
Status: Terminated
Initiated: 2018-06-20
Posted: 2018-08-21
Terminated: 2020-07-28
Recalling firm: Jaeger Medical GmbH
Product: The Tri-Flo Subglottic Suction System
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 2150 Units Total
Distribution: Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Product codes and lots: Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2826-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2826-2018	Class I	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-21

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)