CLASS I Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
The Tri-Flo Subglottic Suction System recalled by Vyaire Medical
Vyaire Medical is recalling The Tri-Flo Subglottic Suction System, distributed in 18 states. The recall was initiated on 20 Jun 2018 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2826-2018
- FDA event ID
- 80508
- Recalling firm
- Vyaire Medical, Mettawa, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Jun 2018
- FDA classified
- 21 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Jun 2018 | Recall initiated by company | |
| 21 Aug 2018 | Classified by FDA | +62 days |
| 29 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
The Tri-Flo Subglottic Suction System
Where it was distributed
Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
ArizonaCaliforniaConnecticutFloridaGeorgiaIowaIllinoisIndianaMassachusettsMarylandMinnesotaNew JerseyOhioOklahomaSouth DakotaTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
Where was it sold?
Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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