FDA Device recall Z-2826-2018
The Tri-Flo Subglottic Suction System
- FDA Device
- Class I
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class I recall of The Tri-Flo Subglottic Suction System by Vyaire Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2826-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-06-20 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vyaire Medical |
| Distribution | AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI |
Product
The Tri-Flo Subglottic Suction System
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.
Identifiers
| code_info | Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2826-2018%22
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