FDA Device recall Z-1019-2022
Flo-Thru Intraluminal Shunt
- FDA Device
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Flo-Thru Intraluminal Shunt by Baxter Healthcare, citing there is a potential for foreign matter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1019-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-01 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | AL, CA, KY, NY, OR, PA, TX |
Product
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Reason
There is a potential for foreign matter.
Identifiers
| code_info | Product Code: FT12150; Lot: SP21J21-1584173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2022%22
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