Baxter Healthcare Corporation Recall 89897
Description: 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.
Baxter Healthcare Corporation Recall 89897 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1019-2022 |
| Event ID | 89897 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom |
| Quantity | 300 devices |
| Recall Reason | There is a potential for foreign matter. |
| Device Classification | 20220511 |
| Device Code Info | Product Code: FT12150; Lot: SP21J21-1584173 |
| Center Classification Date | 20220429 |
| Recall Initiation Date | 20220401 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Similar To |