FDA Device recall Z-0663-2024
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL by Baxter Healthcare, citing cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0663-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT12250, 2.50 GLOBAL; h) Product Code FT12275, 2.75 GLOBAL; i) Product Code FT12300, 3.00 GLOBAL
Reason
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Identifiers
| code_info | All serial numbers, a) Product Code FT12100, UDI/DI 85412532431; b) Product Code FT12125, UDI/DI 85412532448; c) Pro…All serial numbers, a) Product Code FT12100, UDI/DI 85412532431; b) Product Code FT12125, UDI/DI 85412532448; c) Product Code FT12150, UDI/DI 85412532455; d) Product Code FT12175, UDI/DI 85412532462; e) Product Code FT12200, UDI/DI 85412532479; f) Product Code FT12225, UDI/DI 85412532486; g) Product Code FT12250, UDI/DI 85412532493; h) Product Code FT12275, UDI/DI 85412532509; i) Product Code FT12300, UDI/DI 85412532516 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0663-2024%22
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