FDA Device recall Z-1523-2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-21…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-21… by Baxter Healthcare, citing the Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1523-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-22 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,
Reason
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Identifiers
| code_info | Cardiovascular Specialty marketing brochures: Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-…Cardiovascular Specialty marketing brochures: Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version; Flo-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) FT12100, UDI/DI 00085412532004, b) FT12125, UDI/DI 00085412532011, c) FT12150, UDI/DI 00085412532042, d) FT12175, UDI/DI 00085412532059, e) FT12200, UDI/DI 00085412532066, f) FT12225, UDI/DI 00085412532073, g) FT12250, UDI/DI 00085412532080, h) FT12275, UDI/DI 00085412532097, i) FT12300, UDI/DI 00085412532103 |
|---|
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-1523-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.