Z-1523-2024 Class II Ongoing
FDA device recall Z-1523-2024 was initiated by Baxter Healthcare Corporation on Feb 22, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 112760 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Feb 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112760 units
Product Description
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 for Recall
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).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1523-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026