Surgical Tools and Cardiovascular Specialty marketing brochures — Class II medical device recall Z-1523-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-04-24, distributed nationwide. The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Inte
| Recall number | Z-1523-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-02-22 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, HK, IE |
| Quantity | 112,760 units |
| UPC / GTIN / UDI-DI | 00085412532004, 00085412532011, 00085412532042, 00085412532059, 00085412532066, 00085412532073, 00085412532080, 00085412532097, 00085412532103 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1523-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.