# FDA recall Z-1522-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-02-22.

## 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-Rester Disposable Internal Vessel Occluder, Item Numbers:  a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

## 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

Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.

## Key facts

- **Recall number:** Z-1522-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-22
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2024

## Citation

> AI Analytics. FDA recall Z-1522-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1522-2024. Source: US FDA. Licensed CC0.

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