# FDA recall Z-0663-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-12-06.

## 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 for recall

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).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0663-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-06
- **Report date:** 2024-01-17

- **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-0663-2024

## Citation

> AI Analytics. FDA recall Z-0663-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0663-2024. Source: US FDA. Licensed CC0.

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