# FDA recall Z-0656-2024

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

## Product

Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes:  a)	Product Code 50100:  12MM, 1.00 MM GLOBAL;   b)	Product Code 50150:  12MM, 1.50 MM GLOBAL;   c)	Product Code 50175:   12MM, 1.75 MM GLOBAL;   d)	Product Code 50200:   12MM, 2.00 MM GLOBAL;   e)	Product Code 50225:   12MM, 2.25 MM GLOBAL;   f)	Product Code 50250:   12MM, 2.50 MM GLOBAL;   g)	Product Code 50275:   12MM, 2.75 MM GLOBAL;   h)	Product Code 50300:   12MM, 3.00 MM GLOBAL;   i)	Product Code 50350:   12MM, 3.50 MM GLOBAL;   j)	Product Code 50400:   12MM, 4.00 MM GLOBAL;   k)	Product Code 60100:   30MM, 1.00 MM GLOBAL;   l)	Product Code 60175:   30MM, 1.75 MM GLOBAL;   m)	Product Code 60275:   30MM, 2.75 MM GLOBAL;   n)	Product Code 60300:   30MM, 3.00 MM GLOBAL;   o)	Product Code 60350:   30MM, 3.50 MM GLOBAL;   p)	Product Code 50125:   12MM, 1.25 MM GLOBAL;   q)	Product Code 50450BIOS:   12MM, 4.50 MM GLOBAL;   r)	Product Code 60125BIOS:   30MM, 1.25 MM GLOBAL;   s)	Product Code 601

## 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-0656-2024
- **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-0656-2024

## Citation

> AI Analytics. FDA recall Z-0656-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0656-2024. Source: US FDA. Licensed CC0.

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