Reported Jan 17, 2024 · Ongoing
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes
24 of 24 products
| Model / number | Product as published |
|---|---|
50100 | 12MM, 1.00 MM GLOBAL |
50150 | 12MM, 1.50 MM GLOBAL |
50175 | 12MM, 1.75 MM GLOBAL |
50200 | 12MM, 2.00 MM GLOBAL |
50225 | 12MM, 2.25 MM GLOBAL |
50250 | 12MM, 2.50 MM GLOBAL |
50275 | 12MM, 2.75 MM GLOBAL |
50300 | 12MM, 3.00 MM GLOBAL |
50350 | 12MM, 3.50 MM GLOBAL |
50400 | 12MM, 4.00 MM GLOBAL |
60100 | 30MM, 1.00 MM GLOBAL |
60175 | 30MM, 1.75 MM GLOBAL |
60275 | 30MM, 2.75 MM GLOBAL |
60300 | 30MM, 3.00 MM GLOBAL |
60350 | 30MM, 3.50 MM GLOBAL |
50125 | 12MM, 1.25 MM GLOBAL |
50450BIOS | 12MM, 4.50 MM GLOBAL |
60125BIOS | 30MM, 1.25 MM GLOBAL |
60150BIOS | 30MM, 1.50 MM GLOBAL |
60200BIOS | 30MM, 2.00 MM GLOBAL |
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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