Reported Apr 24, 2024 · Ongoing
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools…
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?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | FT12100 |
| 2 | FT12125 |
| 3 | FT12150 |
| 4 | FT12175 |
| 5 | FT12200 |
| 6 | FT12225 |
| 7 | FT12250 |
| 8 | FT12275 |
| 9 | FT12300 |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 00085412532004FT12100, UDI/DI 00085412532004 2 00085412532011FT12125, UDI/DI 00085412532011 3 00085412532042FT12150, UDI/DI 00085412532042 4 00085412532059FT12175, UDI/DI 00085412532059 5 00085412532066FT12200, UDI/DI 00085412532066 6 00085412532073FT12225, UDI/DI 00085412532073 7 00085412532080FT12250, UDI/DI 00085412532080 8 00085412532097FT12275, UDI/DI 00085412532097 9 00085412532103FT12300, UDI/DI 00085412532103 - Amount recalled
- 112760 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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