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?
24 of 24 products
| # | Product as published |
|---|---|
| 1 | 50100 |
| 2 | 50125 |
| 3 | 50150 |
| 4 | 50175 |
| 5 | 50200 |
| 6 | 50225 |
| 7 | 50250 |
| 8 | 50275 |
| 9 | 50300 |
| 10 | 50350 |
| 11 | 50400 |
| 12 | 50450BIOS |
| 13 | 60100 |
| 14 | 60125BIOS |
| 15 | 60150BIOS |
| 16 | 60175 |
| 17 | 60200BIOS |
| 18 | 60225BIOS |
| 19 | 60250BIOS |
| 20 | 60275 |
- Lot codes and dates
24 of 24 products
Products covered by this recall # Barcodes Product as published 1 0008541253259250100, UDI/DI 00085412532592 2 0008541253268450125, UDI/DI 00085412532684 3 0008541253260850150, UDI/DI 00085412532608 4 0008541253269150175, UDI/DI 00085412532691 5 0008541253243150200, UDI/DI 00085412532431 6 0008541253244850225, UDI/DI 00085412532448 7 0008541253245550250, UDI/DI 00085412532455 8 0008541253246250275, UDI/DI 00085412532462 9 0008541253247950300, UDI/DI 00085412532479 10 0008541253248650350, UDI/DI 00085412532486 11 0008541253249350400, UDI/DI 00085412532493 12 0008541253250950450BIOS, UDI/DI 00085412532509 13 0008541253251660100, UDI/DI 00085412532516 14 0008541253211060125BIOS, UDI/DI 00085412532110 15 0008541253212760150BIOS, UDI/DI 00085412532127 16 0008541253213460175, UDI/DI 00085412532134 17 0008541253214160200BIOS, UDI/DI 00085412532141 18 0008541253215860225BIOS, UDI/DI 00085412532158 19 0008541253252360250BIOS, UDI/DI 00085412532523 20 0008541253261560275, UDI/DI 00085412532615 - Amount recalled
- 83971 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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