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

Products covered by this recall
#Product as published
150100
250125
350150
450175
550200
650225
750250
850275
950300
1050350
1150400
1250450BIOS
1360100
1460125BIOS
1560150BIOS
1660175
1760200BIOS
1860225BIOS
1960250BIOS
2060275
Lot codes and dates

24 of 24 products

Products covered by this recall
#BarcodesProduct as published
10008541253259250100, UDI/DI 00085412532592
20008541253268450125, UDI/DI 00085412532684
30008541253260850150, UDI/DI 00085412532608
40008541253269150175, UDI/DI 00085412532691
50008541253243150200, UDI/DI 00085412532431
60008541253244850225, UDI/DI 00085412532448
70008541253245550250, UDI/DI 00085412532455
80008541253246250275, UDI/DI 00085412532462
90008541253247950300, UDI/DI 00085412532479
100008541253248650350, UDI/DI 00085412532486
110008541253249350400, UDI/DI 00085412532493
120008541253250950450BIOS, UDI/DI 00085412532509
130008541253251660100, UDI/DI 00085412532516
140008541253211060125BIOS, UDI/DI 00085412532110
150008541253212760150BIOS, UDI/DI 00085412532127
160008541253213460175, UDI/DI 00085412532134
170008541253214160200BIOS, UDI/DI 00085412532141
180008541253215860225BIOS, UDI/DI 00085412532158
190008541253252360250BIOS, UDI/DI 00085412532523
200008541253261560275, 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.