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?

18 of 18 products

Products covered by this recall
#Product as published
17081015
27081015ES
37081520
47081520ES
57082025
67082025ES
77151015
87151015ES
97151520
107151520ES
117152025
127152025ES
137451015
147451015ES
157451520
167451520ES
177452025
187452025ES
Lot codes and dates

18 of 18 products

Products covered by this recall
#Product as published
17081015, UDI/DI00085412532554
27081015ES, UDI/DI00085412532646
37081520, UDI/DI00085412532561
47081520ES, UDI/DI00085412532653
57082025, UDI/DI00085412532578
67082025ES, UDI/DI00085412532660
77151015, UDI/DI00085412532585
87151015ES, UDI/DI00085412532677
97151520, UDI/DI00085412531908
107151520ES, UDI/DI00085412531915
117152025, UDI/DI00085412531922
127152025ES, UDI/DI00085412531939
137451015, UDI/DI00085412531946
147451015ES, UDI/DI00085412531953
157451520, UDI/DI00085412531960
167451520ES, UDI/DI00085412531977
177452025, UDI/DI00085412531984
187452025ES, UDI/DI00085412531991
Amount recalled
82020 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, 4:56 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.