Baxter Healthcare Corporation recalls Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anast

Recalled May 11, 2022 · FDA recall Z-1019-2022 · Baxter Healthcare

Hazard

There is a potential for foreign matter. · FDA Class II

Units

300 devices

Sold at

Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

Description

There is a potential for foreign matter.

Product

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Manufacturer(s)

Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →