FDAFDA · Food and drugs·Recall number Z-1019-2022
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.
Published May 11, 2022 · Recall initiated: April 1, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for foreign matter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
- Lot
- Product Code: FT12150; Lot: SP21J21-1584173
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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