Baxter Healthcare Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: FT12150, Lot: SP21J21-1584173
Products Sold
Product Code: FT12150; Lot: SP21J21-1584173
Baxter Healthcare Corporation is recalling Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shun due to There is a potential for foreign matter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for foreign matter.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall communication was sentt to affected customers via U.S.P.S., first class mail on 04/01/2022. Customers are advised to: 1) Locate and return any unused affected product from your facility. The product code and lot number can be found on the individual product pouch or carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. Acknowledge receipt of this notification by completing a reply form on the customer portal.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026