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.
FDA Recall Z-1019-2022 · Posted 2022-04-29
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeDXC
Date Initiated2022-04-01
Date Terminated2026-07-10
Product Quantity300 devices
Reason for Recall
There is a potential for foreign matter.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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