FDA Medical Device Recalls (openFDA)
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 number
- Z-1019-2022
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Status
- Terminated
- Initiated
- 2022-04-01
- Posted
- 2022-04-29
- Terminated
- 2026-07-10
- Reason
- There is a potential for foreign matter.
- Root cause
- Process control
- 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.
- Quantity
- 300 devices
- Distribution
- 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, serial or model codes
- Product Code: FT12150; Lot: SP21J21-1584173
- 510(k) numbers
- ["K981624"]
- PMA numbers
- not on file
- Product code
- DXC
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28