Z-1019-2022Class II

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood...

Name: Z-1019-2022 Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood...
Creator: Baxter Healthcare Corporation
Published: 2022-04-01
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-04-01 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary... on 2022-04-01. FDA classified it as Class II and gives the reason as "There is a potential for foreign matter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1019-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-01
Posted: 2022-04-29
Terminated: 2026-07-10
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.
Product code: DXC Clamp, Vascular
Reason for recall: There is a potential for foreign matter.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Product Code: FT12150; Lot: SP21J21-1584173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-04-29

Product code DXC

K981624Class IIFlo-ThruBio-Vascular, Inc. / cleared 1998-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)