Recall Z-1019-2022 ยท DXC Clamp, Vascular
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.
| Date | Apr 29, 2022 (initiated Apr 1, 2022) |
| Status | Terminated |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981624 | FLO-THRU Bio-Vascular, Inc., Aug 4, 1998 |