Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anast
FDA device recall Z-1019-2022 · posted 2022-04-29 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There is a potential for foreign matter.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 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
- Date initiated
- 2022-04-01
- Date posted
- 2022-04-29
- Date terminated
- 2026-07-10
- Location
- Deerfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLO-THRU (K981624) | Bio-Vascular, Inc. | 1998-08-04 |