Synovis Intravascular Probes, Shunts and Patches
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vascular Probe Intravascular Probe | All lots within expiry. | 7081520 7081015 7451015 |
| Flo-Thru Intraluminal Shunt | All lots within expiry. | FT-12100 FT-12125 FT-12150 FT-12175 |
| Supple Peri-Guard Repair Patch | All lots within expiry. | PC-0608SN PC-0814SN PC-1016SN PC-0404SN |
| Flo-Rester Internal Vessel Occluder | All lots within expiry. | 50200 50100 50125 50175 50150 |
| Vascular Probe Intravascular Probe | All lots within expiry. | 7152025ES 7151015ES |
| Peri-Guard Repair Patch | All lots within expiry. | PC-1016N PC-0404N PC-0608N PC-0814N PC-1225N |
| Vascu-Guard Vascular Repair Patch | All lots within expiry. | VG-0106N VG-0110N VG-0209N VG-0108N |
Issue
Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate content that does not align with the products' instructions for use (IFU). These products must be used by medical professionals while following the associated product IFUs to ensure they are used safely and effectively. Please discard all copies of this marketing brochure you may have received or downloaded starting in December 2021.
Recall Start Date: November 16, 2023
Additional information
Details
Synovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc
2575 University Avenue. W., St-Paul, Minnesota, United States, 55114-1024
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