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 |
Flo-Thru Intraluminal Shunt |
All lots within expiry. |
FT-12100 |
Supple Peri-Guard Repair Patch |
All lots within expiry. |
PC-0608SN |
Flo-Rester Internal Vessel Occluder |
All lots within expiry. |
50200 |
Vascular Probe Intravascular Probe |
All lots within expiry. |
7152025ES |
Peri-Guard Repair Patch |
All lots within expiry. |
PC-1016N |
Vascu-Guard Vascular Repair Patch |
All lots within expiry. |
VG-0106N |
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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