Health product recall

Synovis Intravascular Probes, Shunts and Patches

Last updated

Summary

Product
Synovis Intravascular Probes, Shunts and Patches
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Synovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc

2575 University Avenue. W., St-Paul, Minnesota, United States, 55114-1024

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74667