Quick summary
Quick summary: Synovis Intravascular Probes, Shunts and Patches. Date: 2023-12-01.
Public recall detail
Synovis Intravascular Probes, Shunts and Patches
2023-12-01
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Synovis Intravascular Probes, Shunts and Patches. Date: 2023-12-01.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandSynovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc
ProductSynovis Intravascular Probes, Shunts and Patches
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-74667
Affected products
ProductVascular Probe Intravascular Probe
LotAll lots within expiry.
Model7081520 7081015 7451015
Serial numberAll lots within expiry.
DescriptionVascular Probe Intravascular Probe
ProductFlo-Thru Intraluminal Shunt
LotAll lots within expiry.
ModelFT-12100 FT-12125 FT-12150 FT-12175
Serial numberAll lots within expiry.
DescriptionFlo-Thru Intraluminal Shunt
ProductSupple Peri-Guard Repair Patch
LotAll lots within expiry.
ModelPC-0608SN PC-0814SN PC-1016SN PC-0404SN
Serial numberAll lots within expiry.
DescriptionSupple Peri-Guard Repair Patch
ProductFlo-Rester Internal Vessel Occluder
LotAll lots within expiry.
Model50200 50100 50125 50175 50150
Serial numberAll lots within expiry.
DescriptionFlo-Rester Internal Vessel Occluder
ProductVascular Probe Intravascular Probe
LotAll lots within expiry.
Model7152025ES 7151015ES
Serial numberAll lots within expiry.
DescriptionVascular Probe Intravascular Probe
ProductPeri-Guard Repair Patch
LotAll lots within expiry.
ModelPC-1016N PC-0404N PC-0608N PC-0814N PC-1225N
Serial numberAll lots within expiry.
DescriptionPeri-Guard Repair Patch
ProductVascu-Guard Vascular Repair Patch
LotAll lots within expiry.
ModelVG-0106N VG-0110N VG-0209N VG-0108N
Serial numberAll lots within expiry.
DescriptionVascu-Guard Vascular Repair Patch
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesSynovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc 2575 University Avenue. W., St-Paul, Minnesota, United States, 55114-1024
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74667
Background{}
CompaniesSynovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc 2575 University Avenue. W., St-Paul, Minnesota, United States, 55114-1024
AudiencesHealthcare
Source updated2023-12-01
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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