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Synovis intravascular probes, shunts and patches

Official notice

1 Dec 2023

Last checked

1 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Synovis intravascular probes, shunts and patches. 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 Published 2023-12-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74667

Official notice

2023-12-01

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74667

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Affected products

Product 1

Affected products - Vascular Probe Intravascular Probe, Lot or serial number - All lots within expiry., Model or catalog number - 7081520 7081015 7451015

Product 2

Affected products - Flo-Thru Intraluminal Shunt, Lot or serial number - All lots within expiry., Model or catalog number - FT-12100 FT-12125 FT-12150 FT-12175

Product 3

Affected products - Supple Peri-Guard Repair Patch, Lot or serial number - All lots within expiry., Model or catalog number - PC-0608SN PC-0814SN PC-1016SN PC-0404SN

Product 4

Affected products - Flo-Rester Internal Vessel Occluder, Lot or serial number - All lots within expiry., Model or catalog number - 50200 50100 50125 50175 50150

Product 5

Affected products - Vascular Probe Intravascular Probe, Lot or serial number - All lots within expiry., Model or catalog number - 7152025ES 7151015ES

Product 6

Affected products - Peri-Guard Repair Patch, Lot or serial number - All lots within expiry., Model or catalog number - PC-1016N PC-0404N PC-0608N PC-0814N PC-1225N

Product 7

Affected products - Vascu-Guard Vascular Repair Patch, Lot or serial number - All lots within expiry., Model or catalog number - VG-0106N VG-0110N VG-0209N VG-0108N

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Synovis Life A Subsidiary Of Baxter, Synovis Intravascular Probes Shunts And Patches.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74667

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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