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Baxter flo-thru, flo-rester and vascular probe

Official notice

8 Mar 2024

Last checked

8 Mar 2024

Medium riskHealth Canada

An official Health Canada notice concerns Baxter flo-thru, flo-rester and vascular probe. Baxter is issuing an important product information letter to communicate that the surgical tools education deck (ref ca-as20-220001) that may have been presented for the products listed, contains inaccurate content that does not align with the products' instructions for use (IFU). Recall start date: February 26, 2024 Published 2024-03-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75204

Official notice

2024-03-08

The hazard

Baxter is issuing an important product information letter to communicate that the surgical tools education deck (ref ca-as20-220001) that may have been presented for the products listed, contains inaccurate content that does not align with the products' instructions for use (IFU). Recall start date: February 26, 2024

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

75204

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Affected products

Product 1

Affected products - Flo-Thru Intraluminal Shunt, Lot or serial number - All lots., Model or catalogue number - FT-12100 FT-12125 FT-12200 FT-12150 FT-12175

Product 2

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

Product 3

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

Product 4

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

Risk / hazard

Baxter is issuing an important product information letter to communicate that the surgical tools education deck (ref ca-as20-220001) that may have been presented for the products listed, contains inaccurate content that does not align with the products' instructions for use (IFU). Recall start date: February 26, 2024

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, Baxter Flo-thru Flo-rester And Vascular Probe.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75204

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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