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Baxter healthcare hemostatic products

Official notice

1 Dec 2023

Last checked

1 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Baxter healthcare hemostatic products. 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

74665

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

74665

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Affected products

Product 1

Affected products - Floseal Hemostatic Matrix, Lot or serial number - All lots within expiry., Model or catalog number - 1505114 1505116

Product 2

Affected products - Hemopatch Sealing Hemostat, Lot or serial number - All lots within expiry., Model or catalog number - 1506256 1506257 1506253

Product 3

Affected products - Coseal Surgical Sealant, Lot or serial number - All lots within expiry., Model or catalog number - 934070 934071

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

Manufacturer

Not provided

Phone

Not provided

Brand: Baxter Healthcare, Baxter Healthcare Hemostatic.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74665

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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