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Biodesign® hiatal hernia graft

Official notice

19 Dec 2024

Last checked

19 Dec 2024

Medium riskHealth Canada

An official Health Canada notice concerns Biodesign® hiatal hernia graft. There is a discrepancy between the correct product shelf life versus the shelf life presented on the finished product labeling. The affected products expire prior to the expiration date printed on the product labeling. This creates the potential for devices to be used beyond their intended expiration date. Recall start date: December 10, 2024 Published 2024-12-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76722

Official notice

2024-12-19

The hazard

There is a discrepancy between the correct product shelf life versus the shelf life presented on the finished product labeling. The affected products expire prior to the expiration date printed on the product labeling. This creates the potential for devices to be used beyond their intended expiration date. Recall start date: December 10, 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

76722

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Affected products

Product 1

Affected products - Biodesign® Hiatal Hernia Graft, Lot or serial number - LB1579758, Model or catalog number - C-PHR-7X10-U

Risk / hazard

There is a discrepancy between the correct product shelf life versus the shelf life presented on the finished product labeling. The affected products expire prior to the expiration date printed on the product labeling. This creates the potential for devices to be used beyond their intended expiration date. Recall start date: December 10, 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

Manufacturer

Not provided

Phone

Not provided

Brand: Cook Biotech, Biodesign® Hiatal Hernia Graft.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76722

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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