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Codman® surgical strips and patties x-ray detectable

Official notice

24 Oct 2024

Last checked

24 Oct 2024

Medium riskHealth Canada

An official Health Canada notice concerns Codman® surgical strips and patties x-ray detectable. During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods. Consequently, while the endotoxin levels identified were higher than expected, the possibility of adverse health consequences actually occurring remains remote. Recall start date: October 7, 2024 Published 2024-10-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76389

Official notice

2024-10-24

The hazard

During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods. Consequently, while the endotoxin levels identified were higher than expected, the possibility of adverse health consequences actually occurring remains remote. Recall start date: October 7, 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

76389

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Affected products

Product 1

Affected products - CODMAN® Surgical Strips X-Ray Detectable, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 80-1456 80-1455 80-1449 80-1450 80-1451 80-1452 80-1454 80-1457 80-1453

Product 2

Affected products - CODMAN® Surgical Patties X-Ray Detectable, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 80-1398 80-1399 80-1401 80-1407 80-1408 80-1397 80-1400 80-1404 80-1406 80-1396 80-1402 80-1403 80-1409

Risk / hazard

During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods. Consequently, while the endotoxin levels identified were higher than expected, the possibility of adverse health consequences actually occurring remains remote. Recall start date: October 7, 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: Integra Lifesciences Production, Codman® Surgical Strips And Patties X-ray Detectable.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76389

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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