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Presource® kits containing codman® patties & strips© components produced by integra lifesciences

Official notice

21 Nov 2024

Last checked

21 Nov 2024

Medium riskHealth Canada
Watch Cardinal Health 200 Also Trading Cardinal Health

An official Health Canada notice concerns Presource® kits containing codman® patties & strips© components produced by integra lifesciences. Cardinal Health received communication from Integra Lifesciences, which recommended an assessment be completed for bulk-non-sterile surgical strips and patties due to potential endotoxin contamination. Presource® has completed its assessment related to this communication and determined customers may have received Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Based on the results of that completed assessment, Cardinal Health is issuing a field action event to over label Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Recall Start Date: November 11, 2024 Published 2024-11-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76556

Official notice

2024-11-21

The hazard

Cardinal Health received communication from Integra Lifesciences, which recommended an assessment be completed for bulk-non-sterile surgical strips and patties due to potential endotoxin contamination. Presource® has completed its assessment related to this communication and determined customers may have received Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Based on the results of that completed assessment, Cardinal Health is issuing a field action event to over label Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Recall Start Date: November 11, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76556

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Affected products

Product 1

Affected products - Cervical Disc Surgery, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SNE30HNCLM SNE30HNCLK SNE30HNCLL SNE30HNVOF

Product 2

Affected products - Facial Surgery Packs, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SBA30MFOCC SBA30MFOCA SBA30MFOCD SBA30MFOCB

Product 3

Affected products - Discectomy Pack, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SNE30DLCLM SNE30DLCLL SNE30DLVOH

Product 4

Affected products - Eye Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SEY30EYRVC SEY30EYRVA SEY30EYRVB

Product 5

Affected products - Basic Middle Ear Packs, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SEN30TYHMT SEN30TYHM2 SEN30TYHMU

Product 6

Affected products - Lumbar Discoidectomy Packs, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SOP30DLCBC SOP30DLCBD SOP30DLCBB

Risk / hazard

Cardinal Health received communication from Integra Lifesciences, which recommended an assessment be completed for bulk-non-sterile surgical strips and patties due to potential endotoxin contamination. Presource® has completed its assessment related to this communication and determined customers may have received Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Based on the results of that completed assessment, Cardinal Health is issuing a field action event to over label Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Recall Start Date: November 11, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Cardinal Health 200 Also Trading Cardinal Health, Presource® Kits Containing Codman® Patties Strips© Components Produced By Integra Lifesciences

Manufacturer

Not provided

Phone

Not provided

Brand: Cardinal Health 200 Also Trading Cardinal Health, Presource® Kits Containing Codman® Patties Strips© Components Produced By Integra Lifesciences.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76556

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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