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Surgimend and primafix endotoxin tests

Official notice

8 Jun 2023

Last checked

8 Jun 2023

Medium riskHealth Canada

An official Health Canada notice concerns Surgimend and primafix endotoxin tests. Based on an internal investigation, Integra Lifesciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Accordingly, we are recalling those products per the instructions in the attached customer letter. Recall start date: May 29, 2023 Published 2023-06-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73764

Official notice

2023-06-08

The hazard

Based on an internal investigation, Integra Lifesciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Accordingly, we are recalling those products per the instructions in the attached customer letter. Recall start date: May 29, 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

73764

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Affected products

Product 1

Affected products - Primatrix, Lot or serial number - 2104020 1905054 1707052 2005009 2107047

Risk / hazard

Based on an internal investigation, Integra Lifesciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Accordingly, we are recalling those products per the instructions in the attached customer letter. Recall start date: May 29, 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: Tei Biosciences, Surgimend And Primafix Endotoxin Tests.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73764

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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