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Duraseal dural sealant
Official notice
26 Mar 2025
Last checked
26 Mar 2025
An official Health Canada notice concerns Duraseal dural sealant. Through an internal investigation, it was determined that there is no age restriction statement on the Canadian IFU for the DuraSeal Dural Sealant system. Upon review of the IFU and supporting evidence, it was determined that the following age restriction should be included in the IFU: "Precaution: do not use in patients younger than 13 years of age." Recall Start Date: March 13, 2025 Published 2025-03-26.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77181
Official notice
2025-03-26
The hazard
The hazard
Through an internal investigation, it was determined that there is no age restriction statement on the Canadian IFU for the DuraSeal Dural Sealant system. Upon review of the IFU and supporting evidence, it was determined that the following age restriction should be included in the IFU: "Precaution: do not use in patients younger than 13 years of age." Recall Start Date: March 13, 2025
How to check if you're affected
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
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Integra Lifesciences Also Dba Integra Neurosciences, Duraseal Dural Sealant.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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