DuraSeal Dural Sealant
Last updated
Summary
Product
DuraSeal Dural Sealant
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| DuraSeal Dural Sealant | 60554149 60564284 60494436 60500849 60585323 60510579 60409924 60415721 60483206 | 209005 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Integra Lifesciences Corporation Also Dba Integra Neurosciences
1100 Campus Rd., Princeton, New Jersey, United States, 08540
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-77181
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