DuraSeal Dural Sealant
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
DuraSeal Dural Sealant |
60554149 |
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
Integra Lifesciences Corporation Also Dba Integra Neurosciences
1100 Campus Rd., Princeton, New Jersey, United States, 08540
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