Recall Monitor
Health Products

DuraSeal Dural Sealant

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: DuraSeal Dural Sealant
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
DuraSeal Dural Sealant60554149
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

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