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Health Canada Medical devices

Ionostar Plus and Ionolux

Issued February 2, 2024
Issue
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionostar Plus. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the Instructions For Use (IFU) is not possible. The reactive component in the incorrect plungers contains small amounts of BHT and Methacrylate. These ingredients are not listed in the IFU. Recall Start Date: January 23, 2024
Hazard description
Labelling and packaging
Product
Product name
Ionostar Plus and Ionolux
Reference
ID
RA-75003