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Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis

Takeda has decided to voluntarily replace BAXJECT II and BAXJECT II Hi-Flow reconstitution devices produced at Takeda’s contract device manufacturer between October 2021 and January 2022. This is a precautionary measure and is due to the potential presence of particulate matter in the luer port of the device. The issue is linked to the device and there is no quality issue with the treatment product or any other components in the package. No adverse events reported in Takeda’s global safety databases were attributable to the presence of particles in BAXJECT II/BAXJECT II Hi-Flow devices.

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Takeda has identified the countries that received the impacted batches and is working with regional, national and local health authorities to take corrective actions, which may vary by country. In agreement with the European Medicines Agency, Takeda will work with health authorities in the identified countries in Europe to provide replacement BAXJECT II and BAXJECT II Hi-Flow reconstitution devices to healthcare professionals who have received devices from the impacted batches.

BAXJECT II and BAXJECT II Hi-Flow reconstitution devices contained in the listed batches should be discarded and the replacement devices should be used as instructed in the product information documentation.

To find out more, please click here. To read the statement provided by Takeda, click here. To read the statement provided by the European Haemophilia Consortium, please click here. To read the statement provided by the National Bleeding Disorders Foundation (NBDF), please click here.

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