Medical Advisory: Notice Regarding BAXJECT® II Reconstitution Devices

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Takeda has brought to our attention an issue with some BAXJECT® II reconstitution devices produced between October 2021 and January 2022 for use in conjunction with RECOMBINATE [Antihemophilic Factor (Recombinant)] and RIXUBIS® [Coagulation Factor IX (Recombinant)] in the U.S. First reported 16 August 2023.

Takeda notified the U.S. Food and Drug Administration (FDA) of reports of plastic particles originating near the luer port of the BAXJECT II device. All reported complaints to date were observed prior to administration, either when the luer port cap was removed as part of the preparation process or in the syringe after the drug was reconstituted. There have been no reported adverse events attributable to the BAXJECT II device to date. These particles reportedly are too large to transfer from the contaminated medication through the needle, tubing, and to the patient.

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