Notice Regarding BAXJECT® II Reconstitution Devices

Takeda has issued a letter addressing a potential concern regarding certain BAXJECT® II reconstitution devices produced by Baxter between October 2021 and January 2022 for use with RECOMBINATE™ and RIXUBIS® in the U.S. Takeda notified the FDA of plastic particle reports near the luer port of the BAXJECT II device, emphasizing that no adverse events have been attributed to the device. While the quality of RECOMBINATE and RIXUBIS is unaffected, Takeda is working with the FDA to determine the best course of action. Patients are advised to continue preparing and administering the products with existing BAXJECT II devices according to instructions, ensuring they are particle-free. Takeda can be contacted for any related inquiries, including adverse event reporting.

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