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Overseas-Registered Products Available for Cyclophosphamide and Ifosfamide Injection Shortages

Baxter Healthcare has notified TGA Australia that global supply constraints due to manufacturing issues are affecting Endoxan (cyclophosphamide) 2g and Holoxan (ifosfamide) 2g powder for injection vials. These medicines are used to treat various types of cancer, diseases of the immune system, and to prevent rejection of organ transplants. The shortages are expected to continue until the end of June 2026. TGA has approved the supply of multiple overseas-registered cyclophosphamide and ifosfamide injection products under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages.

Baxter Volara Single-Patient Use Circuits - Updated Instructions, Class I Recall

FDA has identified this Class I recall as the most serious type, involving updated instructions for Baxter Volara system single-patient use circuits rather than device removal. Baxter issued an Urgent Medical Device Correction letter on February 18 notifying affected customers of updated use instructions after four patients did not receive the Instructions for Use Addendum. The FDA is aware of seven serious injuries and no deaths related to this issue between May 30, 2022, and March 24, 2026. Risks include oxygen desaturation and barotrauma when the Volara device is used in-line with a ventilator in the home care environment.

Baxter Head Positioning Adapter Recall Type I

Baxter Corporation is recalling its Adapter For Head Positioning (Model 1739994) following identification that the device may become loose during patient positioning and unintentionally move when used with side rails of the upper back section H V U on Baxter operating tables. The recall affects three lot numbers—109943587, 109948552, and 109964961—and has been classified as Type I, the most serious recall category. Healthcare facilities using this device should contact Baxter for further information and follow any supplementary instructions issued by the firm.