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Baxter advises customers to stop using Baxject II device for mixing Aralast NP; particles reported in solution, but no safety issue
Baxter is advising customers to discontinue use of the Baxject II Hi-Flow device used to mix Aralast NP into an IV solution before use.
Aralast NP is an augmentation therapy, made from purified human blood plasma and used to treat Alpha-1 Antitrypsin Deficiency.
Baxter says the action is being taken as a precautionary measure after the company received reports that particles have been observed in the Aralast solution when the Baxject device is used to mix Aralast NP.
Baxter says no safety issues are involved, and there has been no increase in either severity or nature of adverse events being reported by customers using Aralast NP.
Baxter is advising all customers to discard all Baxject II devices. Customers are asked to call Baxter Customer Service at 800-423-2090 and request free double-ended transfer needles to mix the product. These are the same transfer needles previously packaged with Aralast NP.
Baxter has notified the FDA of this action.
