FDA: Baxa customers no longer using recalled mixing software

October 1, 2007

Baxa replaces malfunctioning IV mixing software

Customers of Baxa Corp. affected by a recall of the company's Exacta-Mix 2400 Operating Software Pharmacy Compound System are no longer using the product, the FDA reported. A malfunction of version 1.07 of the software prompted the agency to recall the product, which is used in hospital pharmacies to add and mix various ingredients into an IV solution. The software malfunction allowed as much as an extra 50 ml of an ingredient to be added to the IV solution—which could be a deadly amount, particularly in newborns. The FDA notified Baxa customers by telephone of the software error on June 27 and also sent customers a faxed or e-mailed letter detailing the malfunction. Customers were given instructions to follow to prevent additional volume from being added to IV bags and received an express-mail letter reinforcing the importance of the recall. The FDA said Baxa distributed 32 updated software units to 14 U.S. customers and one foreign customer between June 4 and June 25.

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