Baxter ExactaMix Recalled for Over-Delivery of Ingredients Due to Software Error

Due to an overfill feature in mixing medical ingredients potentially leading to an “over-delivery” and adverse health consequences, Baxter Healthcare has recalled for product correction its ExactaMix Pro 1200 and Pro 2400 pharmacy system compounding devices.

The FDA has identified the action as a Class I recall.

The ExactaMix Pro 1200 and Pro 2400 can accommodate up to 12 and 24 ingredients respectively and are primarily used by pharmacies and healthcare professionals to make sterile solutions for pain relief, heart procedures, kidney therapy and nutrition. Due to an error in compounders with software versions 2.0.8 and 2.1.8, using the “Use Some Overfill” feature could result in redundant ingredient delivery to the automated devices.

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