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  5. Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error
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Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error

Please be aware, this recall is a correction, not a product removal.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

Device Use

The ExactaMix Pro is a pharmacy system that makes sterile solutions based on what the user needs. The Pro 1200 can use up to 12 ingredients, and the Pro 2400 can use up to 24. These devices are most commonly used to make sterile solutions for different medical uses, like nutrition, heart procedures, pain relief, and kidney therapy.

Reason for Recall

Baxter Healthcare is recalling the ExactaMix Pro 1200 and the Pro 2400 because of a software error that can cause more ingredients than needed to be added to the final solution. An issue was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature, potentially resulting in extra ingredients being delivered. Baxter is working on a software update to fix this issue, and it's expected to be available in March 2024.

The use of the affected product may cause serious adverse health consequences, including permanent impairment, life-threatening illness, and death.

There have been no reported injuries and no reports of death.

Who May be Affected

  • Pharmacies and healthcare professionals that prepare sterile solutions using the ExactaMix Pro 1200 or Pro 2400.
  • People who receive sterile solutions prepared using the ExactaMix Pro 1200 or Pro 2400.

What to Do

On December 22, 2023, Baxter Healthcare Corporation sent all affected customers an Urgent Medical Device Correction.

The letter requested customers to:

  • Avoid using the "Use Some Overfill" feature until further notice from Baxter and use a different container when prompted about ingredient depletion.
  • If the “Use Some Overfill” feature is accidentally used, follow these steps:
    • Only use the feature once when an ingredient is depleted.
    • Enter a volume of overfill that is less than the remaining volume specified in the Swap Container window.
    • Check the MixCheck report, ensuring that all ingredient deliveries with overfill match the expected volumes. Compare each ingredient's dispensed and ordered volume and verify the final total volume.
    • If redundant ingredient delivery is observed in the MixCheck report, discard the bag.
  • Always check the final MixCheck report as instructed in the ExactaMix Pro Operator Manual.
    • Refer to pages 167-171 in the ExactaMix Pro 2400 Operator Manual and pages 164-168 in the ExactaMix Pro 1200 Operator Manual for details on this feature.
  • Wait for a Baxter representative to contact the facility once the software upgrade becomes available.
  • Acknowledge receipt of this letter by responding on the customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com.
  • Forward a copy of this communication to other facilities or departments where this product was distributed.

Contact Information

Customers in the U.S. with questions about this recall should contact Baxter Global Technical Services at 1-800-678-2292.

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.


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