Baxter Healthcare Corporation The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

Recommended Action

Per FDA guidance

Baxter issued an URGENT DEVICE CORRECTION notice by mail on 07/14/2022. Baxter sent a follow-up notice dated 6/28/2023, stating Customers may return to using all 24 ports on their compounders when using newly manufactured EXACTAMIX 2400 Valve Sets (product code H938724, lot 60459942 and sequentially higher). Contact Baxter Technical Support M-F 8am-7pm ET at 800-678-2292 for help establishing/restoring a 24-port configuration for compounding, if not on drop-down menu. Lot numbers 60459941 and lower MUST use only 20 ports, omitting ports 1-4. For these sets: Baxter Technical Service added new compounder configurations for temporary use that omit the use of ports 1-4, and only use ports 5-24 for the ingredients on your compounder. For valve sets Lot numbers 60459941 and lower, a maximum of 20 ingredients can be pumped via the compounder. Observe the pumping process to monitor for leaks and unintended white or yellow discolored solution pumping through the valve set tubing into the final container. If unintended transfer of solutions from ports 1-4 are seen, abort the compounding process, discard the final container, replace the valve set, and report the incident to Baxter Product Surveillance. Depending on the ingredients on ports 1-4 and the respective volumes, customers may be able to add these ingredients as manual additions. Consider the type of ingredient to avoid precipitation based on the sequence of those additions. Continue to follow your institutional policy and procedures for compounding. The use of a 1.2-micron filter is a recommended best practice by ASPEN when administering all parenteral nutrition formulations.