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Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components
Baxter Healthcare Corporation is updating use instructions for Automated Compounding Device Inlets (disposable inlet) used with the ExactaMix and ExactaMix Pro due to increased reports of particulate matter found within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use. This issue only affects the disposable inlets and does not affect the ExactaMix or ExactaMix Pro compounder devices.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with questions about this recall should contact Baxter Healthcare Center for Service at 888-229-0001.
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