Recall of Certain Compounding Device Inlets Potentially Used in Veterinary Settings

CVM is sharing these announcements because these products may be used in veterinary settings.

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

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Reason for Updates to Use Instructions

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 use of affected product may cause serious adverse health consequences, including a blood clot in the lungs (pulmonary embolism), stroke, damage to small blood vessels and organs, other serious injuries, and death.

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

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