EM2400 Exactamix Valve Set

Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position, resulting in unintended ingredient transfer into the compounded admixture. This leak would be most noticeable when the Exactamix compounder is pumping and moving fluid through the common fluid pathway.  The affected product has been distributed since 11/28/2021 in Canada. 

Recall start date: July 18, 2022