Health product recall

Em2400 Exactamix Valve Set

Last updated

Summary

Product
Em2400 Exactamix Valve Set
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Em2400 Exactamix Valve Set

Lot 60316024 and higher

H938724

Issue

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

Additional information

Details
Original published date: 2022-07-27
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Baxter Healthcare Corporation

1 Baxter Parkway, Deerfield, Illinois, United States, 60015

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64398