FDA-Device2024-09-25Class I
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation
Hazard
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Sold states
Worldwide distribution.
Affected count
5,828,540 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3084-2024Don't want to check this manually?
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