Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

Recall date

August 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3085-2024

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device