Medical Device Recall: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation · August 20, 2024
Reason for Recall
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.
Distribution
Worldwide distribution.
Quantity Affected
2,140,046 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3085-2024
Status: ongoing
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