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Recall Observatory FDA recall evidence

Device product

Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device

Z-3082-2024

August 20, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95192
Status
Ongoing
Classification
Class I
Quantity
3,580,283 units
Official record key
device-enforcement:Z-3082-2024

Official wording

Reason: 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.

Code information: UDI/DI 00085412475783, Lot Numbers: 803806 and lower

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter