Home / Recalls / Baxter Healthcare Corporation / Z-3084-2024

Z-3084-2024 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
August 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,828,540 units

Product Description

Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device

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 Pattern

Worldwide distribution.

Code Information

UDI/DI 00085412475806, Lot Numbers: 803808 and lower

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