Device product
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Z-3083-2024
Product summary
- Event
- Event 95192
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,548,782 units
- Official record key
device-enforcement:Z-3083-2024
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 00085412475790, Lot Numbers: 803799 and lower
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter