FDA Enforcement
Class I
Ongoing
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Recall: Z-3083-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3083-2024
- Event ID
- 95192
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- August 20, 2024
- Classification Date
- September 19, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
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 Info
UDI/DI 00085412475790, Lot Numbers: 803799 and lower
Distribution
Worldwide distribution.
Quantity
1,548,782 units