Z-3083-2024 Class I Ongoing
FDA device recall Z-3083-2024 was initiated by Baxter Healthcare Corporation on August 20, 2024 and is designated Class I. 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, H938… The recall status is ongoing. Affected quantity: 1,548,782 units.
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
- 1,548,782 units
Product Description
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, 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 00085412475790, Lot Numbers: 803799 and lower