Baxter Healthcare Corporation Recall 95192
Description: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation Recall 95192 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3085-2024 |
| Event ID | 95192 |
| Event Description | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 2,140,046 units |
| Recall 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. |
| Device Classification | 20240925 |
| Device Code Info | UDI/DI 00085412475813, Lot Numbers: 803807 and lower |
| Center Classification Date | 20240919 |
| Recall Initiation Date | 20240820 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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