Recall Z-3085-2024 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
| Date | Sep 19, 2024 (initiated Aug 20, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/20/2024 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Disseminate this information to anyone who may interact with the ExactaMix and ExactaMix Pro compounders and the products they produce (Pharmacy and Clinical Staff). 2. Pharmacy Staff: Inspect the inlets before use, including the inlet primary packaging, tubing, connectors, and spikes. Perform the inspection in accordance with the enclosed instructions. o If parti |
| Quantity | 2,140,046 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 Baxa Corp., Mar 28, 2001 |