Baxter EXACTAMIX Inlet — Class I medical device recall Z-3083-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-09-25. Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated C
| Recall number | Z-3083-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-08-20 |
| Classified | 2024-09-19 |
| Reported by FDA | 2024-09-25 |
| Quantity | 1,548,782 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 00085412475790 |
| Lot numbers | 803799 |
| Model numbers | H938174 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3083-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.