The Exacta-Mix 2400 compounding system — Class II medical device recall Z-1570-2022
Ongoing recall by Baxter Healthcare Corporation, reported 2022-08-31, distributed nationwide. There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
| Recall number | Z-1570-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-07-14 |
| Classified | 2022-08-24 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BR, CA, CH, CO, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, IE, IL, IT, KR, KW, NL, OM, PA, PL, PT, QA, RO, SA, SE, SI, TR, TW, UY |
| Quantity | 448,960 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00085412477183 |
| Lot numbers | 60316024 |
Product
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Reason for recall
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
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-1570-2022. 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.