EXACTAMIX 1200 Compounder — Class II medical device recall Z-1963-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-07-09, distributed nationwide. If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush
| Recall number | Z-1963-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-06-10 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2017-02-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,758 |
| Reason classes | software |
| Model numbers | 1200-DX, 1200-DXR, 1200-DY, 1200-DYR, 2400-DX, 2400-DY, 2400-DYR, 2400-DYX |
Product
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
Reason for recall
If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
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-1963-2014. 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.