FDA Device recall Z-1963-2014
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR by Baxter Healthcare, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1963-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-10 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1963-2014%22
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