Z-1963-2014 Class II Terminated
FDA device recall Z-1963-2014 was initiated by Baxter Healthcare Corp. on Jun 10, 2014 and is designated Class II. 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… The recall status is terminated (terminated Feb 22, 2017). Affected quantity: 1758.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 9, 2014
- Initiation Date
- Jun 10, 2014
- Termination Date
- Feb 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1758
Product Description
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.
Distribution Pattern
US Nationwide
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1963-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026