Recall Z-1963-2014
Baxter Healthcare Corp. · initiated June 10, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Software design
Action taken
An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
Details
- Recall number
- Z-1963-2014
- Initiated
- June 10, 2014
- Posted by FDA
- July 1, 2014
- Terminated
- February 22, 2017
- Product code
- LHI – Set, I.V. Fluid Transfer
- Quantity
- 1758
- Distribution
- US Nationwide
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL