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Recall Observatory FDA recall evidence

Device 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.

Z-1963-2014

June 10, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 68506
Status
Terminated
Classification
Class II
Quantity
1758
Official record key
device-enforcement:Z-1963-2014

Official wording

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.

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

Distribution pattern: US Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software. It could result in the original UI remaining in the tube which could