Company:Baxter Healthcare Corp.
Date of Enforcement Report: 7/9/2014
Class lI:
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. Recall Number Z-1963-2014
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.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp, Deerfield, IL. on 6/10/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1758
DISTRIBUTION
Nationwide
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