FDA-Device2013-07-24Class II

ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

Baxa Corporation
Hazard

Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

Sold states
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Affected count
753 units
Manufactured in
9540 Maroon Cir Unit 400, N/A, Englewood, CO, United States
Products
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1752-2013

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