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Recall Observatory FDA recall evidence

Device product

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

Z-1752-2013

June 04, 2013

Class II

Product summary

Firm
Baxa Corporation
Event
Event 65215
Status
Terminated
Classification
Class II
Quantity
753 units
Official record key
device-enforcement:Z-1752-2013

Official wording

Reason: 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.

Code information: ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.