FDAFDA · Food and drugs·Recall number Z-1752-2013
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Published July 24, 2013 · Recall initiated: June 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxa Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
- Lot
- ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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