Z-1752-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2013
- Initiation Date
- June 4, 2013
- Termination Date
- October 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 753 units
Product Description
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Code Information
ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.