ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
This recall has been terminated (originally issued July 18, 2013).
- Company
- Baxa Corporation
- Recall Initiated
- June 4, 2013
- Posted
- July 18, 2013
- Terminated
- October 16, 2015
- Recall Number
- Z-1752-2013
- Quantity
- 753 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
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
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Lot / Code Info
ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Root Cause
Nonconforming Material/Component
Action Taken
On 6/04/13, customers were notified by 1st class mailing with mitigating instructions including reminding customers that the battery failure results in a failure of the ExactaMix system to alert the user to replace the disposable set after 24 hours of use. Users should not rely on the alert to trigger the daily replacement of disposable sets. Users should also confirm the correct time and date at the setup of each use. If the compounder displays an incorrect time and date, customers are to contact Baxter Technical Support.