Recall Z-1752-2013— Baxa Corporation
Class II · Terminated
Class II FDA medical device recall by Baxa Corporation, initiated 2013-06-04, terminated 2015-10-16. It names one FDA 510(k) clearance: K002705. Product: ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.. 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..
- Recalling firm
- Baxa Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-04
- Terminated
- 2015-10-16
- Firm location
- Englewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.