FDA Medical Device Recalls (openFDA)
Baxa Corporation: ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
- Recall number
- Z-1752-2013
- Recalling firm
- Baxa Corporation
- Product
- ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
- Status
- Terminated
- Initiated
- 2013-06-04
- Posted
- 2013-07-18
- Terminated
- 2015-10-16
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 753 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
- Lot, serial or model codes
- ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
- 510(k) numbers
- ["K002705"]
- PMA numbers
- not on file
- Product code
- LHI
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28