ExactaMix 1200 and 2400 Compounders recallZ-1752-2013 · Baxa Corporation · initiated Jun 4, 2013
Class II Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxa Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1752-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 4, 2013
- Posted by the FDA
- Jul 18, 2013
- Recalling firm
- Baxa Corporation
- Quantity
- 753 units
- Product code
- LHI
- FDA submissions
- K002705
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Product description
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Code information (models, lots, serial numbers)
ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Other devices under the same FDA submission
7 devices cleared under K002705 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938175Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING3 recalls263 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938174Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING2 recalls238 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
- EXACTAMIX H938724EBaxter Healthcare Corporation · Set, i.V. Fluid transfer105 reports
- EXACTAMIX H938792Baxter Healthcare Corporation · Set, i.V. Fluid transfer12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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