CLASS II Device recall · Reported 24 Jul 2013 · FDA Enforcement Report
ExactaMix 1200 and 2400 Compounders recalled by Baxa
Baxa is recalling ExactaMix 1200 and 2400 Compounders, distributed nationwide in the US. The recall was initiated on 4 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1752-2013
- FDA event ID
- 65215
- Recalling firm
- Baxa, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2013
- FDA classified
- 18 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 4 Jun 2013 | Recall initiated by company | |
| 18 Jul 2013 | Classified by FDA | +44 days |
| 24 Jul 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Where it was distributed
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Questions about this recall
Is ExactaMix 1200 and 2400 Compounders recalled?
Yes. Baxa recalled ExactaMix 1200 and 2400 Compounders on 4 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1752-2013.
Why was it 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.
Which lots are affected?
ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Where was it sold?
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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