Exacta-Mix 2400 pharmacy compounding system recallZ-0210-04 · Baxa Corporation · initiated Nov 7, 2003
Terminated All recalls posted in July 2004
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
If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..
FDA root cause category: Other
What the company is doing
All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
Recall details
- Recall number
- Z-0210-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 7, 2003
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Baxa Corporation
- Quantity
- 231 systems
- Product code
- NEP
- FDA submissions
- K002705
- Distribution
- Nationwide. Foreign distribution to UK. No government or military consignees.
Product description
Exacta-Mix 2400 pharmacy compounding system.
Code information (models, lots, serial numbers)
Catalog Number EM2400, all serial numbers.
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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