Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF:… recallZ-1197-2010 · Baxa Corporation · initiated Feb 10, 2010
Terminated All recalls posted in March 2010
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
Molding defect in the valve body causes leaking.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.
Recall details
- Recall number
- Z-1197-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 10, 2010
- Posted by the FDA
- Mar 23, 2010
- Recalling firm
- Baxa Corporation
- Quantity
- 3230 cases; 32300 units (10 units/case)
- Product code
- LHI
- FDA submissions
- K002705
- Distribution
- Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.
Product description
Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
Code information (models, lots, serial numbers)
Model number: 724, Lot Numbers: 740789 through 742707 (sequentially numbered).
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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