EXACTAMIX H938724Recalls & reported problems
Baxter Healthcare Corporation · EXACTAMIX 2400 Valve Set, 24-Port Valve Assembly · Class 2
All models of EXACTAMIX (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Baxter Exactamix valve set has 513 adverse event reports, with no deaths and no injuries. Most reports describe fluid leaks, air bubbles in the line and connectors coming loose during setup and use. One open recall from July 2022 concerns possible leaking valves in certain lots. Reports rose to 138 in the last 12 months from 31 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 513
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 513 adverse event reports that list this exact device (DI 00085412477183), received between Mar 23, 2018 and Sep 16, 2026 — classified as 513 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (307 reports).
1 FDA recall record name this device's identifier, 1 still open.
14 other recalls cover devices cleared under the same FDA submission (K002705); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Jul 14, 2022Open, Classified
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Z-1570-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak307
- Air/Gas in Device147
- Free or Unrestricted Flow49
- Device Contamination with Chemical or Other Material36
- Disconnection21
- Contamination6
- Loose or Intermittent Connection5
- Protective Measures Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions478
- No Patient Involvement33
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 513 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794593 ↗MalfunctionAug 31, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520830 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463050 ↗MalfunctionMay 8, 2026Air/Gas in Device
IT WAS REPORTED THAT THERE WAS AIR LEAKAGE INTO AN EXACTAMIX 2400 VALVE SET. EXCESSIVE AIR BUBBLE LEAKAGE WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127640 ↗MalfunctionMay 7, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LARGE BORE MALE CONNECTOR (END PORTS) OF TWO (02) EM2400 VALVE SETS POPS OUT, RESULTED IN LEAK. THIS OCCURRED DURING PUMPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113885 ↗MalfunctionMay 5, 2026Air/Gas in Device
IT WAS REPORTED THAT AN EXACTAMIX 2400 VALVE SET HAD AIR BUBBLES ENTERING PORT 5 RESULTING IN INSUFFICIENT CONCENTRATION OF NUTRIENTS POTASSIUM AND PHOSPHORUS BEING DELIVERED TO THE PATIENT. THE AIR BUBBLES WERE IDENTIFIED DURING PREPARATION; HOWEVER, THE INFUSION BAG WAS THEN USED ON A PATIENT BEFORE PHARMACIST CHECKED THE CONCENTRATION OF NUTRIENTS IN THE BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082774 ↗MalfunctionApr 23, 2026Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS LEAKED FROM PORT 5, RESULTING IN AIR BUBBLES IN THE LINE. THIS WAS OBSERVED DURING INGREDIENT DELIVERY USING THE COMPOUNDER IN THE PHARMACY. VENTED INLETS WERE CONNECTED TO THE VALVE SETS ON PORT 5 TO PUMP POTASSIUM PHOSPHATE (KPHOS). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24969827 ↗MalfunctionApr 20, 2026Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF EXACTAMIX 2400 VALVE SETS HAD A LEAKY PORT #5 THAT CAUSES AIR IN LINE AND BUBBLES. THIS OCCURRED DURING COMPOUNDING IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933126 ↗MalfunctionApr 20, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THREE (3) EXACTAMIX 2400 VALVE SETS HAD AN OILY SUBSTANCE ON THE HARD PLASTIC CASING. THIS EVENT OCCURRED WHILE PHARMACY STAFF WERE PREPARING THE EXACTAMIX FOR COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933080 ↗MalfunctionApr 14, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE MAIN LINE OF AN EXACTAMIX 2400 VALVE SET. THE REPORTER STATED THAT ¿THE VALVE SET DOES NOT SEEM TO BE FULLY SECURE.¿ THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879150 ↗MalfunctionApr 14, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE MAIN LINE OF AN EXACTAMIX 2400 VALVE SET. THE REPORTER STATED THAT ¿THE VALVE SET DOES NOT SEEM TO BE FULLY SECURE.¿ THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879075 ↗MalfunctionApr 13, 2026Precipitate in Device or Device Ingredient
IT WAS REPORTED THAT PRECIPITATION WAS OBSERVED WHEN USING AN EM2400 VALVE SET. THE SOLUTION DELIVERED TO AN UNSPECIFIED BAG APPEARED CLOUDY. POTASSIUM PHOSPHATE WAS ADMINISTERED THROUGH PORT 5, AND CALCIUM GLUCONATE THROUGH PORT 21. A FLUSH WAS PERFORMED TO CLEAR THE EXISTING LINE OF ANY ADDITIVES, FOLLOWED BY RUNNING A PRIMING BATCH HOWEVER, PRECIPITATION WAS OBSERVED IN THE BAG. THIS ISSUE WAS IDENTIFIED AFTER COMPLETION OF THE PRIME AND VERIFY STAGE OF THE SETUP. IT WAS SUSPECTED THAT THE VALVE SETS WERE DEFECTIVE AND ALLOWED LEAKAGE BETWEEN TWO COMPONENTS (CALCIUM AND POTASSIUM PHOSPHATE), RESULTING IN PRECIPITATION. THERE WAS NO PATIENT INVOLVEMENT. THE VALVE SETS WERE REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861363 ↗MalfunctionApr 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A EXACTAMIX 2400 VALVE SET WAS "LEAKING ON PORT 3 HAS MELTED AREA". THE EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832504 ↗MalfunctionApr 8, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EM2400 VALVE SET HAD LEAKY PORT #5 WHICH RESULTED IN AIR AND BUBBLES IN THE LINE. THIS OCCURRED DURING SETUP/PREPARATION AT THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818973 ↗MalfunctionApr 8, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR LEAKAGE WAS OBSERVED FROM PORT 5 DURING USE OF AN EXACTAMIX 2400 VALVE SET. THE EVENT OCCURRED DURING MEDICINE PUMPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818198 ↗MalfunctionApr 8, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR LEAKAGE WAS OBSERVED FROM PORT 5 DURING USE OF AN EXACTAMIX 2400 VALVE SET. THE EVENT OCCURRED DURING MEDICINE PUMPING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818197 ↗MalfunctionMar 24, 2026Air/Gas in Device
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EM2400 VALVE SETS WERE ACCUMULATING BUBBLES WHEN PORT 5 WAS ACTIVATED DURING SETUP WHILE BEING USED WITH THE COMPOUNDER. IT WAS FURTHER INFORMED THAT THERE MAY HAVE BEEN LEAK, OR AIR ENTERING VIA VALVE SET. THE INGREDIENTS WERE MOVED FROM PORT 5 TO PORT 10 TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682488 ↗MalfunctionMar 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A EM2400 VALVE SET LEAKED FROM THE TUBING ASSEMBLY. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621327 ↗MalfunctionMar 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A EM2400 VALVE SET LEAKED. THE ISSUE WAS OBSERVED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489771 ↗MalfunctionFeb 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EM2400 VALVE SET HAD A LEAKY PORT 5 THAT CAUSES AIR IN LINE AND BUBBLES. THIS OCCURRED DURING COMPOUNDING POTASSIUM PHOSPHATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468129 ↗MalfunctionFeb 23, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EM2400 VALVE SET WAS FOUND TO BE "GREASY". THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24417548 ↗MalfunctionFeb 17, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EM2400 VALVE SET FELT SLIPPERY WHEN HANDLING IT. THE ISSUE WAS NOTICED WHILE OPENING THE VALVE SET PACKAGE INSIDE IV HOOD DURING PREPARATION. THE PACKAGING CONTAINED AN OILY, SEEMINGLY SCENT-FREE LIQUID. MORE MOISTURE WAS NOTICED THAN EXPECTED. A NEW VALVE SET WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370678 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EM2400 VALVE SET HAD LEAKY PORT 5 RESULTING IN BUBBLE IN LINE. THIS WAS NOTICED DURING DELIVERY. THE CONFIGURATION WAS UPDATED TO AVOID PORT 5 TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370673 ↗MalfunctionFeb 12, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION ON AN EXACTAMIX 2400 VALVE SET. THE PM WAS DESCRIBED AS AN OILY SUBSTANCE ON THE NEWLY OPENED VALVE SET. THIS ISSUE WAS OBSERVED IN THE PHARMACY PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327208 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWELVE (12) UNITS OF EM2400 VALVE SETS LEAKED FROM THE VALVE STATION 5. THIS OCCURRED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314162 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K002705. One submission often covers many models, so check the product and lot details in each record.
- Z-2262-2026 · Apr 22, 2026 · Open, ClassifiedBrand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the
- Z-3084-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
- Z-3082-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
- Z-3085-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
- Z-3083-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
- Z-1001-2024 · Dec 22, 2023 · Open, ClassifiedBaxter Exactamix Pro 1200, REF EXM12DY
- Z-1002-2024 · Dec 22, 2023 · Open, ClassifiedBaxter Exactamix Pro 2400, REF EXM24DY
- Z-1911-2018 · Apr 25, 2018 · TerminatedBaxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharm
- Z-1908-2018 · Apr 25, 2018 · TerminatedBaxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding
- Z-1910-2018 · Apr 25, 2018 · TerminatedBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used
- Z-1909-2018 · Apr 25, 2018 · TerminatedBaxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used
- Z-1752-2013 · Jun 4, 2013 · TerminatedExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
- Z-1197-2010 · Feb 10, 2010 · TerminatedExacta-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
- Z-0210-04 · Nov 7, 2003 · TerminatedExacta-Mix 2400 pharmacy compounding system.
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
- Alaris, SmartSite 20027EBD Switzerland Sàrl · Set, i.V. Fluid transfer1 death183 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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