EXACTAMIX H938751Recalls & reported problems
Baxter Healthcare Corporation · EXACTAMIX Inlet, Vented, Micro-Volume Inlet · Class 2
Quick summary
This Baxter ExactaMix vented micro-volume inlet is an IV fluid transfer set. Reports mostly describe foreign matter, leaks, and detached or disconnected components found during pharmacy compounding setup, with no patient involvement. There are 40 reports, no deaths, and no injuries. No recalls name this device.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00085412477299), received between Jan 3, 2018 and Jul 28, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (18 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material18
- Fluid/Blood Leak8
- Contamination5
- Detachment of Device or Device Component5
- Unsealed Device Packaging4
- Disconnection3
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Patient Involvement4
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058690 ↗MalfunctionMar 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX VENTED, MICRO-VOLUME INLET LEAKED WHERE TUBE MEETS THE CONNECTOR (PUSH-ON/LUER LOCK). THIS WAS OBSERVED DURING DELIVERY USING A COMPOUNDER IN THE PHARMACY. THE INLET WAS CONNECTED TO MAGNESIUM ON PORT # 20. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524806 ↗MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR (4) MICRO-VOLUME INLETS HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. THE ISSUE WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24103682 ↗MalfunctionNov 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FIVE (5) MICRO-VOLUME INLETS HAD FOREIGN MATTER AT AN UNSPECIFIED LOCATION. 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 23639293 ↗MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX VENTED MICRO-VOLUME INLET LEAKED WATER DURING USE IN THE PHARMACY. THE INLET WAS CONNECTED TO A VALVE SET ON THE COMPOUNDER AND CONNECTED TO A NON-BAXTER BAG (250ML) FILLED WITH POTASSIUM CHLORIDE (2MEQ/ML). THE INLET WAS REPLACED TO RESOLVE THE EVENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22967278 ↗MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXACTAMIX VENTED, MICRO-VOLUME INLET HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. THE FOREIGN MATTER WAS DISCOVERED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835597 ↗MalfunctionJun 12, 2025Contamination; Contamination
IT WAS REPORTED THAT NINE (9) VENTED, MICRO-VOLUME INLETS HAD BLACK SPOTS IN THE BAGS. THIS ISSUE WAS DETECTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22196357 ↗MalfunctionFeb 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS OBSERVED AT AN UNSPECIFIED LOCATION OF AN EXACTAMIX VENTED MICRO-VOLUME INLET. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322433 ↗MalfunctionFeb 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
I WAS REPORTED THAT AN EXACTAMIX VENTED MICRO-VOLUME INLET HAD PARTICULATE MATTER (PM). THE PM WAS FURTHER DESCRIBED AS ¿LARGE BROWN PARTICLES¿. THIS WAS NOTICED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303976 ↗MalfunctionDec 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A MICRO-VOLUME INLET HAD AN IMBEDDED PARTICLE IN THE SPIKE. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026737 ↗MalfunctionDec 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXACTAMIX VENTED, MICRO-VOLUME INLET HAD FOREIGN MATTER CONTAMINATION. THE CONTAMINATION WAS DESCRIBED AS ¿BLACK MATTER IN THE INLET¿. THIS WAS NOTICED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858182 ↗MalfunctionNov 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXACTAMIX VENTED MICRO-VOLUME INLET HAD FOREIGN PARTICULATE MATTER. SMALL BLACK PARTICLES WERE FOUND ON THE WHITE CONNECTOR AND IN THE PACKAGING OF THE DEVICE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20775832 ↗MalfunctionNov 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SIX (6) EXACTAMIX VENTED MICRO-VOLUME INLETS HAD FOREIGN PARTICULATE MATTER. SMALL BLACK PARTICLES WERE FOUND ON THE WHITE CONNECTOR AND IN THE PACKAGING OF THE DEVICE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773562 ↗MalfunctionOct 15, 2024Contamination; Contamination
IT WAS REPORTED THAT FOUR (4) VENTED MICRO-VOLUME INLETS HAD SMALL MOISTURE DROPLETS BETWEEN SPIKE AND THE CAP. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454761 ↗MalfunctionOct 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR (4) EXACTAMIX VENTED MICRO-VOLUME INLETS HAD BLACK PARTICLES INSIDE THE PACKAGING. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20446780 ↗MalfunctionOct 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER CONTAMINATION WAS OBSERVED IN SEVEN (7) EXACTAMIX VENTED, MICRO-VOLUME INLETS. TWO INLETS HAD CONTAMINATION THAT WAS DESCRIBED AS, ¿SPOT ON WHITE CONNECTOR AND WHITE PART¿, TWO INLETS HAD CONTAMINATION THAT WAS DESCRIBED AS, ¿SPOT ON WHITE CONNECTOR¿, AND THREE INLETS HAD CONTAMINATED THAT WAS DESCRIBED AS, ¿SPOT ON WHITE CONNECTOR, WHITE PART AND INSIDE CAP¿. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20429779 ↗MalfunctionOct 8, 2024Contamination; Contamination
IT WAS REPORTED THAT SOME DROPS OF LIQUID WAS NOTICED ON THE SPIKE OF TWENTY-FIVE (25) VENTED MICRO-VOLUME INLETS. THIS WAS OBSERVED IN UNOPENED PACKAGING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398358 ↗MalfunctionOct 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED UNKNOWN PARTICULATE MATTER WAS OBSERVED IN AN UNSPECIFIED QUANTITY OF MICRO-VOLUME INLETS. THE PARTICULATE MATTER WAS NOTED IN AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343997 ↗MalfunctionSep 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THIRTEEN (13) MICRO-VOLUME INLETS HAD PARTICULATE MATTER (PM). THE PM WAS FURTHER DESCRIBED AS A DARK/BROWN/BLACK SPOTS OR FIBER; THE LOCATION OF THE PM WAS ON THE WHITE CONNECTORS, SPIKE, OR POUCHES. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136096 ↗MalfunctionSep 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR (4) MICRO-VOLUME INLETS HAD FOREIGN PARTICULATE MATTER. ONE (1) UNIT HAD A FIBER IN THE POUCH, AND THREE (3) UNITS HAD A DARK SPOT ON THE WHITE CONNECTOR. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136001 ↗MalfunctionAug 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED UNSPECIFIED PARTICULATE MATTER (PM) WAS OBSERVED IN FIVE (5) MICRO-VOLUME INLETS. THE LOCATION OF THE PM WAS NOT REPORTED. THIS WAS NOTICED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19980228 ↗MalfunctionMay 9, 2024Contamination; Contamination
IT WAS REPORTED THAT A MICRO-VOLUME INLET (WITH LARGE BORE SPIKE) HAD LIQUID CONTAMINATION IN THE INLET LEAD. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282281 ↗MalfunctionMay 9, 2024Contamination; Contamination
IT WAS REPORTED THAT A MICRO-VOLUME INLET (WITH LARGE BORE SPIKE) HAD LIQUID CONTAMINATION IN THE INLET LEAD. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282228 ↗MalfunctionFeb 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING DETACHED FROM THE HARD PLASTIC SPIKE OF A MICRO-VOLUME INLET. THIS WAS FOUND IN THE CABINET OF THE CLEANROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16418106 ↗MalfunctionJan 23, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE TUBING AND SPIKE OF A MICRO-VOLUME INLET (W/LARGE BORE SPIKE) WHICH RESULTED IN A LEAK. THE ISSUE WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16230158 ↗
Other Set, i.V. Fluid transfer devices
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- 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 H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.