EXACTAMIX H938792Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00085412477305), received between Jul 26, 2019 and Nov 21, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

15 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (MORE THAN 10) OF EXACTAMIX EM1200 VALVE SETS HAD THE TUBING DETACHED AT THE LUER CONNECTOR RESULTING IN LEAKS. THIS OCCURRED DURING FILLING OF TOTAL PARENTERAL NUTRITION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751541 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 1200 VALVE SETS WERE LEAKING LIPIDS FROM PORT 1 INTO THE FINAL BAG. THIS OCCURRED DURING DELIVERY IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623100 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 1200 VALVE SETS WERE LEAKING LIPIDS FROM PORT 1 INTO THE FINAL BAG. THIS OCCURRED DURING DELIVERY IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622987 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 1200 VALVE SETS WERE LEAKING LIPIDS FROM PORT 1 INTO THE FINAL BAG. THIS OCCURRED DURING DELIVERY IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622412 ↗
• MalfunctionOct 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PARTICULATE WAS OBSERVED ON TWELVE (12) EXACTAMIX EM1200 VALVE SETS. THERE WAS LOOSE WHITE PM (PARTICULATE MATTER) COVERING THE PORT CAPS. 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 20417438 ↗
• MalfunctionSep 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) EXACTAMIX EM1200 VALVE SETS HAD WHITE AND DARK PARTICLES. THE PARTICLES WERE LOCATED ON THE TUBING AND VALVE PORT CAPS. 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 20316776 ↗
• MalfunctionSep 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) EXACTAMIX EM1200 VALVE SETS HAD WHITE AND DARK PARTICLES. THE PARTICLES WERE LOCATED ON THE TUBING AND VALVE PORT CAPS. 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 20315758 ↗
• MalfunctionSep 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) EXACTAMIX EM1200 VALVE SETS HAD WHITE AND DARK PARTICLES. THE PARTICLES WERE LOCATED ON THE TUBING AND VALVE PORT CAPS. 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 20313582 ↗
• MalfunctionSep 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LIPIDS "LEAKED BACK INTO" THE UNSPECIFIED QUANTITY OF EXACTAMIX EM1200 VALVE SETS. THESE OCCURRED DURING USE IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267594 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EXACTAMIX EM1200 VALVE SET LEAKED BETWEEN THE TUBING AND CONNECTOR. THE ¿FEMALE¿ END OF THE VALVE ASSEMBLY TRANSFER SET SEPARATED FROM THE TUBING. THIS OCCURRED DURING PRODUCTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174319 ↗
• MalfunctionFeb 19, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX VALVE SET LEAKED. THE PORT THAT CONNECTS TO THE EMPTY BAG, FULLY DISCONNECTED FROM THE TUBING RESULTING IN LEAK OF SOLUTION. THIS OCCURRED UNDER THE HOOD DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731218 ↗
• MalfunctionJul 26, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT FOUR (4) EXACTAMIX 1200 VALVE SETS DISCONNECTED DURING COMPOUNDING, LEADING TO A LEAK. THE REPORTER STATED THAT THE TUBING SET END HAS ¿BLOWN OFF¿ THE FINAL BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8831721 ↗

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, Classified
  Brand 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, Classified
  Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
• Z-3082-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
• Z-3083-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
• Z-3085-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
• Z-1002-2024 · Dec 22, 2023 · Open, Classified
  Baxter Exactamix Pro 2400, REF EXM24DY
• Z-1001-2024 · Dec 22, 2023 · Open, Classified
  Baxter Exactamix Pro 1200, REF EXM12DY
• Z-1570-2022 · Jul 14, 2022 · Open, Classified
  The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one
• Z-1910-2018 · Apr 25, 2018 · Terminated
  Baxter 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 · Terminated
  Baxter 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-1908-2018 · Apr 25, 2018 · Terminated
  Baxter 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-1911-2018 · Apr 25, 2018 · Terminated
  Baxter 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-1752-2013 · Jun 4, 2013 · Terminated
  ExactaMix 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 · Terminated
  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
• Z-0210-04 · Nov 7, 2003 · Terminated
  Exacta-Mix 2400 pharmacy compounding system.