EXACTAMIX H938740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,350 adverse event reports that list this exact device (DI 00085412477244), received between Jan 2, 2018 and Sep 17, 2026 — classified as 1,350 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1,200 reports).

1 FDA recall record name this device's identifier.

36 other recalls cover devices cleared under the same FDA submission (K900585); 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.

Recalls naming this device

1. Sep 18, 2019Terminated

   Potential ability to leak once used for compounding.

   Z-0167-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,350 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809254 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 2000 mL EVA TPN Bag leaked at the injection site. This occurred during preparation, prior to patient use. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754044 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310442 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024182 ↗
• MalfunctionJul 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) EXACTAMIX EMPTY EVA BAGS 2000ML LEAKED AT "THE BOTTOM LEFT SEAM OF THE BAG". THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THE REPORTER STATED THAT "BAGS WERE TAPPED TO CHECK FOR PARTICULATES", PLACED IN A LARGE RESEALABLE PLASTIC BAG, AND STORED UNDER REFRIGERATED CONDITIONS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25832980 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE BAG SEAM. THIS BAG HAD A SEAL DEFECT AROUND THE ADDITIVE PORT CAUSING IT TO LEAK IN THE SEAM. THE LEAKS WERE OBSERVED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641700 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000 ML EXACTAMIX EMPTY EVA BAG LEAKED FROM THE ADMINISTRATION PORT. THE EVENT OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25290021 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED FROM THE INJECTION PORT. THE ISSUE WAS NOTICED AFTER COMPOUNDING THE DEVICE, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130723 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING FROM THE MEMBRANE PORT. THE LEAKS WERE 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 25112886 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE MEMBRANE PORT. THE LEAK WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809179 ↗
• MalfunctionApr 3, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) IN A 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG. THE PM WAS DESCRIBED AS, ¿A WHITE STRIP-SHAPED FOREIGN OBJECT¿. THE PM 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 24775251 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED AT THE PORT WHERE THE "VENOCLYSIS EQUIPMENT IS INSTALLED". THIS WAS OBSERVED DURING PREPARATION, BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769881 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000ML EXACTAMIX EMPTY EVA BAG LEAKED FROM THE MEMBRANE PORT. 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 24743394 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EXACTAMIX 2000 ML EVA TPN BAGS LEAKED AT THE ADMINISTRATION PORT. THE ISSUES WERE NOTICED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738986 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED AT ONE OF THE PORTS. THE ISSUE WAS DETECTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708651 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED FROM ONE OF THE PORTS DUE TO POOR SEALING. THIS WAS OBSERVED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612817 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak; Material Puncture/Hole; Material Split, Cut or Torn

  DURING EVALUATION OF SEVEN (7) RETURNED EXACTAMIX 2000 ML EVA TPN BAGS, LEAKS AND DAMAGE (TORN) BAGS WERE OBSERVED. THREE (3) BAGS HAD LEAKS ORIGINATING FROM ADMINISTRATION PORT, TWO (2) BAGS HAD PIN HOLE LEAKS, AND TWO (2) BAGS WERE FOUND TORN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533769 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF EXACTAMIX 2000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED FROM THE ADMINISTRATION PORT. 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 24457142 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE MEMBRANE PORT. THE LEAK WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421599 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED FROM THE ADMINISTRATION PORT. THE ISSUE WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248245 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 2000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING AT THE INJECTION PORT. THE LEAK 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 24241802 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE PORT. THIS WAS OBSERVED DURING FILLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171421 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 2000ML EXACTAMIX EVA BAG WAS LEAKING FROM THE ADMINISTRATION PORT. THE LEAK WAS OBSERVED DURING COMPOUNDING FILLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166846 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED AT THE PORT CONNECTION TO THE INFUSION DEVICE. THIS WAS OBSERVED DURING FILLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151211 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2000 ML EVA TPN BAG LEAKED FROM ONE OF THE PORTS. THE ISSUE WAS OBSERVED WHILE FILLING DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149888 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900585. One submission often covers many models, so check the product and lot details in each record.

• Z-0364-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administ
• Z-0366-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0365-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0367-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0363-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administra
• Z-0007-2017 · Aug 24, 2016 · Terminated
  0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
• Z-2165-2013 · Aug 22, 2013 · Terminated
  Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer
• Z-1967-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1963-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1965-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1966-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1964-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1962-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be adminis
• Z-2148-2010 · May 26, 2010 · Terminated
  Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporat
• Z-2147-2010 · May 26, 2010 · Terminated
  Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.

…and 21 more.