EXACTAMIX H938738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,180 adverse event reports that list this exact device (DI 00085412477220), received between Jan 3, 2018 and Sep 22, 2026 — classified as 1,180 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (681 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 1,180 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that three (3) EXACTAMIX Empty EVA Bag 500 mL leaked at the membrane port. The issue was identified during the compounding process, prior to patient use. The bags contained ISS solution, Parenteral Nutrition solution, and narcotic solution. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856410 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 500 mL EVA TPN Bag leaked from the injection port. The issue was identified during setup. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766796 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that ten (10) ExactaMix 500 mL EVA TPN Bags leaked liquid from the membrane port. This occurred during the compounding process, prior to patient use. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758081 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675409 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  It was reported that two (2) EXACTAMIX Empty EVA Bags 500mL leaked at the administration port. The issue was identified prior to device filling and before patient use. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675260 ↗
• MalfunctionSep 4, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50621088 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230604 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA TPN BAG LEAKED FROM THE MEMBRANE PORT TUBE. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. 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 25565765 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA TPN BAG LEAKED FROM ONE OF THE PORTS. THE ISSUE OCCURRED DURING THE ADJUSTMENT OF NUTRITION IN THE MIXING CENTER, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409949 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA TPN BAG LEAKED AT THE SIDE OF THE BAG. 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 25084045 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) EXACTAMIX 500 ML EVA TPN BAGS LEAKED AT THE MIDDLE PORT INSIDE OF A SECONDARY BAG. THE EVENT OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948161 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA TPN BAG LEAKED FROM ONE OF THE PORTS. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944774 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 500ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING FROM THE MIDDLE PORT. 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 24783785 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT EXACTAMIX 500 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION. 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 24759260 ↗
• MalfunctionMar 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIRTEEN (13) EXACTAMIX 500 ML EVA TPN BAGS HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. 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 24670931 ↗
• MalfunctionMar 23, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIRTY-FIVE (35) EXACTAMIX 500 ML EVA TPN BAGS HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. 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 24670726 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EXACTAMIX 500 ML EVA TPN BAGS LEAKED FROM THE MIDDLE PORT. THIS WAS OBSERVED DURING THE LABELLING PROCESS, PRIOR TO RELEASE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639238 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE MIDDLE PORT. THIS WAS OBSERVED DURING SET UP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445830 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWELVE (12) EXACTAMIX 500 ML EVA TPN BAGS LEAKED AT THE SPIKE PORT. THE ISSUE OCCURRED DURING SETUP IN THE PHARMACY, IV CLEAN ROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334824 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION. THE ISSUE WAS DESCRIBED AS, WHILE PREPARING TO CONNECT THE TPN FORMULA TO THE WATER PORT, IT WAS FOUND THAT FLUID WAS LEAKING FROM THE BAG. THE BAG WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322412 ↗
• MalfunctionFeb 5, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG HAD FOREIGN MATTER IN THE PORT. 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 24265855 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIFTEEN (15) EXACTAMIX 500 ML EVA TPN BAGS HAD FOREIGN MATTER AT UNSPECIFIED LOCATION. 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 24099541 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EXACTAMIX 500 ML EVA TPN BAG HAD FOREIGN MATTER AT UNSPECIFIED LOCATION. 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 24098294 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SEVEN (7) EXACTAMIX 500 ML EVA TPN BAGS HAD FOREIGN MATTER AT UNSPECIFIED LOCATION. 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 24097336 ↗
• MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY THREE (23) EXACTAMIX 500 ML EVA TPN BAGS HAD FOREIGN MATTER AT UNSPECIFIED LOCATION. 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 24096833 ↗

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-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-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-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-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-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-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-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-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-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-2139-2010 · May 26, 2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
• Z-2137-2010 · May 26, 2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.

…and 21 more.