EXACTAMIX H938739Recalls & reported problems

Summary

The FDA's MAUDE database contains 972 adverse event reports that list this exact device (DI 00085412477237), received between Jan 19, 2018 and Sep 17, 2026 — classified as 972 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (648 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 18, 2019Terminated

   Potential ability to leak once used for compounding.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 972 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  It was reported that four (4) ExactaMix 1000 mL EVA TPN Bags leaked from the administration port. This occurred during setup and preparation. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797528 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 1000 ml EVA TPN Bag leaked from the administration port. This occurred during an unspecified process step. 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 50766628 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408973 ↗
• MalfunctionAug 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255634 ↗
• MalfunctionAug 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246513 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241126 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230593 ↗
• MalfunctionAug 7, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173741 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073678 ↗
• MalfunctionJul 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058831 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046303 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) EXACTAMIX 1000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED FROM ONE OF ITS PORTS. THIS WAS OBSERVED DURING THE ADJUSTMENT OF NUTRITION IN THE MIXING CENTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407426 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 1000 ML EXACTAMIX EMPTY EVA BAGS LEAKED AT THE ADMINISTRATION PORT. THE EVENT OCCURRED DURING NUTRITION PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223499 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EXACTAMIX 1000 ML EVA TPN BAGS LEAKED AT THE JUNCTION OF THE SEAL AND THE CONNECTION (ADMINISTRATION PORT). THE ISSUE WAS NOTICED DURING THE PREPARATION OF THE NUTRITION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211504 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA TPN BAG LEAKED AROUND THE INJECTION PORT. THIS OCCURRED DURING PATIENT USE. THE BAG WAS REPLACED TO RESOLVE THE ISSUE. 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 25186801 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165286 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) EXACTAMIX 1000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE MEMBRANE 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 25165158 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA TPN BAG LEAKED FROM ONE OF THE PORTS. THIS WAS OBSERVED DURING THE ADJUSTMENT OF NUTRITION IN THE MIXING CENTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143726 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA TPN BAG LEAKED AT THE SIDE OF THE BAG. 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 25114231 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE(3) EXACTAMIX 1000 ML EVA TPN BAGS LEAKED FROM AN UNSPECIFIED LOCATION. THE ISSUE WAS NOTICED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947920 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EXACTAMIX 1000 ML EVA TPN BAGS 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 24946495 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX EVA BAG 1000ML BAG LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918201 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE MEMBRANE 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 24916640 ↗
• MalfunctionApr 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT EIGHT (8) EXACTAMIX 1000ML EVA BAG LEAKED. 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 24889450 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1000 ML EVA TPN BAG LEAKED PARENTERAL NUTRITION AT THE INSERTION (ADMINISTRATION) PORT. THIS WAS OBSERVED DURING USE AT THE MIXING CENTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840727 ↗

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-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-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-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-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-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-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-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-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-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-2144-2010 · May 26, 2010 · Terminated
  Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
• 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.