EXACTAMIX H938741Recalls & reported problems

Summary

The FDA's MAUDE database contains 710 adverse event reports that list this exact device (DI 00085412477251), received between Jan 16, 2018 and Sep 15, 2026 — classified as 1 injury, 709 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (664 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 710 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782150 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50660454 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 3000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. 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 25641577 ↗
• MalfunctionJun 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA TPN BAG LEAKED AT THE SHOULDER WELD. 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 25548760 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG HAD A DAMP SPOT. THE TPN WAS REMOVED FROM AMBER BAG AND A PINHOLE LEAK WAS OBSERVED AT THE TOP SIDE EDGE OF THE BAG. THIS WAS OBSERVED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147316 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 3000 ML EVA TPN BAGS LEAKED FROM "THE ADMINISTRATION INFUSION ENTRY PORT". THE ISSUES WERE IDENTIFIED AFTER THE DEVICES WERE COMPOUNDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680346 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 3000 ML EVA TPN BAGS LEAKED FROM "THE ADMINISTRATION INFUSION ENTRY PORT". THE LEAKS WERE IDENTIFIED AFTER THE DEVICES WERE COMPOUNDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674154 ↗
• MalfunctionMar 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA TPN BAG LEAKED "AT THE FOIL WRAPPED PORT AND THE BAG SEAL AROUND THAT". THE ISSUE WAS NOTICED DURING SET UP OF THE DEVICE FOR CONNECTION PRIOR TO PATIENT USE WHEN A PUDDLE WAS OBSERVED UNDER THE BAG. UPON OPENING THE SILVER OVERWRAP, THE BAG WAS FOUND FULL OF LIQUID. A SPARE BAG WAS AVAILABLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540567 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000ML EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE ADMINISTRATION PORT. THE LEAK WAS OBSERVED AFTER PREPARATION WAS MADE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526904 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA TPN BAG LEAKED FROM THE ADMINISTRATION PORT. THE ISSUE WAS NOTICED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526538 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) 3000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WERE LEAKING FROM THE SEAL NEAR THE MIDDLE PORT. THE LEAKS WERE OBSERVED DURING THE FINAL CHECKING PROCESS IN THE PHARMACY DEPARTMENT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326990 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 3000ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE SIDE OF THE BAG. THE LEAK WAS OBSERVED WHILE COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241730 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 3000ML EXACTAMIX EVA BAG WAS LEAKING FROM 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 24046179 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE "ERGONOMIC PORT". THIS OCCURRED DURING COMPOUNDING. 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 22892862 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, "LEAKAGE WAS OBSERVED FROM THE ERGONOMIC SPOUT OF THE BAG". 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 22849870 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED AT THE ADMINISTRATION PORT. THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367277 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 3000 ML EVA TPN BAGS LEAKED AT THE YELLOWISH PORT (WHERE THE BAG WOULD BE SPIKED). THE ISSUE OCCURRED AFTER COMPOUNDING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172003 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE ORANGE/TAN COLORED PORT (MEMBRANE PORT). THE BAG CONTAINED COMPOUNDED TOTAL PARENTERAL NUTRITION (TPN) OF VOLUME 2879.4ML. THIS OCCURRED IMMEDIATELY AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171986 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE ADMINISTRATION PORT. THIS OCCURRED AFTER COMPOUNDING. 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 22171148 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064336 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (1 BOX) OF EXACTAMIX 3000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE INJECTION PORT. THE LEAK WAS AT THE JUNCTION OF THE CLEAR NECK AND WHITE CAP OF THE INJECTION PORT. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884147 ↗
• MalfunctionMar 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (02) EXACTAMIX 3000 ML EVA TPN BAGS HAD PARTICULATE MATTER INSIDE THE PRIMARY CONTAINER (BAG). THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638577 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED THROUGH THE ADMINISTRATION 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 21393445 ↗
• MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 3000 ML EVA TPN BAG LEAKED FROM THE MEMBRANE PORT. THIS WAS DETECTED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286742 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 3000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED FROM A PINHOLE AT THE TOP LEFT SEAM OF THE BAG. THESE WERE OBSERVED 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 21120419 ↗

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-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-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-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-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-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-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-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-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-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-2143-2010 · May 26, 2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
• 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.

…and 21 more.