EXACTAMIX H938737Recalls & reported problems

Baxter Healthcare Corporation · EXACTAMIX Empty EVA Bag · Class 2

Quick summary

This Baxter ExactaMix is an empty plastic bag used to transfer intravenous fluids. Of the 603 reports naming it, most describe fluid leaking from the bag, and some describe contamination with chemicals or other material. The reports describe no patient involvement, no injuries and no deaths. One recall, now closed, started in September 2019 and concerned a possible leak after the bag is used for compounding.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 607
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 607 adverse event reports that list this exact device (DI 00085412477213), received between Dec 29, 2017 and Sep 23, 2026 — classified as 607 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (428 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Sep 18, 2019Terminated
Potential ability to leak once used for compounding.
Z-0167-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak428
Device Contamination with Chemical or Other Material156
Break10
Disconnection5
Difficult to Open or Close4
Material Perforation4
Material Puncture/Hole4
Detachment of Device or Device Component2

Patient problems

No Clinical Signs, Symptoms or Conditions283
No Patient Involvement282
No Consequences Or Impact To Patient40
No Known Impact Or Consequence To Patient2
Premature Labor1

Recent adverse event reports

The 25 most recent of 607 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875490 ↗
MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781560 ↗
MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725181 ↗
MalfunctionSep 8, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675855 ↗
MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675262 ↗
MalfunctionSep 5, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50624713 ↗
MalfunctionSep 5, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50624695 ↗
MalfunctionSep 4, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50613147 ↗
MalfunctionSep 1, 2026Fluid/Blood Leak
It was reported that an ExactaMix 250 mL EVA TPN Bag leaked at the membrane port. The issue was identified before use. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535894 ↗
MalfunctionAug 25, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433649 ↗
MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230617 ↗
MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) 250ML EXACTAMIX EMPTY EVA (ETHYLENE VINYL ACETATE) BAGS LEAKED AT THE MEMBRANE PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25289545 ↗
MalfunctionMay 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT SEVEN (07) EXACTAMIX 250 ML EVA TPN BAGS LEAKED FROM AN UNSPECIFIED LOCATION. 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 25096608 ↗
MalfunctionMay 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX 250 ML EVA TPN BAG LEAKED FROM AN UNSPECIFIED LOCATION. 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 25096607 ↗
MalfunctionMar 30, 2026Fluid/Blood Leak
IT WAS REPORTED THAT FOUR (4) 250ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING AT THE ADMINISTRATION PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717376 ↗
MalfunctionMar 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) 250ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING FROM THE ADMINISTRATION PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691812 ↗
MalfunctionMar 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX® 250 ML EVA TPN BAG LEAKED AT THE MEMBRANE 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 24553515 ↗
MalfunctionFeb 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) EXACTAMIX 250 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE SPIKE PORT. THIS WAS OBSERVED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434204 ↗
MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) 250ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAGS WERE LEAKING FROM THE MEMBRANE PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368697 ↗
MalfunctionFeb 13, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) EXACTAMIX 250 ML EVA TPN BAGS LEAKED AT THE ADMINISTRATION PORT. THE ISSUE OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332133 ↗
MalfunctionFeb 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A 250ML EXACTAMIX EVA (ETHYLENE VINYL ACETATE) BAG WAS LEAKING FROM THE ADMINISTRATION PORT AREA. THE LEAK WAS IDENTIFIED DURING MIXING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318003 ↗
MalfunctionJan 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A 250ML EXACTAMIX EVA BAG WAS LEAKING FROM THE ADMINISTRATION 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 24195908 ↗
MalfunctionJan 13, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX 250 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE ADMIN 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 24058865 ↗
MalfunctionJan 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN EXACTAMIX 250 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP. 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 24030447 ↗
MalfunctionJan 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) 250ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED THROUGH THE MIDDLE 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 23943099 ↗

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-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-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-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-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-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-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-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-2146-2010 · May 26, 2010 · Terminated
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, 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.

Device details

UDI-DI	`00085412477213`
Brand	EXACTAMIX
Model	H938737
Company	Baxter Healthcare Corporation
Product code	LHI · Set, i.V. Fluid transfer
Class	Class 2
FDA submission	K900585
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 27, 2022

Device type (GMDN): Intravenous administration bag/bottle

An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

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EXACTAMIX H938724
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.