EXACTAMIX H938901Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412477466), received between Nov 28, 2018 and Apr 30, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

9 other recalls cover devices cleared under the same FDA submission (K960581); 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT 1 SAMPLE OF COMPOUNDED PRODUCT WAS IDENTIFIED WITH A LEAK BY THE END USER PRIOR TO USE. DETAILS STATE, "WHEN THEY WENT TO CUT OPEN THE BAG, THEY LIFTED THE BAG STILL IN SILVER OVER POUCH AND THEY NOTICED FLUID LEAKING OUT OF THE 2 SMALL AIR HOLES OF THE OVER POUCH. WHEN THEY CUT IT OPEN AND TOOK OUT THE BAG ON THEIR BENCH, THEY NOTICED THE BAG LEAK WAS QUITE SEVERE. WHAT THEY FOUND WAS THE BAR THAT SEPARATES THE 2 SECTIONS, THERE WAS A SPLIT RIGHT NEXT TO THE SEPARATION BAR ON THE SIDE OF THE YELLOW LIQUID". THE CUSTOMER WAS WEARING GLOVES WHILE HANDLING THE SAMPLE AND NO SKIN CONTACT WAS REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE SAMPLE WAS DISCARDED BY THE CUSTOMER. IMAGES OF THE SAMPLE WERE PROVIDED BUT NO LEAK LOCATION WAS IDENTIFIED. THE CUSTOMER STATED THAT THE OVERPOUCH AND EXTERNAL PACKAGING CARTON DID NOT APPEAR DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217501 ↗
• MalfunctionMar 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  PHARMACY REPORTED ONE UNIT "HAD A PINHOLE LEAK IN THE LIPID PHASE SECTION OF THE BAG. ERROR WAS DETECTED AFTER COMPOUNDING , BUT BEFORE RELEASE. THE ONLY COMPONENT ADDED TO BAG BY INJECTION WITH NEEDLE WAS 0.68ML INTO THE CLEAR PHASE OF THE BAG." THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572426 ↗
• MalfunctionMar 13, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A 1500 ML DUAL-CHAMBER EVA (ETHYL VINYL ACETATE) BAG HAD A PINHOLE LEAK IN THE LIPID PHASE SECTION OF THE BAG. THIS WAS IDENTIFIED AFTER COMPOUNDING, BUT BEFORE RELEASE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534737 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVISED ONE UNIT OF A COMPOUNDED BAG WAS FOUND TO BE LEAKING AT A PATIENT'S HOME PRIOR TO USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION NOR WAS THERE ANY REPORT OF SKIN CONTACT WITH SPILLED PARENTERAL NUTRITION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571204 ↗
• MalfunctionAug 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A HOME PARENTERAL NUTRITION PATIENT'S FATHER REPORTED THAT ONE UNIT OF A COMPOUNDED PARENTERAL NUTRITION (PN) BAG WAS FOUND TO BE LEAKING ON DELIVERY. THE LEAK WAS IDENTIFIED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT THE SHIPPING CARTON WAS WET AND THAT SKIN CONTACT OCCURRED WITH THE PARENTERAL NUTRITION SOLUTION. THE CUSTOMER STATED "SOMEONE PICKED UP CARTON AND BROUGHT INSIDE HOME, AND FOUND LIQUID INSIDE THE CARTON. HAND WAS WASHED WITH SOAP. LEAKING BAG WAS DISCARDED AFTER TAKING PHOTOS". THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199822 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE UNIT OF A TOTAL PARENTERAL NUTRITION (TPN) BAG WAS FOUND TO BE LEAKING WHEN TAKEN OUT OF THE FREEZER. THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111818 ↗
• MalfunctionNov 12, 2020Break; Break

  IT WAS REPORTED THAT SEVEN (7) EXACTAMIX 1500 ML DUAL-CHAMBER EVA BAGS HAD ISSUES OF FAILED OR BAD CLAMPS. IT WAS FURTHER REPORTED THAT SHARDS OF PLASTIC WERE BREAKING OFF WHEN CLOSING THE CLAMPS. THIS WAS IDENTIFIED DURING PREPARATION OF THE BAGS, DURING THE PROCESS OF CLAMPING THE TUBING AFTER THE BAGS WERE MIXED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10831634 ↗
• MalfunctionSep 18, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CLAMPS OF AN UNSPECIFIED QUANTITY, AT LEAST, EIGHT (8) EXACTAMIX® 1500 ML DUAL-CHAMBER EVA BAGS WERE DIFFICULT TO CLOSE; FURTHER DESCRIBED AS THE CUSTOMER ¿HAD TO USE SIGNIFICANT FORCE TO CLOSE THE CLIPS OR THEY COULD NOT CLOSE THEM AT ALL AND HAD TO REPLACE THEM ENTIRELY¿. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10557002 ↗
• MalfunctionNov 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 1500 ML DUAL-CHAMBER EVA BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION PRIOR TO USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960581. One submission often covers many models, so check the product and lot details in each record.

• Z-0002-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0007-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-0008-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-0006-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0005-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0001-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0004-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0003-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-2263-2016 · Jun 23, 2016 · Terminated
  Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL