EXACTAMIX H938735Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412477206), received between May 2, 2025 and May 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

37 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING EVALUATION OF A 1000ML CALIBRATION BAG, A WHITE PARTICULATE WAS FOUND INSIDE THE BAG. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954998 ↗

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-0167-2020 · Sep 18, 2019 · Terminated
  EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000
• 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-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-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-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-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-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-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-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-2137-2010 · May 26, 2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.

…and 22 more.