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EXACTAMIX H9382400-LRecalls & reported problems

Baxter Healthcare Corporation · EXACTAMIX Compounder, Load Cell Module · Class 2

All models of EXACTAMIX (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412482613), received between Aug 25, 2019 and Apr 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Device problems

  • Break1
  • Microbial Contamination of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

    IT WAS REPORTED THAT A LOAD CELL MODULE HAD MICROBIAL GROWTH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11608400 ↗
  • MalfunctionAug 25, 2019Break; Break

    IT WAS REPORTED THAT THE EM 2400, LOAD CELL MODULE HAD FRAYED CORD AND METAL SHOWING INSIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 8928887 ↗

Other SYSTEM/DEVICE, PHARMACY COMPOUNDING devices

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Sources and updates

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