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EXACTAMIX H938711008Recalls & reported problems

Baxter International Inc. · EXACTAMIX Cap - Large Bore, Internal Thread · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412480060), received between May 18, 2018 and May 18, 2018 — classified as 1 malfunction.

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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionMay 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT A BLACK STAIN WAS OBSERVED ON THE PRIMARY PACKAGING OF AN EXACTAMIX LARGE BORE CAP. THE CONTAMINATION WAS DISCOVERED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 7525363 ↗

Other DISPENSER, LIQUID MEDICATION devices

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Sources and updates

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