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CONVERTORS 39045NARecalls & reported problems

Cardinal Health 200, LLC · AAMI 4 Breathable Rag BNS XL · Class 2

All models of CONVERTORS (38)

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 50885380134423), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Exposure to Body Fluids1

Recent adverse event reports

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

  • MalfunctionDec 12, 2019Adverse Event Without Identified Device or Use Problem

    NURSE REPORTED BLOOD EXPOSURE WITH A CARDINAL HEALTH GOWN FROM ONE OF THEIR CUSTOM PACKS IN THE OBSTETRICS (OB) DEPARTMENT. THE EXPOSURE REPORTEDLY OCCURRED DURING A CESAREAN BIRTH PROCEDURE LASTING APPROXIMATELY ONE HOUR, BUT WITHOUT DELAY IN THE PROCEDURE. THE (B)(6) FEMALE NURSE HAD LAB WORK COMPLETED FOLLOWING THE EXPOSURE.

    Patient problems: Exposure to Body Fluids

    MAUDE report 9461577 ↗

Other GOWN, SURGICAL devices

All GOWN, SURGICAL devices →

Sources and updates

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