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CONVERTORS 32474 (UDI 10885380128325)Recalls & reported problems

Cardinal Health 200, LLC · SmartGown Breathable Impervious Specialty Gown · 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 10885380128325), received between Mar 16, 2017 and Mar 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

  • Contamination /Decontamination Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 16, 2017Contamination /Decontamination Problem

    A 2-3 CM CIRCULAR HOLE WAS DISCOVERED IN THE FRONT MIDSECTION OF THE GOWN THE SURGEON WAS WEARING WHILE PERFORMING A TOTAL KNEE REPLACEMENT SURGERY. THE SURGEON GAVE THE PATIENT AN EXTRA DOSE OF ANTIBIOTICS DUE TO THE HOLE IN THE GOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6411548 ↗

Other GOWN, SURGICAL devices

All GOWN, SURGICAL devices →

Sources and updates

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