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CONVERTORS 9545ELARecalls & reported problems

Cardinal Health 200, LLC · Non-Reinf Surgical Gown, XL, Long · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253010565), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

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

  • Erythema1
  • Skin Irritation1

Recent adverse event reports

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

  • InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER REPORTED A NURSE DEVELOPED REDNESS AND HIVES ON HER ARMS WHILE WEARING AAMI LEVEL 3 NON-REINFORECED SURGICAL GOWN XL 9545 REQUIRING AN INTRAMUSCULAR STEROID INJECTION AND ORAL BENADRYL. SHE HAS HISTORY OF ALLERGY TO FORMALDEHYDE. THE EVENT DATE IS UNKNOWN BY THE CUSTOMER. REPORT FILED FOR SERIOUS INJURY.

    Patient problems: Erythema; Skin Irritation

    MAUDE report 10549976 ↗

Other GOWN, SURGICAL devices

All GOWN, SURGICAL devices →

Sources and updates

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