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CONVERTORS AT74531Recalls & reported problems

Cardinal Health 200, LLC · Procedure Mask W/Anti-Fog Foam Strip · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20885380072113), received between Jan 24, 2017 and May 31, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Patient-Device Incompatibility1

Patient problems

  • Rash3
  • Swelling1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 31, 2020Adverse Event Without Identified Device or Use Problem

    EMPLOYEE IN IMAGING SERVICES REPORTED DEVELOPING SKIN IRRITATION/RASH AFTER WEARING MASK. EMPLOYEE HAS A LATEX ALLERGY. SHE WENT TO THE EMERGENCY DEPARTMENT WITH EYE SWELLING AND WAS GIVEN ORAL PREDNISONE. EMPLOYEE FINISHED PREDNISONE DOSE PACK AND REPORTS SHE IS DOING FINE NOW.

    Patient problems: Rash

    MAUDE report 10103897 ↗
  • InjuryFeb 17, 2019Adverse Event Without Identified Device or Use Problem

    NURSE¿S FACE WAS ITCHY/RED/BROKE OUT IN RASH AND HIVES; AND LATER THAT NIGHT HER FACE BECAME SWOLLEN. THE NEXT DAY SHE WENT TO THE URGENT CARE BECAUSE HER FACE WAS STILL SWOLLEN AND BROKEN OUT. SHE RECEIVED A STEROID INJECTION, PO STEROIDS, AND PO ANTIHISTAMINES. THESE HELPED, AND HER FACE WENT BACK TO NORMAL WITHIN A FEW DAYS.

    Patient problems: Rash; Swelling

    MAUDE report 8346505 ↗
  • InjuryJan 24, 2017Patient-Device Incompatibility

    NURSE HAD BEEN USING MASK WITHOUT PROBLEMS. ON (B)(6) 2016 NURSE HAD HER NOSE, CHEEKS, BEHIND HER EARS, AND ARMS BREAK OUT WITH A RASH. SHE WENT TO OCCUPATIONAL HEALTH AND WAS GIVEN AN ANTIHISTAMINE AND TOPICAL OINTMENT.

    Patient problems: Rash

    MAUDE report 6274370 ↗

Other Mask, surgical devices

All Mask, surgical devices →

Sources and updates

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