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Curity 61301Recalls & reported problems

Cardinal Health, Inc. · Gauze Pad · Class 1

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 30884521083947), received between Aug 3, 2020 and Aug 3, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Skin Irritation1

Recent adverse event reports

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

  • InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED THAT THE SPOUSE OF A HOME PATIENT CONTACTED BAXTER BY PHONE AND REPORTED THAT THE PATIENT GOT AN INFECTION ON TUBE SITE AND THE SWABSTICKS (BAXTER PRODUCT CODE EK4061, LOT # UNKNOWN, (B)(4)) WERE MAKING IT IRRITATED AND INFLAMED. THE SKIN GOT SUPER RED AND IT BURNED AND HURT EVERY TIME THEY APPLIED IT. THEY GOT A SET OF IODINE SWABS FROM THE CLINIC THAT THEY ARE USING FOR NOW AND IT DOES NOT IRRITATE THE WOUND. THE PATIENT ALSO USED GAUZE, 2X2 STERILE (PRODUCT CODE EK7417, LOT # UNKNOWN).

    Patient problems: Skin Irritation

    MAUDE report 10360007 ↗

Other Gauze / sponge,nonresorbable for external use devices

All Gauze / sponge,nonresorbable for external use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.