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Kerlix 6715Recalls & reported problems

Cardinal Health, Inc. · Bandage Roll,100% Cotton, 6 Ply, Large · Class 1

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 10884521058453), received between May 17, 2019 and May 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1
  • Material Frayed1

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.

  • MalfunctionMay 17, 2019Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THE GAUZE WAS NOT USED IN A SURGICAL SETTING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8621263 ↗

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.