Kerlix 3332Recalls & reported problems
Cardinal Health, Inc. · AMD Antimicrobial Bandage Roll,6 Ply · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521020037), received between Sep 3, 2017 and Feb 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Disintegration” (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 18, 2026.
Most reported problems
Device problems
- Material Disintegration1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2023Material Disintegration; Material Disintegration
THE CUSTOMER REPORTED THAT THEY HAVE RECENTLY BEEN NOTICING MORE ISSUES WITH LOOSE THREADS FROM THE KERLIX AS MOST PEOPLE DON¿T USE THE WHOLE ROLL AND MUST CUT THE ROLL SHORTER. ONCE CUT, THE ENDS ARE CONSTANTLY FLAKING OFF THREADS THAT GET STUCK ON THEIR WOUNDS BASE. PER CUSTOMER, ONE OF THE SURGEONS ASKED TO STOP USING IT ON HIS PATIENT. THE CUSTOMER IS CONCERNED ABOUT A FOREIGN BODY BEING LOOSE ON WOUND BEDS AS THEY ARE SMALL AND SOMETIMES NOT REMOVED BY JUNIOR STAFF DURING DRESSING CHANGES. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THIS GAUZE IS BEING USED ON SURGICAL ABDOMINAL WOUND AND COCCYX PRESSURE INJURIES. PER CUSTOMER, THE KERLIX GAUZE IS BEING USED IN BOTH SURGICAL SETTING AND NON-SURGICAL SETTING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16292621 ↗MalfunctionSep 3, 2017Material Frayed; Material Frayed
THE CUSTOMER REPORTS THAT THE ROLLS ARE COUNTED AND LOGGED INTO THE WOUND; HOWEVER, UPON OPENING, THE SURGEON UNRAVELED THE ROLL TO DISCOVER THAT IT CONSISTED OF TWO ENDS OF GAUZE STRIP TIED ROUGHLY TOGETHER, WITH MANY FRAYED LOOSE FIBERS. THE KERLIX BANDAGE ROLL WAS OPENED FOR USE INSIDE A RIGHT CALF WOUND. THE CUSTOMER FURTHER REPORTS THAT THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6840719 ↗
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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