LEUKOSTRIP 13X102MM CTN 50 66002880Recalls & reported problems
Smith & Nephew Medical Limited · Wound closure strips · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05000223449186), received between Mar 16, 2022 and Apr 23, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 reports).
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
- Contamination3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2022Contamination; Contamination
IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE USE, IT WAS CONFIRMED THERE WAS A FOREIGN SUBSTANCE IN THE STERILE POUCH. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191044 ↗MalfunctionApr 5, 2022Contamination; Contamination
IT WAS REPORTED THAT, DURING SET UP FOR WOUND TREATMENT, WAS CONFIRMED A FOREIGN SUBSTANCE ADHERED ON THE STRIP IN ONE DRESSING OF A LEUKOSTRIP 13X102MM CTN 50. AS THIS WAS NOTICED BEFORE TREATMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14018435 ↗MalfunctionMar 16, 2022Contamination; Contamination
IT WAS REPORTED THAT THERE WAS A BLACK STAIN IN THE STRIP OF LEUKOSTRIP 13X102MM CTN 50. AS THIS WAS NOTICED DURING SET UP, THE TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13777974 ↗
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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