CARDINAL HEALTH SNE59CNKSORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439602913), received between Jan 14, 2021 and Jan 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Nov 8, 2024Class IIOpen, Classified

   Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

   Z-0915-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Nov 8, 2024Class IIOpen, Classified

   Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

   Z-1134-2025 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 14, 2021Material Separation; Material Separation

  PT REPORTED THAT THE BLUE TOWELS OR-1727BXG FROM THE CRANIOTOMY PACK SNE59CNKSO WERE LINTING AND SOME OF THE LINT GOT INTO THE SURGICAL FIELD DURING A CRANIOTOMY. THE TOWELS WERE USED TO DRAPE THE MAYO STAND. LINT WAS FOUND ON THE BRAIN WHICH WAS REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OR ADVERSE EFFECT WAS REPORTED. PATIENT DEMOGRAPHICS WERE NOT PROVIDED WHEN REQUESTED. REPORT BEING FILED FOR POTENTIAL FOR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174760 ↗