CARDINAL HEALTH SCV13VUCOLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197106566756), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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

Recent adverse event reports

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

• MalfunctionJun 16, 2025Delivered as Unsterile Product; Product Quality Problem; Device Damaged Prior to Use; Contamination of Device Ingredient or Reagent

  OPERATING ROOM STAFF WAS PREPARING TO PERFORM A PROCEDURE, AND AS THEY TOOK OUT THE CARDINAL HEALTH "VASCULAR U BAR PACK" AND NOTICED THERE WAS A LARGE HAIR UNDER THE TAPE AND OUTER PLASTIC PACKAGING. A NEW STERILE TRAY WAS RETRIEVED AND USED WITHOUT ISSUE. OVER THE LAST TWO WEEKS, WE HAVE FOUND FOUR DIFFERENT TRAYS WITH HAIR IN THEM, ONE "TOTAL HIP" PACK, ONE "CYSTO PACK", AND ONE "MINOR U BAR PACK". ALL TRAYS WERE UNUSED, AND IT WAS CAUGHT BEFORE THE TRAY WAS USED ON A PATIENT. MANUFACTURER RESPONSE FOR CARDIOVASCULAR PROCEDURE KIT, CARDINAL HEALTH (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210795 ↗