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CARDINAL HEALTH SAN22HCBRKRecalls & reported problems

Cardinal Health 200, LLC · STERILE HEART CATH TRAY · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10887488265247), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 Frayed1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 23, 2020Material Frayed; Material Frayed

    CUSTOMER REPORTED LINTING OF BLUE TOWELS PWTB04-STM FROM THE HEART CATH TRAY PACK SAN22HCBRK ONTO INSTRUMENTS AND PATIENT DURING A CARDIAC CATHETERIZATION PROCEDURE AFFECTING THE STERILE FIELD. TOWELS WERE USED TO DRAPE PATIENT AND TO DRY HANDS OF STAFF. PATIENT DEMOGRAPHICS NOT PROVIDED UPON REQUEST. THERE WAS NO INJURY REPORTED AND PATIENT IS REPORTED AS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11065982 ↗

Other Angiography/angioplasty kit devices

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Sources and updates

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