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CARDINAL HEALTH SAN55CPMMJRecalls & reported problems

Cardinal Health 200, LLC · CARDIOLOGY PACK MMMC · 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 10888439429282), received between May 11, 2021 and May 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 Separation1

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.

  • MalfunctionMay 11, 2021Material Separation; Material Separation

    CUSTOMER REPORTED THE BLUE COTTON OPERATING ROOM TOWELS PWTB04-STM FROM THE CARDIOLOGY PACK SAN55CPMMJ ARE FRAGMENTING LINT MATERIAL AND ADHERING TO THE SURGICAL DEVICES. ISSUE WAS FOUND DURING SETUP PRIOR TO PATIENT CONTACT. THERE WAS NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11809850 ↗

Other Angiography/angioplasty kit devices

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Sources and updates

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