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CARDINAL HEALTH SAN23CCAMKRecalls & reported problems

Cardinal Health 200, LLC · STERILE CARDIAC CATH PACK · 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 00885425856582), received between Oct 5, 2020 and Oct 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1

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.

  • MalfunctionOct 5, 2020Material Fragmentation

    BASED ON INFORMATION RECEIVED BY THE CUSTOMER, LINT FROM OUR OR TOWELS WAS REPORTEDLY DRAWN UP IN THE FLUSH SYRINGE. THERE WAS NO INJURY TO THE PATIENT, THE LINT WAS FOUND PRIOR TO AFFECTING THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10629854 ↗

Other Cardiac catheterization kit devices

All Cardiac catheterization kit devices →

Sources and updates

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