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CARDINAL HEALTH SAN22CPBM3Recalls & reported problems

Cardinal Health 200, LLC · 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 10888439444476), received between Jun 11, 2019 and Jun 11, 2019 — 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 Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 11, 2019Material Frayed

    THE CUSTOMER REPORTED LINTING OF THE BLUE NON-XRAY TOWELS (B)(4) FROM THE CATHETERIZATION KIT SAN22CPBM3. NO DETAILED COMPLAINT INFORMATION, PATIENT DEMOGRAPHICS OPERATING ROOM CLINICAL DATA WAS PROVIDED AFTER MULTIPLE ATTEMPTS TO RETRIEVE FROM CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. AN MDR IS BEING FILED BASED ON POTENTIAL RISK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8687069 ↗

Other Angiography/angioplasty kit devices

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Sources and updates

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