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CARDINAL HEALTH SANHFIRSHFRecalls & reported problems

Cardinal Health 200, LLC · CPT, BASIC IR 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 10888439588224), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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 Disintegration1

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.

  • MalfunctionFeb 3, 2021Material Disintegration; Material Disintegration

    CUSTOMER REPORTED THAT THE TOWELS PWTB04-STM FROM THE BASIC IR PACK SANHFIRSHF ARE GETTING LINT BALLS ON THEM DURING AN ANGIOGRAM PROCEDURE. THE PARTICULATES ARE ALSO FROM THE FOAM TRAY. THIS IS PROBLEMATIC BECAUSE THEY CAN BECOME AN EMBOLIC FOR THE PATIENT. THERE WAS NO INJURY OR DELAY REPORTED. REPORT BEING FILED FOR POTENTIAL FOR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11276307 ↗

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Sources and updates

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