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CARDINAL HEALTH SOPDKHDFLBRecalls & reported problems

Cardinal Health 200, LLC · STERILE HAND PACK · Class 1

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488478753), received between Feb 6, 2017 and Feb 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Itching Sensation1
  • Reaction1

Recent adverse event reports

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

  • InjuryFeb 6, 2017Patient-Device Incompatibility

    BASED ON THE REPORT RECEIVED A TECH HAD A REACTION TO THE SET UP GOWN (90380NC). TECH WAS PRESCIBED A 10-DAY COURSE OF DEXAMETHASONE AND HAS BEEN USING OWN ALOE/VITAMIN E CREAM FOR ITCHING.

    Patient problems: Itching Sensation; Reaction

    MAUDE report 6305439 ↗

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Sources and updates

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