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Dover 6158MFRecalls & reported problems

Cardinal Health, Inc. · Latex Foley Catheter Tray,Closed System · Class 2

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 10884521050563), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE CATHETER CAME OFF OF THE TUBE OF THE BAG DURING USE. IT APPEARED THAT THE CONNECTION WAS LOOSE. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10712366 ↗

Other Urinary Drainage Collection Kit devices

All Urinary Drainage Collection Kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.