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Dover 8946MFRecalls & 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 10884521050655), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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

  • No Flow1

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.

  • MalfunctionJan 11, 2022No Flow; No Flow

    CUSTOMER REPORTS: WHEN THE CATHETER WAS INSERTED TO THE PATIENT, URINE WOULDN'T COME OUT. ONCE THE CATHETER WAS REPLACED, URINE CAME OUT. NO PATIENT HARM. THE CUSTOMER SUSPECTS A PROBLEM WITH THE FIRST CATHETER USED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13225429 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

All COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices →

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