Dover 6308Recalls & reported problems
Cardinal Health 200, LLC · MONOFLO URINE BAG PREMIUM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521002050), received between Dec 13, 2021 and Jan 25, 2022 — classified as 2 malfunctions.
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
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2022Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT CLOGGING OCCURRED AT THE ROUND PART WHERE THE TUBE AND BAG ARE CONNECTED. THERE WAS NO PATIENT HARM. THE DURATION OF USE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13348775 ↗MalfunctionDec 13, 2021No Flow; No Flow
THE CUSTOMER REPORTED THEY ATTACH THE BAG TO THEIR STOMA BUT THE BAG FULLY EXPANDS AT NIGHT AND WILL NOT ALLOW URINE TO GO IN. THIS STARTED IN RECENT MONTHS, AND FORCES THE PATIENT TO WAKE UP FREQUENTLY TO RELEASE THE AIR. NO FURTHER DETAILS WERE ABLE TO BE OBTAINED AS THE INITIAL REPORTER'S INFORMATION WAS NOT PROVIDED UPON INTAKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12987516 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.