Dover FPP12ULRecalls & reported problems
Cardinal Health, Inc. · Drainage Bag with Catheter,12 Fr/Ch (4.0 mm), 5 mL Hydrogel Coated Catheter Pre-connected to 2000 mL Drainage Bag, Luer-Lock Sampling with Top Vent, Anti-Reflux Device, Drain Spout · Class 2
All models of Dover (90)
Data updated Oct 16, 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 10884521046702), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- No Flow1
Patient problems
- Pain1
- Urinary Retention1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2020No Flow; No Flow
THE CUSTOMER REPORTED THAT THE INDWELLING CATHETER WAS DEFECTIVE, DESPITE CHECKING THE BALLOON (NON-POROUS) AND LEAKAGE, THERE WAS POOR EMPTYING. THE PROBE WAS REMOVED, AND A NEW FUNCTIONAL CH14 INDWELLING PROBE WAS INSERTED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS A POOR URINE DRAINAGE. THE PATIENT EXPERIENCED ACUTE URINE RETENTION AND HYPERALGESIA, AS THE RESULT OF THE PRODUCT MALFUNCTION. THE CUSTOMER HAD CONTACTED THE NURSE AND THE NURSE EXPLAINED THAT, SHE DID A TEST ON THE BALLOON, WHICH DID NOT SHOW ANY POROSITY. THE CATHETER WAS ALSO TESTED WITHOUT ANY OBSTACLES. THE URINE WAS CLEAR. THERE WERE NO SPECIFIC PROBLEMS WITH THE TESTS, BUT DUE TO THE INCREASE IN VESICULAR GLOBE AND URINE RETENTION WITH STRONG PAIN, IT WAS DECIDED TO REPLACE THE CATHETER WITH A NEW CATHETER WITH A LARGER HINGE AND THE PROBLEM WAS RESOLVED. IT WAS UNKNOWN IF ANY TREATMENT WAS PROVIDED FOR THE ACUTE URINARY RETENTION ISSUE AND HYPERALGESIA.
Patient problems: Pain; Urinary Retention
MAUDE report 10614209 ↗
Other Urinary drainage collection kit, for indwelling catheter devices
- SteriGear A4092-81Sterigear, LLC · Urinary drainage collection kit, for indwelling catheter1 recall0 reports
- Dover FPP18ULCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
- Dover P4P16CSDK2Cardinal Health 200, LLC · Urinary drainage collection kit, for indwelling catheter1 report
- Dover 6165LLCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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