Dover 6165LLRecalls & reported problems
Cardinal Health, Inc. · Hydrogel Coated Latex Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-Connected to 2000 mL Drainage Bag with Luer-Lock Sampling · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521015555), received between Aug 11, 2021 and Aug 11, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionAug 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THERE WAS A DISCONNECTION ISSUE WITH 6165LL. THE EVENT OCCURRED BEFORE PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12309774 ↗
Other Urinary drainage collection kit, for indwelling catheter devices
- SteriGear A4092-81Sterigear, LLC · Urinary drainage collection kit, for indwelling catheter1 recall0 reports
- Dover FPP12ULCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
- 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
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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