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Dover 3450Recalls & reported problems

Cardinal Health, Inc. · Closed Urethral Tray with Vinyl Catheter,1000 mL Bag, Prepping Components · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521009479), received between Feb 24, 2020 and Feb 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Nov 1, 2022Open, Classified

    Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

    Z-0360-2023 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Device problems

  • Disconnection1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 24, 2020Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT THE CONNECTION BETWEEN THE CATHETER AND THE BAG COMES APART EASILY WHEN INSERTING THE LINE INTO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9746170 ↗

Other Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices

All Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) devices →

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