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Salem Sump 264929Recalls & reported problems

Cardinal Health 200, LLC · Stomach Tube Dual Lumen 12 Fr/Ch (4.0 mm) · 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 10884521067196), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. Sep 18, 2025Open, Classified

    Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

    Z-0207-2026 · Root cause: Use error · FDA record ↗

Most reported problems

Device problems

  • Leak/Splash1

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.

  • MalfunctionOct 23, 2017Leak/Splash; Leak/Splash

    ACCORDING TO THE REPORTER, THE DEVICE HAD AIR LEAKAGE AT THE PROBE JUNCTION AND THE PIPE USED TO SEAL THE PROBE JUNCTION. STATUS OF PATIENT OUTCOME WAS UNKNOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6969756 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

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