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Salem Sump 264945Recalls & reported problems

Cardinal Health 200, LLC · Stomach Tube Dual Lumen 14 Fr/Ch (4.7 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 10884521067202), received between Jul 23, 2021 and Jul 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionJul 23, 2021Break; Break

    THE CUSTOMER REPORTED THE LAST CENTIMETER OF THE SALEM SUMP TUBE WHICH IS INSERTED INTO THE STOMACH WAS BENT OVER AND TORN. THIS WAS NOTICED BEFORE USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12217280 ↗

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.