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Salem Sump 8888264929ERecalls & reported problems

Cardinal Health 200, LLC · Salem Sump Dual Lumen Stomach Tube with ENFit Connection · Class 2

All models of Salem Sump (31)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10884521779426), received between Jun 9, 2022 and Jun 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Sep 18, 2025Class IIOpen, 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-0206-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Nonstandard Device1

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.

  • MalfunctionJun 9, 2022Nonstandard Device; Nonstandard Device

    THE CUSTOMER REPORTED THAT AFTER SEVERAL ATTEMPTS TO PLACE A NASOGASTRIC SALEM SUMP WITHOUT SUCCESS, IT WAS NOTICED THAT THE TUBE WAS NOT PATENT AND IN FACT HAD NO HOLES IN THE END OF IT. PER ADDITIONAL INFORMATION RECEIVED ON 01JUN2022, THE DEVICE WAS REPLACED. THERE WAS NO MEDICAL INTERVENTION GIVEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14642653 ↗

Other TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION devices

All TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION devices →

Sources and updates

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