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Salem Sump 8888265132Recalls & reported problems

Cardinal Health, Inc. · Silicone Dual Lumen Stomach Tube,Radiopaque Line · Class 2

All models of Salem Sump (28)

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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521020092), received between May 5, 2022 and Sep 11, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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-0208-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Separation1
  • Partial Blockage1

Patient problems

  • Discomfort1
  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 11, 2023Material Separation; Material Separation

    THE CUSTOMER REPORTED THAT THE SALEM SUMP WAS REMOVED FROM THE PATIENT WITH THE DISTAL END MISSING. NONE PRESENT IN MOUTH TO SUGGEST PATIENT BITING. 52CM MISSING. ADDITIONAL INFORMATION RECEIVED ON 30AUG2023 STATED THAT THE MISSING PIECE WAS NOT LOCATED NOR REMOVED AS THE PATIENT DIED DUE TO UNRELATED ISSUES.

    Patient problems: Foreign Body In Patient

    MAUDE report 17720953 ↗
  • MalfunctionMay 5, 2022Partial Blockage; Partial Blockage

    CUSTOMER REPORTS: AN NG TUBE WAS PLACED BY NURSING ON A PATIENT CARE UNIT. THE NURSE NOTED THAT THE NG TUBE HAD NO OUTPUT WHEN PLACED TO SUCTION AND THEY WERE UNABLE TO FLUSH THE TUBE. THE SERVICE PLACED AN ORDER TO REPOSITION THE TUBE. THE NURSE WAS STILL UNABLE TO FLUSH THE TUBE AFTER REPOSITIONING, AND THE NG TUBE WAS REMOVED. ONCE REMOVED THE NURSE NOTED THAT THE TUBE WAS DEFECTIVE. THERE WERE NO HOLES OR VENTS AT THE BOTTOM OF THE TUBE.

    Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

    MAUDE report 14287150 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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