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Salem Sump 266130Recalls & reported problems

Cardinal Health 200, LLC · Stomach Tube Dual Lumen with Anti-Reflux Valve 16 Fr/Ch (5.3 mm) · 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
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 10884521065031), received between Jan 4, 2022 and Jun 12, 2024 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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-0210-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Nonstandard Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Vomiting1

Recent adverse event reports

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

  • MalfunctionJun 12, 2024Break; Break

    THE CUSTOMER REPORTED THAT WHEN USING THE TUBE, THE TIP GETS STUCK IN THE CATHETER AND POSSIBILITY OF CLOSING OR GENTLY SUCTIONING THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT REPEATED CONNECTION/DISCONNECTION OF THE VALVE WAS THE SOURCE OF THE VALVE BREAK PROBLEM. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19523929 ↗
  • MalfunctionJan 4, 2022Nonstandard Device; Nonstandard Device

    THE CUSTOMER STATES THAT THE PATIENT EXPERIENCED MESENTHEREAL ISCHEMIA AND HAD A BLOCKED STOMACH. AS A RESULT, THE TUBE WAS PLACED FOR SUCTION AND PLACEMENT WAS CONFIRMED BY THE SURGEON. THE PATIENT EXPERIENCED EPISODES OF VOMITING AND IT WAS DISCOVERED THAT THERE WERE NO HOLES AT THE END OF THE TUBING. THERE WAS NO SUCTION PROVIDED THROUGH THE TUBE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THE TUBE WAS REPLACED.

    Patient problems: Vomiting

    MAUDE report 13155315 ↗

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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