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Salem Sump 8888264945 (UDI 10884521007697)Recalls & reported problems

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

All models of Salem Sump (28)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521007697), received between Sep 26, 2019 and Aug 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (3 reports).

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.

Most reported problems

Device problems

  • Crack3
  • Suction Problem3
  • Break1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 13, 2020Break; Break

    THE CUSTOMER REPORTED THE RN OPENED A NEW NG TUBE PACKAGE PRIOR TO INSERTION AND NOTICED THAT THE TIP WAS PARTIALLY BROKEN OFF.

    Patient problems: No Patient Involvement

    MAUDE report 10403824 ↗
  • MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem

    THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9126400 ↗
  • MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem

    THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9126390 ↗
  • MalfunctionSep 26, 2019Crack; Suction Problem; Crack; Suction Problem

    THE CUSTOMER REPORTED THAT THERE WAS A SUSPECTED FINE CRACK IN THE TUBING, RESULTING IN INEFFECTIVE ASPIRATION OF THE TUBE WITH A SIMULTANEOUS FAINT SOUND OF AIR. THE PATIENT HAD THE TUBE INSERTED THE DAY PRIOR. THE CUSTOMER FURTHER STATED THE PRODUCT FAILED TO ASPIRATE THE GASTRIC FLUIDS BECAUSE IT WAS SPLIT AND SPILLING OUT OF THE SIDES. THE TUBING HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9126331 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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