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Monoject 8881570121DRecalls & reported problems

Cardinal Health, Inc. · Monoject™ 0.9% Sodium Chloride Prefilled Flush Syringe, 10ML Fill, 12ML Syringe · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521750173), received between May 1, 2020 and Aug 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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.

Most reported problems

Device problems

  • Infusion or Flow Problem1
  • Material Discolored1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

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

  • MalfunctionAug 25, 2020Infusion or Flow Problem; Infusion or Flow Problem

    THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PRIME TUBING WITH THE FLUSH, IF THEY DO NOT HOLD THE PLUNGER OR CLAMP THE TUBING IT BACKS UP WITH AIR.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10448234 ↗
  • MalfunctionMay 1, 2020Material Discolored; Material Discolored

    THE CUSTOMER REPORTED THAT THE SALINE SOLUTION INSIDE OF THE SYRINGES WAS CLOUDY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10018988 ↗

Other Saline, vascular access flush devices

All Saline, vascular access flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.