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Monoject 11811022FRecalls & reported problems

Cardinal Health, Inc. · Bluntfill with Filter · Class 1

All models of Monoject (164)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521544833), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionMar 9, 2023Break; Break

    THE CUSTOMER REPORTED WHEN THEY TIGHTENED THE LUER LOCK NEEDLE, THE HUB BROKE. THIS HAPPENED TWO TIMES WITH THE SAME LOT NUMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16512471 ↗

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Sources and updates

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