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Monoject 8881225245Recalls & reported problems

Cardinal Health, Inc. · True content to be populated as part of rebranding · Class 2

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 10884521013254), received between Jan 10, 2020 and Jan 10, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 10, 2020Break; Break

    THE CUSTOMER REPORTED THAT THE MALE BLOOD CULTURE HUB WITH THE INTERNAL NEEDLE ARE BREAKING OFF DURING COLLECTION. THE CUSTOMER FURTHER STATED THAT THE NEEDLE INSIDE THE HUB SEEMS TO BE LESS STURDY THAN BEFORE. AFTER CHANGING OUT THE TUBES, THE NEEDLE WOULD BEND OR BREAK. THERE HAVE BEEN NO EXPOSURES AT THIS TIME. NO HARM TO THE CLINICIAN AND THE PATIENT INVOLVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9578424 ↗

Other Tubes, vacuum sample, with anticoagulant devices

All Tubes, vacuum sample, with anticoagulant devices →

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