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Monoject 8881225265Recalls & reported problems

Cardinal Health, Inc. · Blood Collection Set with Tube Holder,Attached 12 inch (30.5 cm) Tubing · 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 10884521013285), received between Nov 24, 2021 and Sep 23, 2022 — classified as 2 malfunctions.

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
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionSep 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER REPORTS: THE NEEDLE REMAINED IN THE PATIENTS ARM AND THE NURSE WAS ABLE TO REMOVE IT, SO NO HARM WAS DONE AND THEY ARE DOING X-RAYS TO BE SURE. THE PRODUCT WAS PULLED OFF OF THE SHELVES, IT IS ONLY USED IN THE EMERGENCY ROOM DEPARTMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15470455 ↗
  • MalfunctionNov 24, 2021Break; Break

    THE CUSTOMER REPORTED THAT THERE WAS A BROKEN WING ON THE BLOOD COLLECTION DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12868799 ↗

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.