Skip to content

Monoject 8881535770Recalls & reported problems

Cardinal Health, Inc. · 35 mL Syringe,Catheter Tip · Class 1

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 20884521012209), received between Feb 15, 2021 and Feb 15, 2021 — 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
  • Device Markings/Labelling Problem1

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.

  • MalfunctionFeb 15, 2021Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

    THE CUSTOMER REPORTED THAT THE SYRINGES HAVE BROKEN TIPS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11329922 ↗

Other Syringe, Irrigating (Non Dental) devices

All Syringe, Irrigating (Non Dental) devices →

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