Skip to content

Monoject 8881200318Recalls & reported problems

Cardinal Health, Inc. · Standard Hypodermic Needle,Aluminum Hub · 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 30884521008384), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak1

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 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE DF WAS HAVING DIFFICULTY WITH THOSE NEEDLES ATTACHING TO AN ARTHRAMID SYRINGE. PER CUSTOMER, IF THE CUSTOMER USES A 20G NEEDLE HE DOES NOT HAVE PRODUCT LOSS AND WHEN HE USES 21G, HE ALWAYS HAS A DROP ESCAPE THE NEEDLE/HUB CONNECTION AND WAS CONCERNED THERE MAY HAVE BEEN A MANUFACTURING ISSUE. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18628080 ↗

Other Needle, hypodermic, single lumen devices

All Needle, hypodermic, single lumen devices →

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