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Monoject 11812705 (UDI 10192253025149)Recalls & reported problems

Cardinal Health 200, LLC · 1 mL Syringe with Hypodermic Safety Needle · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253025149), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. May 9, 2024Open, Classified

    Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

    Z-3074-2024 · Root cause: Other · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1

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.

  • MalfunctionNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER REPORTS: THERE ARE ISSUES WITH THE NEEDLE NOT BEING PROPERLY ATTACHED TO THE HUB. THEY MUST TIGHTEN EACH ONE THAT THEY OPEN TO AVOID A POSSIBLE NEEDLE STICK OR A NEEDLE FALLING OFF DURING A PROCEDURE. ADDITIONAL INFORMATION PROVIDED ON 11/11/22 STATED THAT THERE WERE NO PATIENT INJURIES BECAUSE THE NEEDLE IS NOT USED ON PATIENTS. THE LAB TECHS USE THEM TO GET THE BLOOD SAMPLES OUT OF THE BLOOD CULTURE BOTTLES TO PLATE FOR MICROBIOLOGY. THERE WAS A TECH THAT WAS SCRATCHED WITH ONE OF THE NEEDLES WHEN IT FELL OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15819813 ↗

Other Syringe, piston devices

All Syringe, piston devices →

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