Monoject 8881520657 (UDI 20192253035442)Recalls & reported problems

Cardinal Health, Inc. · 20 mL Syringe Luer-Lock Tip · 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 20192253035442), received between May 4, 2024 and May 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1

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.

MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEIR ANESTHESIA DOCS ARE REPORTING ISSUES USING THE REPORTED SYRINGE. WHEN THEY DRAW THE MEDS, THE PLUNGER IS LOOSE AND SLIDES BACK. THIS HAS BEEN USED WHEN DRAWING UP PROPOFOL. THEY HAVE PULLED THE LOT FROM SERVICE.NO INJURY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244512 ↗

Device details

UDI-DI	`20192253035442`
Brand	Monoject
Model	8881520657
Company	Cardinal Health, Inc.
Product code	FMF · Syringe, piston
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 30, 2025

Device type (GMDN): General-purpose syringe, single-use

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

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