Excelsior 10051Recalls & reported problems

Medline Industries, Inc. · 0.9% Sodium Chloride Injection, USP · 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 00363807000056), received between Mar 5, 2024 and Mar 7, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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

Crack2
Leak/Splash2

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.

MalfunctionMar 7, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE SYRINGES HAVE "CRACKS" AND ARE "LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856117 ↗
MalfunctionMar 5, 2024Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE SYRINGES ARE FOUND WITH CRACKS AND LEAKING SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18841553 ↗

Device details

UDI-DI	`00363807000056`
Brand	Excelsior
Model	10051
Catalog no.	151-240
Company	Medline Industries, Inc.
Product code	NGT · Saline, vascular access flush
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Vascular catheter flush syringe

A sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. 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.