Excelsior E0100-55Recalls & 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 10363807100555), received between Aug 21, 2024 and Sep 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

Material Twisted/Bent1
Unsealed Device Packaging1

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.

MalfunctionSep 23, 2026Unsealed Device Packaging
It was reported that Posiflush we received have no plastic bag covering them therefore making them non-sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868754 ↗
MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent
ACCORDING TO THE CUSTOMER, "SOME OF THE FLUSHES IN THE BOX ARE BENT/WARPED PLUNGERS AND WON'T FUNCTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20022528 ↗

Device details

UDI-DI	`10363807100555`
Brand	Excelsior
Model	E0100-55
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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All Saline, vascular access flush devices →

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