Equashield Equashield Syringe Unit (UDI 07290013484048)Recalls & reported problems

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 07290013484048), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.

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

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 26, 2025
WHEN ATTEMPTING TO PULL PLUNGER FROM SYRINGE, PLUNGER DIDN'T MOVE BUT ENTIRE METAL BARREL CAME OUT OF END OF SYRINGE. IF THERE HAD BEEN A HAZARDOUS MEDICATION IN THE SYRINGE IT WOULD HAVE SPILLED OR BEEN A COMPLETE LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468712 ↗

Device details

UDI-DI	`07290013484048`
Brand	Equashield
Model	Equashield Syringe Unit
Company	Equashield Medical Ltd
Product code	ONB · Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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	In Commercial Distribution
Record updated	Jul 13, 2023

Device type (GMDN): Medication transfer set

A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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.