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Euromi

Euromi · Model 1214LVITW-4.5250 · UDI-DI 03701416201643

GEA

510(k) clearances

1,037

Adverse events (1 deaths)

Recalls

377

Facilities

Description

The cannulas are reusable medical devices intended to be used by healthcare professionals for surgical or aesthetic applications. They are designed for the injection, irrigation, or aspiration of biological fluids, depending on their configuration. Manufactured from stainless steel or tungsten, they provide excellent mechanical and chemical resistance, ensuring durability and compatibility with standard cleaning, disinfection, and sterilization processes commonly used in the medical field. The cannulas are supplied non-sterile and must be thoroughly cleaned and sterilized before each use. They are available in various lengths, diameters, and tip configurations depending on the intended use, and are designed to ensure precise, safe, and comfortable handling.

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2021-04-01	CLINICAL LASERTHERMIA SYSTEMS AB	single use devices labeled as sterile may not have been adequately sterilized
2020-01-15	Cardinal Health 200, LLC	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile
2019-07-16	TeDan Surgical Innovations LLC	There was incorrect raw material used in the production of the identified lot.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.