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Liebel-Flarsheim Company LLC: FDA-registered device maker in Cincinnati, OH, United States, 13 510(k) clearances

Name: Liebel-Flarsheim Company LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Liebel-Flarsheim Company LLC is registered with the FDA (registration 1518293) in Cincinnati, OH, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 29, 2025. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1518293
Address: 2111 East Galbraith RD., Cincinnati, OH, United States, 45237
Owner or operator: Guerbet LLC / Liebel-Flarsheim Company LLC (10050387)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Specification developer
First device listed: November 13, 2015
Registered through: 2026
Brand names listed: Angiomat 6000, Angiomat Illumena, Disposable Syringe Fill Tube, L-F Coiled Extension Tubing, OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System, OptiStar Elite Injection System, OptiStar MR Injector System, OptiVantage DH Injector System with Enhanced Communication and more

Devices it lists

Device	Product code	Class	Role	Source
Injector And Syringe, Angiographic	DXT	2	Manufacturer, Remanufacturer, Specification developer	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Complaint file establishment	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 29, 2025	K242255	Qitexio® 4-Way Stopcock (QIT014)	FMG	Substantially Equivalent	Medex	accessdata.fda.gov
March 14, 2022	K203738	Qitexio	FMF	Substantially Equivalent	Medex	accessdata.fda.gov
January 14, 2016	K152361	OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System	IZQ	Substantially Equivalent	Liebel-Flarsheim Company, LLC	accessdata.fda.gov
May 7, 2008	K073592	OPTISTAR ELITE INJECTION SYSTEM	DXT	Substantially Equivalent	Mallinckrodt Inc., Liebel-Flarsheim Business	accessdata.fda.gov
April 27, 2007	K063503	OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION	IZQ	Substantially Equivalent	Mallinckrodt Inc., Liebel-Flarsheim Business	accessdata.fda.gov
November 30, 2004	K042744	OPTIV ANTAGE DH POWER INJECTION SYSTEM	DXT	Substantially Equivalent	Mallinckrodt Inc., Liebel-Flarsheim Business	accessdata.fda.gov
December 6, 1999	K984088	OPTISTAR MR INJECTOR SYSTEM	DXT	Substantially Equivalent	Mallinckrodt Inc., Liebel-Flarsheim Business	accessdata.fda.gov
September 23, 1997	K963071	ANGIOMAT ILLUMENA	DXT	Substantially Equivalent	Mallinckrodt Inc., Liebel-Flarsheim Business	accessdata.fda.gov
February 4, 1992	K912944	CT 8000 DIGITAL INJECTION SYSTEM	DXT	Substantially Equivalent	Mallinckrodt Group, Inc.	accessdata.fda.gov
September 2, 1988	K882329	L-F COILED EXTENSION TUBING	DXT	Substantially Equivalent	Mallinckrodt Group, Inc.	accessdata.fda.gov
May 2, 1986	K860204	ANGIOMAT 6000	DXT	Substantially Equivalent	Mallinckrodt Group, Inc.	accessdata.fda.gov
December 3, 1982	K823356	READY-BOX BODY-TEMP MEDIA WARMER MALLIN-	DXT	Substantially Equivalent	Forma Scientific, Inc.	accessdata.fda.gov
August 17, 1978	K781334	DISPOSABLE SYRINGE FILL TUBE	DXT	Substantially Equivalent	Mallinckrodt Group, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 25, 2013	65176	Class II	Terminated	Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.	A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.	accessdata.fda.gov
February 10, 2012	61187	Not yet classified	Terminated	Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. Sterile, The purpose of this pr	The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.	accessdata.fda.gov
December 20, 2011	60897	Not yet classified	Terminated	Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approxim	The firm received complaints from their customers stating that they found open seals on two of their sterilized products.	accessdata.fda.gov
October 11, 2011	60874	Not yet classified	Terminated	Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illume	Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.	accessdata.fda.gov
May 20, 2011	59103	Not yet classified	Terminated	Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use w	Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.	accessdata.fda.gov
June 14, 2010	55953	Not yet classified	Terminated	Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requirin	Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.	accessdata.fda.gov
February 1, 2010	54724	Class II	Terminated	The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube i	A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.	accessdata.fda.gov
April 14, 2008	47889	Not yet classified	Terminated	Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.	The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.	accessdata.fda.gov
April 7, 2008	47766	Not yet classified	Terminated	The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipm	Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.	accessdata.fda.gov
August 24, 2007	39408	Not yet classified	Terminated	Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.	Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the	accessdata.fda.gov
November 7, 2006	36811	Not yet classified	Terminated	OptiVantage DH Power Injection System.	The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than d	accessdata.fda.gov

Compare with other makers

Updated April 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.