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Becton Dickinson Infusion Therapy Systems Inc.

United States·US-MF-000017719

Last updated September 17, 2026

What Becton Dickinson Infusion Therapy Systems Inc. makes

Becton Dickinson Infusion Therapy Systems Inc. manufactures a range of single-use intravenous (IV) catheters, including the Venflon line, designed for peripheral venous access in clinical settings. These catheters are intended for administering fluids, medications, and blood products, as well as for drawing blood samples. The products are engineered for ease of insertion and secure placement to minimise complications during infusion therapy.

The company’s devices are classified under EU regulations as Class I (low-risk) and Class II/IIa (moderate-risk), with corresponding submissions in the EUDAMED database. In the US, these products are subject to 510(k) clearance via the FDA. The manufacturer operates from the United States and maintains listings in both regulatory registries.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Becton Dickinson Infusion Therapy Systems Inc. manufacture?

Becton Dickinson Infusion Therapy Systems Inc. specialises in single-use intravenous (IV) catheters, specifically the Venflon line. These catheters are designed for peripheral venous access in clinical environments, enabling the administration of fluids, medications, blood products, and blood sampling. The devices are engineered for ease of use and secure placement to reduce risks during infusion therapy.

Where is Becton Dickinson Infusion Therapy Systems Inc. based?

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory submissions and listings reflect its operations within the US market.

Which regulatory registries list the devices manufactured by Becton Dickinson Infusion Therapy Systems Inc.?

The company’s devices are listed in EUDAMED under EU regulations and in the FDA’s 510(k) database for US clearance. These registries track authorised devices under their respective classification systems.

How are the devices from Becton Dickinson Infusion Therapy Systems Inc. classified under EU and US regulations?

Under EU regulations, the Venflon catheters are classified as Class I (low-risk) or Class II/IIa (moderate-risk), depending on their design and intended use. In the US, these devices undergo 510(k) clearance through the FDA to demonstrate substantial equivalence to legally marketed predecessors. Classification determines the regulatory pathway and scrutiny required for authorisation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 9450, South State Street, Sandy, United States
Website: No website
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 801 230 5783
PRRC Contact: Nitin Patil
EUDAMED SRN: US-MF-000017719
FDA FEI Number: 1710034
DUNS Number: —

Catalogue (69)

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Device	Model / Reference	Registries	Class	Status
Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, And Saf-T-Intima Intravascular Cathete	K013800	FDA 510(k)	Class II	Active
Bd Nexiva Diffusics Closed Iv Catheter System	K123734	FDA 510(k)	Class II	Active
Bd Posiflow Positive Displacement Valve	K050207	FDA 510(k)	Class II	Active
Nexiva™ Closed IV Catheter System with NearPort™ IV Access	K231239	FDA 510(k)	Class II	Active
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector	K250682	FDA 510(k)	Class II	Active
Bd Introsyte Precision Introducer; Bd Introsyte-N Precision Introducer; Bd Introsyte Autoguard Shielded Introducer; Bd I	K020834	FDA 510(k)	Class II	Active
Bd Insyte Autoguard -p And Bd Insyte Autoguard -p Winged Iv Catheters	K002033	FDA 510(k)	Class II	Active
Bd Onecath	K042862	FDA 510(k)	Class II	Active
First Midcath Catheter	K972264	FDA 510(k)	Class II	Active
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector	K233529	FDA 510(k)	Class II	Active
Nexiva	383694	EUDAMED	Class IIa	Active
Neoflon	391389	EUDAMED	Class IIa	Active
Saf-T-Intima	383339	EUDAMED	Class IIa	Active
Saf-T-Intima	383338	EUDAMED	Class IIa	Active
Nexiva	383692	EUDAMED	Class IIa	Active
Nexiva	383695	EUDAMED	Class IIa	Active
Saf-T-Intima	383318	EUDAMED	Class IIa	Active
Nexiva	383691	EUDAMEDFDA 510(k)FDA UDI	Class IIa	Active
Neoflon	391390	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Becton Dickinson Ireland Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Becton Dickinson Infusion Therapy Systems Inc. has 15 recall records initiated between September 8, 2021, and May 21, 2025, with statuses recorded as either open or classified. The reasons cited include packaging breaches compromising sterility, defects such as holes in catheter tubing or septa, improper needle retraction or disengagement from safety shields, and potential slow or failed needle retraction during use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 21, 2025	Z-2003-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2002-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-1999-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2007-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2000-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2004-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2005-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2001-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
May 21, 2025	Z-2006-2025	—	open, classified	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Apr 21, 2025	Z-1808-2025	—	open, classified	Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
Jun 26, 2024	Z-2458-2024	—	open, classified	Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Oct 4, 2023	Z-0400-2024	—	open, classified	Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
Aug 29, 2023	Z-0025-2024	—	open, classified	There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
Oct 12, 2022	Z-0174-2023	—	open, classified	During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Sep 8, 2021	Z-0306-2022	—	open, classified	There is a breach in the product packaging that renders the product non-sterile.