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REMINGTON MEDICAL, INC.

United States·US-MF-000002612

Last updated September 17, 2026

Information

Country: United States
Address: 6830, Meadowridge Court, Alpharetta, United States
Website: remmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)989-0057
PRRC Contact: Dorothy Frieser
EUDAMED SRN: US-MF-000002612
FDA FEI Number: 1000132370
DUNS Number: 788472314

Catalogue (224)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Chiba Needle Marked	CNM-2006NS	FDA UDI	Class I	Active
Chiba Needle Marked	CNM-2203	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-2005	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1816M	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMR-1805NS	FDA UDI	Class II	Active
Disposable Tear-Away Vascular Introducer Set	7008	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-2006NS	FDA UDI	Class II	Active
Westcott Needle Marked	WNM-2206NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-2003NS	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1410	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2207NS	FDA UDI	Class I	Active
Chiba Needle Marked	CNM-2210	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMF-2005NS	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMR-1705	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2208NS	FDA UDI	Class I	Active
Chiba Needle Marked	CNM-2003NS	FDA UDI	Class I	Active
Chiba Needle Marked	CNM-2203NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMR-2006NS	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMR-2003	FDA UDI	Class II	Active
Bag Decanter	9002-NS	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1820	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1820BB	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2206	FDA UDI	Class I	Active
Luer Loc Standard Syringe	LLS-10-Y	FDA UDI	Class II	Active
Automatic Cutting Needle	NAC-1825B	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2008NS	FDA UDI	Class I	Active
Safety Adapter	ADAP II	FDA UDI	Class II	Active
Westcott Needle Marked	WNM-2203NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMR-1705NS	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-1805	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMR-2203NS	FDA UDI	Class II	Active
Guidewire Introducer Needle Square Hub Access Needle	GWI-1802WW-NS	FDA UDI	Class I	Active
Luer Loc Standard Syringe	LLS-10-G	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-1808NS	FDA UDI	Class I	Active
Franseen Needle Marked	FNM-1806	FDA UDI	Class I	Active
Closed Needle Guide	LNGC-2022	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2006	FDA UDI	Class I	Active
Chiba Needle Marked	CNM-2206NS	FDA UDI	Class I	Active
Locking Syringe	LSS-100	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-2003	FDA UDI	Class II	Active
Guidewire Introducer Needle	GWI-1902	FDA UDI	Class I	Active
Luer Loc Standard Syringe	LLS-10-LG	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-2203	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2003	FDA UDI	Class I	Active
Breast Needle Locator	BNL-2010	FDA UDI	Class I	Active
VascuChek Transceiver	VC-TRX-01	FDA UDI	Class II	Active
Chiba Needle Marked	CNM-2210NS	FDA UDI	Class I	Active
Tuohy Epidural Needle	TNMR-1803	FDA UDI	Class II	Active
VascuChek Charger	VC-CH-01	FDA UDI	Class II	Active
Tuohy Epidural Needle	TNMF-1803	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

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

Date	Recall No.	Class	Status	Reason
Nov 3, 2023	Z-0487-2024	—	open, classified	There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
Dec 2, 2022	Z-0771-2023	—	terminated	The stylet is longer than specified on the label
Mar 5, 2014	Z-1441-2014	—	terminated	Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).
Aug 29, 2012	Z-0028-2013	—	terminated	Sterility of the product may be compromised.
Feb 7, 2011	Z-1575-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1573-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1576-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1577-2011	—	terminated	There is a potential for the needle hubs to break during use.
Feb 7, 2011	Z-1574-2011	—	terminated	There is a potential for the needle hubs to break during use.
Jan 12, 2011	Z-2405-2011	—	terminated	There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
May 19, 2010	Z-2223-2010	—	terminated	The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
Jun 19, 2009	Z-1935-2009	—	terminated	Two unsealed pouches were identified after product release, compromising product sterility.
Apr 6, 2009	Z-1417-2009	—	terminated	Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Jul 23, 2007	Z-0058-2008	—	terminated	Sterility, inadequate -- Pathway may not be sterile as labeled.
Jan 19, 2007	Z-0673-2007	—	terminated	Pouches were not sealed prior to sterilization.
Aug 31, 2005	Z-0124-06	—	terminated	The vector selector has an electrical design flaw which prevents RV pacing.
Jun 6, 2005	Z-0067-06	—	terminated	The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
Jun 6, 2005	Z-0066-06	—	terminated	The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
Jun 6, 2005	Z-0065-06	—	terminated	The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
Feb 15, 2005	Z-0697-05	—	terminated	The stylet hub detaches from the stylet needle.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Remington Medical Markham Ontario · CA FEI 3001676837