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QUEST MEDICAL INC

United States·US-MF-000008538

Last updated May 24, 2026

What QUEST MEDICAL INC makes

Quest Medical Inc manufactures intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. The company also produces single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

The company is based in the United States, and its product portfolio includes devices categorized as Class I, Class II, and Class U. These devices are listed in the FDA 510(k) and FDA UDI databases.

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

Frequently asked questions

Where is Quest Medical Inc based?

Quest Medical Inc is based in the United States. This information is provided to clarify the company's geographical origin and operational base as stated in the official device data.

What types of medical devices does Quest Medical Inc manufacture?

The company manufactures a diverse range of medical equipment, including intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. Additionally, they produce single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

How are the devices from Quest Medical Inc classified?

The devices produced by Quest Medical Inc are classified as Class I, Class II, and Class U. These classifications are assigned based on the regulatory framework governing the specific medical devices within the company's portfolio.

Which regulatory registries list the devices produced by Quest Medical Inc?

The devices manufactured by Quest Medical Inc are listed in the FDA 510(k) and FDA UDI databases. These registries are used to track and document the regulatory status and identification of the medical devices produced by the company.

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

Information

Country: United States
Address: One Allentown Parkway, Allen, United States
Website: www.questmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800-627-0226
PRRC Contact: Jan Hodges
EUDAMED SRN: US-MF-000008538
FDA FEI Number: —
DUNS Number: 041810693

Catalogue (311)

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Device	Model / Reference	Registries	Class	Status
MPS® Mini-Prime Delivery Set	7001101	FDA UDI	Class II	Active
Mps	5051102	FDA UDI	Class II	Active
VRV-II Vacuum Relief Valve	4003103	FDA UDI	Class II	Active
44 in (112 cm) CheckMate Extension set	9620	FDA UDI	Class II	Unknown
MPS 3 Additive Cartridge	5003105	FDA UDI	Class II	Active
MPS Hypothermic Reservoir	5001001G	FDA UDI	Class II	Active
MPS Console Adapter (Jostra)	5001019	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock Extension	HFST01	FDA UDI	Class II	Active
16 in Exoflex IV Ext Set	95791	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch, 3.5 mm Nonsterile	RCC35BNS	FDA UDI	Class I	Active
CleanCut Rotating Aortic Punch, 4.5 mm	RCC45	FDA UDI	Class I	Active
Q2 Blood Administration Set	YV115	FDA UDI	Class II	Active
LacriCATH	DCR508-UNIT	FDA UDI	U	Active
6 in (15 cm) Q2 T-connector extension set, 2 Q2 T-sites without checkvalves, in-	95707	FDA UDI	Class II	Active
Qlinch Securement Band	QSB0060	FDA UDI	Class I	Active
10 in (25 cm) CheckMate Extension set	9622	FDA UDI	Class II	Unknown
Aortotomy System Lancet 3.3mm	ALX33	FDA UDI	Class I	Active
Exoflex 53in. T-Extension Set	95779	FDA UDI	Class II	Active
STENTube	LIS052	FDA UDI	U	Active
MPS 3 Console	5301000	FDA UDI	Class II	Active
PerfectCut Aortotomy System	RCK50	FDA UDI	Class I	Active
MPS 3 ISO Medical Air Hose Kit	5303010-CA	FDA UDI	Class II	Active
Mps	5001105	FDA UDI	Class II	Active
42 in(107cm) Extension Set w/ 2 check valves	9219	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock	ST02	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDM60	FDA UDI	Class II	Active
Q2 Vial Adapter, 20 mm	3160	FDA UDI	Class II	Active
MPS® Low Volume Delivery Set	7001102	FDA UDI	Class II	Active
MPS 3 Delivery Set w/AA w/106cm (10C)	5003103	FDA UDI	Class II	Active
Precision Delivery IV Extension Set, Amber	PDTV05DFA	FDA UDI	Class II	Active
Mps	5001111	FDA UDI	Class II	Active
Precision Delivery Trifurcated IV Extension Set	PDT05F	FDA UDI	Class II	Active
MPS 3 Delivery Set w/183cm (10C)	5003100	FDA UDI	Class II	Active
SaddleLoop 18g x 10cm with Semi-pointed Needle	1571	FDA UDI	Class I	Active
75inch Vented IV administration Set	22-201V	FDA UDI	Class II	Active
LacriCATH	LDC213T	EUDAMEDFDA UDI	U	Active
MPS Back Up System, side crank	5001015	FDA UDI	Class II	Active
Coronary Sinus Transducer Interface Cable (Retrograde)	511800R	FDA UDI	Class II	Active
MPS 3 Delivery Set w/AA w/183 Line (16C)	5163102-AS	FDA UDI	Class II	Active
CleanCut 4.5 mm Nonsterile Bullet Aortic Punch	RCB45BNS	FDA UDI	Class I	Active
7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub	95701	EUDAMEDFDA UDI	Class II	Active
Retract-o-Tape 16g x 30.5cm Thin Wall	1002	FDA UDI	Class I	Active
Retract-o-Tape 18g x 30.5cm Thin Wall_nonsterile	1201	FDA UDI	Class I	Active
Mps	5001104	FDA UDI	Class II	Active
PerfectCut Rotating Aortic Punch	RCB40	FDA UDI	Class I	Active
CleanCut Rotating Aortic Punch, 3.5 mm Nonsterile	RCL35BNS	FDA UDI	Class I	Active
LacriCATH	LDC315T	FDA UDI	U	Active
CleanCut Rotating Aortic Punch, 4.5 mm	RCL45	FDA UDI	Class I	Active
MiniGuard Arterial Safety Valve, Non-Sterile	4008200	FDA UDI	Class II	Active
MPS Delivery Set	5001100	FDA UDI	Class II	Active

Related Companies

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Authorities

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FDA Recalls (7)

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

Quest Medical Inc has seven recall records, with the earliest initiated on 2003-05-23 and the most recent on 2023-07-14. The recorded statuses include open, classified, and terminated. The reasons listed for the recalls involve swapped and incorrectly placed additive and arrest agent labels on a heat exchanger kit, potential tubing detachment in delivery sets, an incorrectly printed expiration date on pouch and carton labels, a user update concerning installation of external heater‑cooler units, intermittent seal failure during use, and cassette leaks that could delay administration of cardioplegia solutions.

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
Jul 14, 2023	Z-0197-2024	—	open, classified	For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Dec 23, 2022	Z-1100-2023	—	open, classified	Delivery Sets may have tubing that could become detached that could result in patient infection.
Dec 17, 2019	Z-2107-2020	—	terminated	Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
Oct 28, 2015	Z-0361-2016	—	terminated	The products have been found to intermittently exhibit a seal failure during use.
Feb 26, 2015	Z-1368-2015	—	terminated	Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Jul 29, 2010	Z-1924-2011	—	terminated	User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
May 23, 2003	Z-1037-03	—	terminated	Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.