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QUEST MEDICAL INC

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: US
Address: —
Website: questmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-627-0226
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 041810693

Catalogue (311)

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Device	Model / Reference	Registries	Class	Status
CleanCut Rotating Aortic Punch, 2.8 mm	RCL28	FDA UDI	Class I	Active
MPS Console Adapter S-7000	5001009	FDA UDI	Class II	Active
CleanCut RCL45 Bulk Nonsterile	RCL45BNS	FDA UDI	Class I	Active
Retract-o-Tape 16g x 45.8cm Heavy Wall_nonsterile	1232	FDA UDI	Class I	Active
MPS 3 Arrest Cartridge	5003104	FDA UDI	Class II	Active
MPS Console Adapter (Century HLM)	5001018	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch, 4.0 mm Nonsterile	RCC40BNS	FDA UDI	Class I	Active
MPS 3 Console Pole Mount	5301023	FDA UDI	Class II	Active
Retract-o-Tape 16g x 30.5cm Thin Wall_nonsterile	1202	FDA UDI	Class I	Active
VRV-II Clear Vacuum Relief Valve - Nonsterile	4004203	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PD05FL	FDA UDI	Class II	Active
MPS Data Output (RS-232) cable	512SCC1	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock Extension	HFSTV03	FDA UDI	Class II	Active
Retract-o-Tape 18g x 30.5cm Blunt Needle	1041	FDA UDI	Class I	Active
Mps	5051103	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCC48	FDA UDI	Class I	Active
CleanCut Rotating Aortic Punch Bulk Nonsterile	RCL50BNS	FDA UDI	Class I	Active
10 in. (25 cm) Q2 Checkmate extension set	9545	FDA UDI	Class II	Active
LacriCATH	DCR508-BIT	FDA UDI	U	Active
Precision Delivery IV Extension Set	PDMV60F	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch, 2.8 mm Nonsterile	RCC28BNS	FDA UDI	Class I	Active
LacriCATH	DCP315-UNIT	FDA UDI	U	Active
MiniGuard Arterial Safety Valve	4008100	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock	STV02	FDA UDI	Class II	Active
MPS 3 Telescoping Mounting Arm	5303008	FDA UDI	Class II	Active
MPS Retrograde Cable	511600R	FDA UDI	Class II	Active
6 in. (15 cm) CheckMate Extension set	9600	FDA UDI	Class II	Active
48 in (122 cm) CheckMate Extension Set	9621	FDA UDI	Class II	Unknown
Q2 Low Pressure Power Injection Extension Set	95714	FDA UDI	Class II	Active
MPS 3 ND Delivery Set w/o AA w/305cm Line (16C)	5ND3100	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDV06	FDA UDI	Class II	Active
MPS 3 ECG Extension Cable	513UEXT	FDA UDI	Class II	Active
CleanCut 5.0 mm Nonsterile Aortic Punch	RCC50BNS	FDA UDI	Class I	Active
MPS Heater Cooler Hose Kit	5001030	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock Extension	HFSTV02	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCL40	FDA UDI	Class I	Active
MPS Console Adapter, base mount	5001025	FDA UDI	Class II	Active
MPS 3 Additive Delivery Line	5053107	FDA UDI	Class II	Active
LacriCATH	DCP315-BIT	FDA UDI	U	Active
115 in (292 cm) Q2 MultiPort IV administration Set, 10 drops/ml	9527B	FDA UDI	Class II	Active
High-Flow 4-Way Stopcock	STV03	FDA UDI	Class II	Active
MPS Console	5001000	FDA UDI	Class II	Active
MPS 3 Drug Pump Cover	5303031	FDA UDI	Class II	Active
MPS 3 Delivery Set w/AA w/106cm (16C)	5163103	FDA UDI	Class II	Active
7 in. (18cm) Q2 T-connector extension set w/ 2 Q2 double checkvalve T-sites, Q2	95704	FDA UDI	Class II	Active
PerfectCut Rotating Aortic Punch, 4.5 mm	RCB45	FDA UDI	Class I	Active
MPS Transducer Holder	5140004	FDA UDI	Class II	Active
MPS 3 ND Delivery Set w/AA w/183 Line (16C)	5ND3102-AS	FDA UDI	Class II	Active
115 in (292 cm) Q2 MultiPort IV administration Set, 60 drops/ml	9526B	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDB05CV1	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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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.