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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
Precision Delivery IV Extension Set	PD60	FDA UDI	Class II	Active
RLV-2100 "B" Vacuum Relief Valve	4103102	FDA UDI	Class II	Active
Delivery Set 16C w/ AA 183cm Line	5161102-AS	FDA UDI	Class II	Active
MPS Stand Alone Cart	5001005	FDA UDI	Class II	Active
Q2 5ft/1.5m IV Ext Set	95727	FDA UDI	Class II	Active
Q2 Multiport Extension Set	95712	FDA UDI	Class II	Active
MPS Console Pole Mount Adapter	5001023	FDA UDI	Class II	Active
25ft/7.6m IV Ext Set w/ Sleeve	95725	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCC50	FDA UDI	Class I	Active
Retract-o-Tape	1241	FDA UDI	Class I	Active
MPS Water Hose Connector Kit	801221	FDA UDI	Class II	Active
Q2 Extension Set 17 in (43.2 cm)	95902	FDA UDI	Class II	Active
CleanCut 4.8 mm Nonsterile Aortic Punch	RCC48BNS	FDA UDI	Class I	Active
Checkmate IV Administration Set 123in (312 cm)	9652	FDA UDI	Class II	Unknown
PerfectCut Aortotomy System	RCK45	FDA UDI	Class I	Active
MPS 3 Controller	5303000	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDV06F	FDA UDI	Class II	Active
Retract-o-Tape 18g x 35.6cm Thin Wall w Needle_non sterile	1291	FDA UDI	Class I	Active
Precision Delivery IV Extension Set, Amber	PDTV05A	FDA UDI	Class II	Active
Exoflex 9in. T-Extension Set	95770	FDA UDI	Class II	Active
Exoflex 9in. T-Extension Set	95778	FDA UDI	Class II	Active
LacriCATH	DCP213-UNIT	FDA UDI	U	Active
CleanCut Rotating Aortic Punch Bulk Nonsterile	RCL40BNS	FDA UDI	Class I	Active
Exoflex 10.5in. T-Extension Set	95782	FDA UDI	Class II	Active
RetroGuard Arterial Safety Valve	4007100	FDA UDI	Class II	Active
MPS 3 Delivery Set w/183cm (16C)	5163100	FDA UDI	Class II	Active
Precision Delivery IV Extension Set, Amber	PDV60FA	FDA UDI	Class II	Active
Retract-o-Tape 18g x 30.5cm Thin Wall	1001	FDA UDI	Class I	Active
Precision Delivery IV Extension Set	PDB05CV2	FDA UDI	Class II	Active
MPS Hypothermic Reservoir Hoses	5001003	FDA UDI	Class II	Active
Delivery Set 16C w/ AA 35cm Line	5161102	FDA UDI	Class II	Active
Precision Delivery IV Extension Set, Amber	PDV06A	FDA UDI	Class II	Active
MPS® Extension Tubing, 6 ft. x 3/16 in.	7001103	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV60125	FDA UDI	Class II	Active
18 in (46 cm) Q2 Extension set w/ standard bore tubing	9546	FDA UDI	Class II	Unknown
CleanCut Rotating Aortic Punch Bulk Nonsterile	RCL48BNS	FDA UDI	Class I	Active
MPS Back Up System, side crank	5001017	FDA UDI	Class II	Active
RLV-2100"B" Vacuum Relief Valve	4103202	FDA UDI	Class II	Active
MPS Hypothermic Reservoir Holder	5001002	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCL35	FDA UDI	Class I	Active
CleanCut Rotating Aortic Punch, 2.8 mm	RCC28	FDA UDI	Class I	Active
Mps	5001106	FDA UDI	Class II	Active
Mps	5001108	FDA UDI	Class II	Active
STENTube Lacrimal Intubation Set	LIS052	FDA UDI	U	Active
Q2® Needleless injection site	3150	FDA UDI	Class II	Active
25ft/7.6m IV Extension Set	95724	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch, 3.5 mm	RCC35	FDA UDI	Class I	Active
High-Flow 4-Way Stopcock	ST01	FDA UDI	Class II	Active
Exoflex 55in. T-Extension Set	95788	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDV60F	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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.