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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
PerfectCut Rotating Aortic Punch	RCB48	FDA UDI	Class I	Active
MPS 3 Mini Prime Delivery Set w/AA w/o Line	7003102	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV103Y	FDA UDI	Class II	Active
Q2 Flexible IV Extension Set, 3 port	95713	FDA UDI	Class II	Active
MPS 3 ND Console	5301000ND	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDFL	FDA UDI	Class II	Active
Retract-o-Tape 10g x 45.8cm Thin Wall	1015	FDA UDI	Class I	Active
MPS2 Console	5202450	FDA UDI	Class II	Active
MPS 3 Pole Mount Plate	5301027	FDA UDI	Class II	Active
SaddleLoop 18g x 10cm with Blunt Needle	1541	FDA UDI	Class I	Active
MPS Console Adapter (S-8000 HLM)	5001011	FDA UDI	Class II	Active
Q2 High Flow Extension Set	HFSTV01	FDA UDI	Class II	Active
Q2 Low Pressure Power Injection Extension Set	95906	FDA UDI	Class II	Active
10 in (25 cm) Q2 T connector extension set w/ 3 Q2 checkvalve T-sites	95702	FDA UDI	Class II	Active
Lacrimal Intubation Set, Crawford Type	LIS27T	FDA UDI	U	Active
Exoflex 10.5in. IVExtension Set	95781	FDA UDI	Class II	Active
MPS Console Adapter (SIII HLM)	5001013	FDA UDI	Class II	Active
8.5 in (22 cm) 3 Double T-site IV Extension Set	95711	FDA UDI	Class II	Active
MPS 3 Medical Air Hose Kit	5303010	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV10125	FDA UDI	Class II	Active
MPS 3 RS232 Cable	513USCC	FDA UDI	Class II	Active
MPS 3 ND Delivery Set w/AA w/305cm Line (16C)	5ND3102	FDA UDI	Class II	Active
Q2 Multiport Extension Set	9520S	FDA UDI	Class II	Active
MPS Hypothermic Reservoir	5001001	FDA UDI	Class II	Active
PerfectCut Aortotomy System	RCK40	FDA UDI	Class I	Active
Q2 Low Pressure Power Injection Extension Set w/Swab	95907	FDA UDI	Class II	Active
MPS 3 Blood Bypass Tubing	5301016	FDA UDI	Class II	Active
MPS 3 Articulating Mounting Arm	5303007	FDA UDI	Class II	Active
MPS Power Cord, North America	520NA16	FDA UDI	Class II	Active
MPS 3 Power cord	530NA16	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV102Y	FDA UDI	Class II	Active
MPS Antegrade Cable	511600A	FDA UDI	Class II	Active
Q2 Blood Administration Sets	Y115	FDA UDI	Class II	Active
12.5 in (32 cm) Q2 T-extension set w/ 3 Q2 checkvalve T-sites, in-line checkvalv	95710	FDA UDI	Class II	Active
MPS 3 USB UDMS Cable	513UDMS	FDA UDI	Class II	Active
Q2 Blood Administration Set	YV130	FDA UDI	Class II	Active
MPS 3 ECG Splitter	513USPT	FDA UDI	Class II	Active
6" (15 cm) Microbore Extension Set with Clamp	9065	FDA UDI	Class II	Active
PerfectCut Aortotomy System	RCK48	FDA UDI	Class I	Active
Q2 Multiport Extension Set	9520	FDA UDI	Class II	Active
Q2 High Flow Stopcock, BNS	STV01BNS	FDA UDI	Class II	Active
Q2 Checkmate Extension Set	9543	FDA UDI	Class II	Active
MPS 3 Arrest Agent Delivery Line	5053106	FDA UDI	Class II	Active
Lyka® PORT Needle Free Access Device	4170Y	FDA UDI	Class II	Active
Retract-o-TapeRetract-o-Tape 16g x 45.8cm Thin Wall	1012	FDA UDI	Class I	Active
Precision Delivery IV Extension Set	PDM60F	FDA UDI	Class II	Active
MPS 3 Delivery Set w/AA w/305cm Line (16C)	5163102	FDA UDI	Class II	Active
Precision Delivery Trifurcated IV Extension Set	PDT05	FDA UDI	Class II	Active
11.25 in Exoflex IV Ext Set	95786	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDT05CV2	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.