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CardioQuip

Last updated September 17, 2026

Information

Country: US
Address: 8422 Calibration Ct, College Station, TX, 77845
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LinkedIn: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007899424
DUNS Number: —

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
CardioQuip Modular Cooler-Heater (MCH)	MCH-1000(m)	FDA UDI	Class II	Active
CardioQuip Thermoelectric Cooling (TEC) Lid Module	MCH-11TEC	FDA UDI	Class II	Active
VivaCart	Pump Guard Mounting Brackets	FDA UDI	Class I	Active
VivaCart	Side Mount Oxygen Tank Holder (Type E Cylinders)	FDA UDI	Class I	Active
CardioQuip Modular Cooler-Heater (MCH)	MCH-1000(i)	FDA UDI	Class II	Active
VivaCart	Corner Mounting Pole, 25 cm	FDA UDI	Class I	Active
VivaCart	Extended Handle, 16 cm	FDA UDI	Class I	Active
VivaCart	Side Mount Single Hook	FDA UDI	Class I	Active
VivaCart	Corner Mounting Pole, 46 cm	FDA UDI	Class I	Active
VivaCart	Removable Upper Shelf	FDA UDI	Class I	Active
VivaCart	Compact Handle, 4cm	FDA UDI	Class I	Active
CardioQuip Refrigeration Module	MCH-10RMS	FDA UDI	Class II	Active
VivaCart	Storage Basket	FDA UDI	Class I	Active
VivaCart	Infusion Pole Kit	FDA UDI	Class I	Active
VivaCart	Weight Plate Kit	FDA UDI	Class I	Active
VivaCart	VC-1000	FDA UDI	Class I	Active
VivaCart	Side Mount Triple Hook	FDA UDI	Class I	Active
VivaCart	Side Mount Power Strip, 20A	FDA UDI	Class I	Active

Related Companies

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FDA Recalls (9)

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
Oct 24, 2023	Z-0566-2024	—	open, classified	There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Oct 24, 2023	Z-0565-2024	—	open, classified	There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Oct 19, 2023	Z-0439-2024	—	open, classified	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Oct 19, 2023	Z-0438-2024	—	open, classified	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Jun 24, 2021	Z-0069-2022	—	open, classified	There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
May 12, 2021	Z-0035-2022	—	open, classified	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
May 12, 2021	Z-0038-2022	—	open, classified	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
May 12, 2021	Z-0037-2022	—	open, classified	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
May 12, 2021	Z-0036-2022	—	open, classified	Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.