FDAClass IIDecember 13, 2023

CardioQuip Modular Cooler-Heater recall

CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

Why was CardioQuip Modular Cooler-Heater recalled?

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: (01)00860000846103/ Serial Numbers: Serial Numbers: 10160461, 10160463, 10160465, 10160466, 101060467, 10160468, 10161406, 10161408, 10161553, 10161689, 10160275 1016276, 1016277, 10160274, 10161065, 10161066, 10160825, 10160826, 10160827, 10160828, 10161140, 10161141, 10160830, 10160831, 10160832, 10160833, 10161543, 10160449, 10160450, 10160451, 10160452 , 1016050512, 10160513, 10160781, 10160785, 10160786, 10160787, 10160788, 10160789, 10160790, 10160791, 10160792, 10160793, 10160794, 10160795, 10161130, 10161131, 10161329, 10161517, 10160758, 10160094, 10160095, 10160096, 10160110, 10160113, 10160114, 10161294, 10161301, 10161303, 10161304, 10161306, 10160570, 10160572, 10160623 ,10160797, 10160798, 10160279, 10160280, 10160281, 10160282, 10161021, 10160797, 10161199, 10161200, 10161275, 10161343, 10161344, 10161560, 10161561, 10160824, 10160767, 10160097, 10160098, 10160099, 10160104, 10160105, 10160106, 10160108, 10160109, 10161043, 10161187, 10161679, 10161680, 10161681, 10160983, 10161830, 10160517, 10160519, 10160520, 10161312, 10160190, 10160191, 10160192, 10160193, 10160194, 10160248, 10160249, 10160250, 10160251, 10160967, 10160683, 10160684, 10160685, 10160686, 10160687, 10160688, 10160689, 10160690, 10161358, 10161359, 10161362, 10160084, 10160161, 10160183, 10161841

Product
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Recalling firm
CardioQuip, LLC
Quantity
125 units
Distribution
US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
Recall date
December 13, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls