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Recall Observatory FDA recall evidence

Device product

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

Z-0439-2024

October 19, 2023

Class II

Product summary

Firm
CardioQuip, LLC
Event
Event 93347
Status
Ongoing
Classification
Class II
Quantity
125 units
Official record key
device-enforcement:Z-0439-2024

Official wording

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

Code information: 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

Distribution pattern: US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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