FDAFDA · Food and drugs·Recall number Z-0439-2024
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Published December 13, 2023 · Recall initiated: October 19, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CardioQuip, LLC
- Distributor
- US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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