FDA Device recall Z-0439-2024
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A by Cardioquip, citing there is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0439-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardioquip |
| Distribution | AL, CA, CT, FL, IA, IL, IN, KY, NJ, PA, TX, VA, WA, WI, WV |
Product
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Reason
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Identifiers
| code_info | UDI: (01)00860000846103/ Serial Numbers: Serial Numbers: 10160461, 10160463, 10160465, 10160466, 101060467, 10160468, 1…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, 10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Cardioquip
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip - CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip - CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
FDA Device · Class II · 2023-12-13 · Cardioquip - CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
FDA Device · Class II · 2021-10-13 · Cardioquip - CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Device · Class II · 2021-10-13 · Cardioquip
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2024%22
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