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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2024%22
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