FDA Device recall Z-0035-2022
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 by Cardioquip, citing labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0035-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-12 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardioquip |
| Distribution | US |
Product
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Reason
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Identifiers
| code_info | All Serial numbers |
|---|
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-0035-2022%22
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