FDA Device recall Z-0565-2024
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 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 the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0565-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-24 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardioquip |
| Distribution | CA, NE, OH, PA, TX, WA |
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Reason
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Identifiers
| code_info | UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040 |
|---|
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-0565-2024%22
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