Class II — CardioQuip, LLC
| Recalling firm | CardioQuip LLC |
|---|---|
| Registered facility | CardioQuip (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| Product | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A |
| Quantity | 4 units |
| Distribution | US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None |
| Initiated | 2023-10-24 |
| Classified | 2023-12-15 |
| Recall number | Z-0565-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CardioQuip, LLC (Z-0565-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93446/
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