Class II — CardioQuip, LLC
| Recalling firm | CardioQuip LLC |
|---|---|
| Registered facility | CardioQuip (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| Product | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110 |
| Quantity | 1646 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay. |
| Initiated | 2021-05-12 |
| Classified | 2021-10-06 |
| Recall number | Z-0037-2022 |
| 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-0037-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88622/
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