CardioQuip, LLC Recall 88622
Description: CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
CardioQuip, LLC Recall 88622 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0035-2022 |
| Event ID | 88622 |
| Event Description | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 |
| Product Type | Devices |
| 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. |
| Quantity | 1478 units |
| Recall Reason | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| Device Classification | 20211013 |
| Device Code Info | All Serial numbers |
| Center Classification Date | 20211006 |
| Recall Initiation Date | 20210512 |
| Recalling Firm | CardioQuip, LLC |
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