CardioQuip, LLC Recall 88621
Description: CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
CardioQuip, LLC Recall 88621 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0069-2022 |
| Event ID | 88621 |
| Event Description | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of TX, PA, FL, CA, HI, SC, OH, AK, NY, IL, AR, WI, MI, AL, KS, NJ, GA, AZ, KY, MS, TN, LA, DE, MA, VA, CO, NE, NC, NH, ME, WV, PA, MO, MN, IN, CT, NH, NV, UT and the country of Venezuela. |
| Quantity | 1380 units |
| Recall Reason | There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection. |
| Device Classification | 20211013 |
| Device Code Info | All Serial Numbers |
| Center Classification Date | 20211007 |
| Recall Initiation Date | 20210624 |
| Recalling Firm | CardioQuip, LLC |
| Initial Notification | Letter |
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