Recall Z-0069-2022 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
CardioQuip, LLC
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
| Date | Jun 24, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 7/30/21, CardioQuip, issued a "Urgent Medical Device Correction" notification to affected consignees. The notification was provided online through CardioQuip's website and mailed letters. In addition to notifying consignees about the recall, the firm requested consignees take the following actions to reduce the risk of patient infection: 1. The optional Airflow Redirection Hood (MCH-10ARH) may be installed onto the Refrigeration Module(MCH-10RMS) as a potential mitigant to aerosolization. This device is attached overtop the Refrigeration Module and directs exhaust downwards, thereby re |
| Quantity | 1380 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 Cardioquip Llp, Nov 19, 2010 |