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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0069-2022
Event ID88621
Event DescriptionCardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Product TypeDevices
DistributionWorldwide 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.
Quantity1380 units
Recall ReasonThere 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 Classification20211013
Device Code InfoAll Serial Numbers
Center Classification Date20211007
Recall Initiation Date20210624
Recalling FirmCardioQuip, LLC
Initial Notification Letter
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