Class 2 Device Recall Modular CoolerHeater 1000(i), Refrigeration Module (MCH10RMS)

• Date Initiated by Firm: June 24, 2021
• Create Date: October 07, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0069-2022
• Recall Event ID: 88621
• 510(K)Number: K102147
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: CardioQuip, LLC; 8422 Calibration Ct; College Station TX 77845-5328
• For Additional Information Contact: CardioQuip Customer Service; 979-691-0202
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 redirecting potential aerosols downwards and away from the surgical field. Refer to the MCH Operator/Service Manual R3 2021 for installation instructions. Contact your local CardioQuip representative for assistance purchasing the optional Airflow Redirection Hood for your Refrigeration Module. 2.Ensure all modules and accessories, including the Airflow Redirection Hood and Refrigeration Module,are cleaned and disinfected at the same time as the MCH unit according to the Maintenance section on pg. 47 of the MCH Operator/Service Manual R3 2021. 3.Do NOT move modules or accessories between cooler-heater devices to prevent possible cross-contamination. 4.Please forward this notice to all device users and other parties within and outside your organizationthat need to be aware of this correction. 5. CardioQuip continues to develop a more comprehensive understanding of these risks and determine further action. If you have any questions or concerns regarding the Refrigeration Module (MCH-10RMS), optional Airflow Redirection Hood (MCH-10ARH), or proper device maintenance procedures, please contact CardioQuip via phone or email at: CardioQuip Customer Service: +1 (979) 691-0202 Monday Friday 8 A.M. 5 P.M. CT service@cardioquip.com 6. Receipt and understanding of the corrective action outlined in this letter is required from each CardioQuip customer. Please complete and return the e
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DWC