Class 2 Device Recall CardioQuip, Modular CoolerHeater, Model: MCH1000m

• Date Initiated by Firm: May 12, 2021
• Date Posted: October 06, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0037-2022
• Recall Event ID: 88622
• 510(K)Number: K102147
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
• 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: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
• FDA Determined Cause: Error in labeling
• Action: On 7/30/21, CardioQuip issued a "Urgent Medical Device Correction" notification to all affected consignees. The communication was provided via US Mail, E-Mail and firm's website. In addition, to informing consignees about the correction, CardioQuipe ask consignees to take the following actions: 1.Replace copies of the current MCH Operators/Service Manual R2 2016 with the updated version MCHOperators/Service Manual R3 2021 provided as of July 30, 2021 on our website: http://www.CardioQuip.com/resources. This new version includes revisions that reflect the content in this letter. 2.Only use sterile or 0.22-micron-filtered water. Do not use tap water to rinse, fill, refill, or top-off watertanks, as this may introduce microorganisms into the water path. 3.When making ice needed for patient cooling during surgical procedures, use only sterile or 0.22-micron-filtered water. 4. Strictly adhere to the maintenance activities of cleaning and disinfection found on pg. 47-51 of the newMCH Operator/Service Manual R3 2021. 5.Schedule annual preventive maintenance by an authorized CardioQuip technician as outlined on pg.51 of the new MCH Operator/Service Manual R3 2021. 6.Clean and disinfect all accessories connected to the cooler-heater according to the respective manufacturer s instructions for use. Device contamination can occur from sources such as environmental contamination or device contact with contaminated accessories. 7.Ensure all modules and accessories, including the Refrigeration Module and TEC lid, are cleaned and disinfected at the same time as the MCH unit according to the Maintenance section of the new MCH Operator/Service Manual R3 2021. 8.Do NOT move modules or accessories between cooler-heater devices to prevent possible cross-contamination. 9.Immediately remove from service devices that show signs of contamination in the tank or water path, such as cloudiness or discoloration. Contact CardioQuip Customer Service to receive assistance with contamina
• Quantity in Commerce: 1646 units
• 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.
• 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 and Original Applicant = CARDIOQUIP LLP