Class 2 Device Recall CardioQuip Modular CoolerHeater

• Date Initiated by Firm: October 19, 2023
• Date Posted: December 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0438-2024
• Recall Event ID: 93347
• 510(K)Number: K102147
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
• Code Information: UDI: (01)00860000846110/Serial Numbers: 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, 11160320, 11161109, 11161832, 11161836, 11161837, 11161838, 11161839, 11160216, 11160217, 11160218, 11160548, 11160549, 11160550, 11160103, 11160338, 11160339, 11160364, 11160365, 11160366, 11161117, 11161118, 11161827,11161828, 11161829, 11161942, 11161943, 11161944, 11161978, 11162016, 11162018, 11160461, 11160462, 11160463, 11160464, 11160465, 11160579, 11161487, 11161488, 11161489, 11161613, 11161692, 11161695, 11161701, 11161702, 11161696 11161627, 11162262, 11160298, 11160378, 11160380, 11160385, 11160386, 11160387, 11160388, 11160377, 11160379, 11160376, 11160439, 11160440, 11161458, 11161460, 11161815, 11161816, 11161817, 11161818, 11161819, 11161907, 11161916, 11162057, 11162078, 11162079, 11162080, 11160375, 11160083, 11160270, 11160271, 11161018, 11161024, 11161019, 11161023, 11161022, 11161020, 11161021, 11160553, 11160554, 11161143, 11161144, 11161147, 11162002, 11162008, 11162009, 11162010, 11162011, 11160277, 11160290, 11160391, 11160289, 11161667, 11161668, 11161669, 11161670, 11161972, 11161973, 11161294, 11162139, 11162141, 11162142, 11162143, 11162170, 11162171 11160031, 11161076, 11161077, 11161890, 11162128, 11162129, 11161187, 11161189, 11161193, 11161194, 11161545, 11161546, 11161547, 11161549, 11160024, 11160025, 11160027, 11160075, 11161126, 11160314, 11162053, 11162054 11160071 11161083, 11161084, 11161085, 11161086, 11161087, 11161088, 11161089, 11161090, 11161091, 11161092
• FEI Number: 3007899424
• Recalling Firm/ Manufacturer: CardioQuip, LLC; 8422 Calibration Ct; College Station TX 77845-5328
• For Additional Information Contact: CardioQuip Customer Service; 888-267-6700
• Manufacturer Reason for Recall: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
• FDA Determined Cause: Device Design
• Action: On 10/19/23, CardioQuip issued a "Urgent: Medical Device Correction" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication. CardioQuip ask consignees to take the following actions: 1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use. 2.Never operate the device dry (see communication for further details). 3. Design Changes to be implemented (see communication for further details). A. Relocation of the water Level Sensor (see communication for further details). B. Software Update (see communication for further details). 4. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. 5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm
• Quantity in Commerce: 150 units
• Distribution: US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
• 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