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U.S. Department of Health and Human Services

Class 2 Device Recall CardioQuip Modular CoolerHeater

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  Class 2 Device Recall CardioQuip Modular CoolerHeater see related information
Date Initiated by Firm October 19, 2023
Date Posted December 01, 2023
Recall Status1 Open3, 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
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 2		 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 and Original Applicant = CARDIOQUIP LLP
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