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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 24, 2023
Date Posted December 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-0565-2024
Recall Event ID 93446
510(K)Number K102147  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Code Information UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
Recalling Firm/
Manufacturer		 CardioQuip, LLC
8422 Calibration Ct
College Station TX 77845-5328
For Additional Information Contact Charley Ford
979-691-0202
Manufacturer Reason
for Recall		 There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA Determined
Cause 2		 Process control
Action On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:
Quantity in Commerce 4 units
Distribution US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
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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