CardioQuip, LLC and Wickimed Medical Equipment Manufacturing Co., Ltd. Receive U.S. FDA Warning Letters

The U.S. Food & Drug Administration has issued warning letters to CardioQuip, LLC for its Modular Cooler Heater Model MCH-1000 and to Wickimed Medical Equipment Manufacturing Co., Ltd., (Wickimed) for its Sterile Single Use Disposable Electrodes.

The warning letter to CardioQuip requested the company stop commercial distribution of those Modular Cooler-Heater (MCH) add on modules that the company has made significant changes to that makes them misbranded and adulterated. The FDA has concluded that these changes could notably affect the safety and efficiency of the device.

The same company was also cited by the FDA for not taking corrective and preventive action related to an increase in complaints of device contamination with nontuberculosis mycobacteria (NTM). The FDA had previously warned health care providers of the potential risk of NTM infection during cardiac surgery with CardioQuip’s MCH device and has issued safety communications about the risk of NTM with heater-cooler devices. CardioQuip has acknowledged the device was linked to infection but has yet to link the device to patient infection.

A second company, the China based Wickimed, received an FDA warning letter after its Class II Sterile Single Use Disposable Electrodes were found to be adulterated after it was discovered that the facility failed to meet current good manufacturing practice requirements, failed to validate its sterilization procedures, and failed to maintain adequate procedures to control the design of the device, document control procedures, and device history records.

Did you or someone you know purchase one of these devices? If so, please contact us immediately to discuss your legal options. The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully prosecuted numerous consumer protection actions and we look forward to discussing this matter with you.