Field Corrective Action

 CardioQuip requires receipt of all Field Corrective Action notices and customer communication letters per FDA 21 CFR Part 7.49(c)(1)(5) to ensure safe use of all CardioQuip devices.

July 2021 Recall

30 July 2021
Customer Letter: URGENT MEDICAL DEVICE CORRECTION MCH-1000 COOLER HEATER

• Customer Letter—This recall provides a labeling update for the MCH Operator’s/Service Manual with additional guidance for proper MCH-1000 water-quality maintenance and device inspection. 

• FAQ for Customer Letter —Common questions answered regarding this recall

• Customer Acknowledgment of Receipt —Link to online acknowledgment form

30 July 2021
Customer Letter: MCH-1000(i) REFRIGERATION MODULE (MCH-10RMS) URGENT MEDICAL DEVICE CORRECTION

• Customer Letter—This correction identifies the Airflow Redirection Hood as a possible risk mitigation component for patient infection.

• FAQ for Customer Letter —Common questions answered regarding this correction

• Customer Acknowledgment of Receipt —Link to online acknowledgment form

Customer Acknowledgment of Receipt:

Please click below to acknowledge receipt of letter(s).