Quest Medical, Inc Recalls
FDA
Showing 1-2 of 2 recalls
Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
Quest Medical Incorporated sent a "User Update" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.
Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.