Recall Z-1924-2011 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quest Medical, Inc
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 surge
| Date | Apr 8, 2011 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. |
| Root cause | Other |
| Action | 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. |
| Quantity | 771 consoles |
| Distribution | Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy |
| FDA record | Open on fda.gov |