Device Recall MPS and MPS 2 Consoles

  • Model / Serial
    MPS Serial Numbers: 2022, 2023, 2024, 2297, 2307, 2177, 2258, 2259, 2261, 2263, 2266, 2421, 2422, 1198, 1379, 1385, 1395, 2022, 2023, 2024, 2335, 2336, 2396, 9069, 1407, 1408, 1409, and 2078
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Quest Medical, Inc, 1 Allentown Pkwy, Allen TX 75002-4206
  • Manufacturer Parent Company (2017)
  • Source
    USFDA