Company: Quest Medical Inc.
Date of Enforcement Report 4/20/2011
Class lll:

PRODUCT
Quest MPS and MPS 2 Consoles. 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. Recall # Z-1924-2011

REASON
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

RECALLING FIRM/MANUFACTURER
Quest Medical, Inc., Allen, TX, by letter in July 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
771 consoles

DISTRIBUTION
Nationwide and Internationally