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.
This recall has been terminated (originally issued April 8, 2011).
- Company
- Quest Medical, Inc.
- Recall Initiated
- July 29, 2010
- Posted
- April 8, 2011
- Terminated
- April 26, 2011
- Recall Number
- Z-1924-2011
- Quantity
- 771 consoles
- Firm Location
- Allen, TX
- Official Source
- View on FDA website ↗
Reason for Recall
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
Distribution
Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
Lot / Code Info
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
Root Cause
Other
Action Taken
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.