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Terminated

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.

FDA Recall Z-1924-2011 · Posted 2011-04-08

Recalling FirmQuest Medical, Inc
Recall StatusTerminated
Product CodeDTR
Date Initiated2010-07-29
Date Terminated2011-04-26
Product Quantity771 consoles

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041979MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260Quest Medical, Inc. · 2004-09-02K953838MYOCARDIAL PROTECTION SYSTEMQuest Medical, Inc. · 1996-03-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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