19
May
2011

Cl lll Quest MPS and MPS 2 Consoles

0

Company:Quest Medical, Inc.
Date of Enforcement Report 5/18/2011
Class lll:

PRODUCT
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. 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 units

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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