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U.S. Department of Health and Human Services

Class 3 Device Recall MPS and MPS 2 Consoles

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  Class 3 Device Recall MPS and MPS 2 Consoles see related information
Date Initiated by Firm July 29, 2010
Date Posted April 08, 2011
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-1924-2011
Recall Event ID 57141
510(K)Number K041979  K953838  
Product Classification Heat-exchanger, cardiopulmonary bypass. - Product Code DTR
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.
Code Information 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
Recalling Firm/
Manufacturer		 Quest Medical, Inc
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information Contact
972-390-9800
Manufacturer Reason
for Recall		 User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 771 consoles
Distribution Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTR and Original Applicant = QUEST MEDICAL, INC.
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