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U.S. Department of Health and Human Services

Class 2 Device Recall MPS Delivery Set

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  Class 2 Device Recall MPS Delivery Set see related information
Date Initiated by Firm October 28, 2015
Date Posted December 02, 2015
Recall Status1 Terminated 3 on November 17, 2016
Recall Number Z-0361-2016
Recall Event ID 72524
510(K)Number K953838  
Product Classification Heat-exchanger, cardiopulmonary bypass - Product Code DTR
Product Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
Code Information 0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04,  0493675U04, 0493685U07, 494465U07, 0494475U09, 0494855G01, 0495215U11, 0495225U11, 0495505G02, 495515G02, 0496535G08, 0496875G08, 496885G08, 0497245S02, 0495205U11, 497255S04, 0497655S04, 0498535S06, 0498545S06, 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02, 0495965G04, 0492765E07
Recalling Firm/
Manufacturer		 Quest Medical, Inc.
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information Contact Amy Clendening-Wheeler
972-390-9800
Manufacturer Reason
for Recall		 The products have been found to intermittently exhibit a seal failure during use.
FDA Determined
Cause 2		 Equipment maintenance
Action The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.
Quantity in Commerce 18,761 units
Distribution Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, 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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