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U.S. Department of Health and Human Services

Class 2 Device Recall Quest Myocardial Protection System

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 Class 2 Device Recall Quest Myocardial Protection Systemsee related information
Date Initiated by FirmMay 23, 2003
Date PostedJuly 22, 2003
Recall Status1 Terminated 3 on February 18, 2004
Recall NumberZ-1037-03
Recall Event ID 26429
510(K)NumberK953838 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductQuest Myocardial Protection System (MPS) Arrest/Additive Cassettes
Code Information Catalog Number: 5001102 Lot numbers; 20823.R10; 20853.S01; and 20863.S04  Catalog Number 5001104, lot number 20706.S09  Lots manufactured but not distributed: Catalog Number 6001101, lot 20639.R10  Catalog Number 7001102, lot 20638.R10
Recalling Firm/
Manufacturer		 Quest Medical, Inc
One Allentown Pkwy
Allen TX 75002
Manufacturer Reason
for Recall		Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
FDA Determined
Cause 2		Other
ActionThe firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
Quantity in Commerce2158 devices
DistributionCA, PA, FL, ME, TX, MA, OH, ON, NM, WA, MO, GA, SC, MS, IL, LA, NC, NJ, MA, AK, TN, MT, WI, IN, WV, NE, Japan, Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWF
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