Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Quest Myocardial Protection System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Quest Myocardial Protection System see related information
Date Initiated by Firm May 23, 2003
Date Posted July 22, 2003
Recall Status1 Terminated 3 on February 18, 2004
Recall Number Z-1037-03
Recall Event ID 26429
510(K)Number K953838  
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Quest 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
Action The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
Quantity in Commerce 2158 devices
Distribution CA, 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 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 = DWF and Original Applicant = QUEST MEDICAL, INC.
-
-