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U.S. Department of Health and Human Services

Class 2 Device Recall SCIPRO

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  Class 2 Device Recall SCIPRO see related information
Date Initiated by Firm June 30, 2003
Date Posted February 27, 2004
Recall Status1 Terminated 3 on May 07, 2004
Recall Number Z-0557-04
Recall Event ID 27452
510(K)Number K001563  
Product Classification Dislodger, Stone, Flexible - Product Code FGO
Product The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.
Code Information Lot Number OML30522-01
Recalling Firm/
Manufacturer		 Scion Cardio-Vascular, Inc.
14256 SW 119 Avenue
Miami FL 33186
For Additional Information Contact Ramon Augusto Paz
305-259-8880 Ext. 107
Manufacturer Reason
for Recall		 The firm received field complaints that it was difficult to open the stone retrieval basket during use.
FDA Determined
Cause 2		 Other
Action The firm mailed a recall letter to there consignees on June 30, 2003 requesting return of any unused devices. The firm has received 100% response and accounted for all recalled devices.
Quantity in Commerce 41
Distribution The software systems were installed at 2 medical centers in Illinois and Alabama.
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 = FGO and Original Applicant = SCION CARDIOVASCULAR, INC.
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