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.
FDA Recall Z-0557-04 · Posted 2004-02-27
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Recalling FirmScion Cardio-Vascular, Inc.
Recall StatusTerminated
Product CodeFGO
Date Initiated2003-06-30
Date Terminated2004-05-07
Product Quantity41
Reason for Recall
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
Firm 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.
Root Cause
Other
Distribution Pattern
The software systems were installed at 2 medical centers in Illinois and Alabama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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