FDA Recall
Terminated
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.
Recall: Z-0557-04
·
Initiated June 30, 2003
Recall
- Recall Number
- Z-0557-04
- Event Number
- 27452
- Firm
- Scion Cardio-Vascular, Inc.
- FEI Number
- 1000113395
- Product Code
- FGO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 30, 2003
- Posted
- February 27, 2004
- Terminated
- May 7, 2004
- Address
- 14256 SW 119 Avenue, Miami, FL, 33186
Description
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.
Reason
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
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.
Distribution
The software systems were installed at 2 medical centers in Illinois and Alabama.
Quantity
41