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.
- Company
- Scion Cardio-Vascular, Inc.
- Recall Initiated
- June 30, 2003
- Posted
- February 27, 2004
- Terminated
- May 7, 2004
- Recall Number
- Z-0557-04
- Quantity
- 41
- Firm Location
- Miami, FL
Reason for Recall
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
Distribution
The software systems were installed at 2 medical centers in Illinois and Alabama.
Lot / Code Info
Lot Number OML30522-01
Root Cause
Other
Action Taken
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.