The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fra
FDA device recall Z-0557-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- Scion Cardio-Vascular, Inc.
- Reason for recall
- The firm received field complaints that it was difficult to open the stone retrieval basket during use.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGO
- Quantity affected
- 41
- Distribution
- The software systems were installed at 2 medical centers in Illinois and Alabama.
- Date initiated
- 2003-06-30
- Date posted
- 2004-02-27
- Date terminated
- 2004-05-07
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563) | Scion Cardiovascular, Inc. | 2000-11-22 |