Recall Z-0554-04 ยท FGO Dislodger, Stone, Flexible
Scion Cardio-Vascular, Inc.
SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
| Date | Feb 27, 2004 (initiated May 23, 2003) |
| Status | Terminated |
| Reason | Possible difficulty for the user in opening the stone retrieval basket. |
| Root cause | Other |
| Action | The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003. |
| Quantity | 28 |
| Distribution | Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001563 | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET Scion Cardiovascular, Inc., Nov 22, 2000 |