Device recall
Z-0557-04: The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog #…
FDA device recall · Class II · Scion Cardio-Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0557-04 |
|---|---|
| Recall event | 27452 |
| Product | 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… |
| Product code | FGO |
| Recalling firm | Scion Cardio-Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2004 |
| 510(k) numbers | K001563 |
| FEI number | 1000113395 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database