Device recall
Z-0903-2009: Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO…
FDA device recall · Class II · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-0903-2009 |
|---|---|
| Recall event | 50512 |
| Product | Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. |
| Product code | OEX |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2009 |
| FEI number | 3007284006 |
At a glance
- None 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