Device recall
Z-0264-2012: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0264-2012 |
|---|---|
| Recall event | 60365 |
| Product | Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA… |
| Product code | DRE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2013 |
| 510(k) numbers | K052557 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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