Device recall
Z-1393-2012: Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1393-2012 |
|---|---|
| Recall event | 61505 |
| Product | Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001… |
| Product code | KOD |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2014 |
| 510(k) numbers | K011965, K102527 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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