Device recall
Z-0336-2010: Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0336-2010 |
|---|---|
| Recall event | 53704 |
| Product | Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Material Number (OUTER CARTON LABEL… |
| Product code | DQO |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2011 |
| 510(k) numbers | K050863 |
| 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