Device recall
Z-0555-2009: EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0555-2009 |
|---|---|
| Recall event | 49510 |
| Product | EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. |
| Product code | NLH |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| 510(k) numbers | K012523, K012678, K043513, K051220 |
| FEI number | 3001237663 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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