Device recall
Z-1011-2012: Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number…
FDA device recall · Class II · Bio-Detek, Inc.
Key facts
| Recall number (Z-number) | Z-1011-2012 |
|---|---|
| Recall event | 60835 |
| Product | Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. |
| Recalling firm | Bio-Detek, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2012 |
| 510(k) numbers | K072430 |
| FEI number | 1218058 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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