Device recall
Z-0053-2015: ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number…
FDA device recall · Class II · Bio-Detek, Inc.
Key facts
| Recall number (Z-number) | Z-0053-2015 |
|---|---|
| Recall event | 69409 |
| Product | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/… |
| Product code | MKJ |
| Recalling firm | Bio-Detek, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2016 |
| 510(k) numbers | K943698 |
| FEI number | 1218058 |
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