Device recall
Z-0977-2018: OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214…
FDA device recall · Class II · ZOLL Medical Corporation
Key facts
| Recall number (Z-number) | Z-0977-2018 |
|---|---|
| Recall event | 79204 |
| Product | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor… |
| Product code | MKJ |
| Recalling firm | ZOLL Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2018 |
| 510(k) numbers | K110742 |
| FEI number | 1220908 |
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