Device recall
Z-0420-2021: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage…
FDA device recall · Class II · 3M Company - Health Care Business
Key facts
| Recall number (Z-number) | Z-0420-2021 |
|---|---|
| Recall event | 86519 |
| Product | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total). |
| Product code | DRX |
| Recalling firm | 3M Company - Health Care Business |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2022 |
| 510(k) numbers | K970796 |
| FEI number | 2110898 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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