Device recall
Z-0423-2021: 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be…
FDA device recall · Class II · 3M Company - Health Care Business
Key facts
| Recall number (Z-number) | Z-0423-2021 |
|---|---|
| Recall event | 86519 |
| Product | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 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