Device recall
Z-1493-2011: Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached…
FDA device recall · Class II · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-1493-2011 |
|---|---|
| Recall event | 57827 |
| Product | Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal… |
| Product code | DRX |
| Recalling firm | ConMed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2014 |
| 510(k) numbers | K901555 |
| FEI number | 3001451571 |
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