Device recall
Z-0454-2015: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY…
FDA device recall · Class I · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-0454-2015 |
|---|---|
| Recall event | 69752 |
| Product | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device. |
| Product code | MKJ |
| Recalling firm | ConMed Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 30, 2017 |
| 510(k) numbers | K014209 |
| FEI number | 3001451571 |
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