Device recall
Z-0087-2018: RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic…
FDA device recall · Class II · Epimed International
Key facts
| Recall number (Z-number) | Z-0087-2018 |
|---|---|
| Recall event | 77842 |
| Product | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter |
| Product code | OGE |
| Recalling firm | Epimed International |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2023 |
| 510(k) numbers | K053318 |
| FEI number | 1643059 |
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