Device recall
Z-0086-2017: 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the…
FDA device recall · Class II · Epimed International, Inc.
Key facts
| Recall number (Z-number) | Z-0086-2017 |
|---|---|
| Recall event | 74018 |
| Product | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia |
| Product code | BSP |
| Recalling firm | Epimed International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2018 |
| 510(k) numbers | K072005 |
| FEI number | 1316297 |
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