Device recall
Z-0037-2015: The Hulka Clip is a sterile packaged medical device that carries a two year…
FDA device recall · Class II · Richard Wolf Medical Instruments Corp.
Key facts
| Recall number (Z-number) | Z-0037-2015 |
|---|---|
| Recall event | 68777 |
| Product | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. |
| Product code | KNH |
| Recalling firm | Richard Wolf Medical Instruments Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2017 |
| PMA numbers | P870080 |
| FEI number | 1418479 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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