Device recall
Z-1481-2015: HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter…
FDA device recall · Class II · Catheter Research, Inc
Key facts
| Recall number (Z-number) | Z-1481-2015 |
|---|---|
| Recall event | 70948 |
| Product | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use. |
| Product code | HGS |
| Recalling firm | Catheter Research, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2015 |
| 510(k) numbers | K032835 |
| FEI number | 3008998256 |
At a glance
- 1–9 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