Device recall
Z-1996-2014: Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage…
FDA device recall · Class II · RGI Medical Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-1996-2014 |
|---|---|
| Recall event | 68552 |
| Product | Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures. |
| Product code | FPA |
| Recalling firm | RGI Medical Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2016 |
| 510(k) numbers | K001599 |
| FEI number | 3004994611 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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