Device recall
Z-2453-2025: BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock…
FDA device recall · Class II · BD SWITZERLAND SARL
Key facts
| Recall number (Z-number) | Z-2453-2025 |
|---|---|
| Recall event | 97070 |
| Product | BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal… |
| Product code | ONB |
| Recalling firm | BD SWITZERLAND SARL |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K123213, K130197, K140591, K181221, K201099 |
| FEI number | 3012798826 |
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