Device recall
Z-2643-2023: B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2643-2023 |
|---|---|
| Recall event | 92910 |
| Product | B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02 |
| Product code | FMF |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K063280 |
| FEI number | 2523676 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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