Device recall
Z-0133-2024: THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0133-2024 |
|---|---|
| Recall event | 93074 |
| Product | THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy. |
| Product code | ONB |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2523676 |
At a glance
- None 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