Device recall
Z-1702-2018: BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium…
FDA device recall · Class II · Bard Brachytherapy, Inc.
Key facts
| Recall number (Z-number) | Z-1702-2018 |
|---|---|
| Recall event | 79972 |
| Product | BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic… |
| Product code | KXK |
| Recalling firm | Bard Brachytherapy, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2020 |
| 510(k) numbers | K093663 |
| FEI number | 3002942387 |
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