Device recall
Z-0627-2016: Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD…
FDA device recall · Class II · Bayer Healthcare
Key facts
| Recall number (Z-number) | Z-0627-2016 |
|---|---|
| Recall event | 72817 |
| Product | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. |
| Product code | FRN |
| Recalling firm | Bayer Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2016 |
| 510(k) numbers | K100798 |
| FEI number | 2520313 |
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