Device recall
Z-0147-2012: Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot #…
FDA device recall · Class II · Medrad Inc
Key facts
| Recall number (Z-number) | Z-0147-2012 |
|---|---|
| Recall event | 60240 |
| Product | Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy. |
| Product code | DXT |
| Recalling firm | Medrad Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| 510(k) numbers | K023183 |
| FEI number | 2520313 |
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