Device recall
Z-0520-2013: STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation…
FDA device recall · Class II · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-0520-2013 |
|---|---|
| Recall event | 63758 |
| Product | STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle… |
| Product code | FRC |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2013 |
| 510(k) numbers | K103222 |
| FEI number | 3003662624 |
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