Device recall
Z-0746-2014: STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S…
FDA device recall · Class II · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-0746-2014 |
|---|---|
| Recall event | 67043 |
| Product | STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments. |
| Product code | FLF |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2014 |
| 510(k) numbers | K023290 |
| 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