Device recall
Z-0340-2009: STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software…
FDA device recall · Class II · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-0340-2009 |
|---|---|
| Recall event | 50073 |
| Product | STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. |
| Product code | MLR |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2011 |
| 510(k) numbers | K023290, K991999 |
| 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