Device recall
Z-2337-2012: STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX…
FDA device recall · Class III · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-2337-2012 |
|---|---|
| Recall event | 62925 |
| Product | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate… |
| Product code | MLR |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 8, 2013 |
| 510(k) numbers | 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