Device recall
Z-1393-2011: Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used…
FDA device recall · Class II · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-1393-2011 |
|---|---|
| Recall event | 56367 |
| Product | Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. |
| Product code | KCT |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2012 |
| 510(k) numbers | K951295 |
| 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