Device recall
Z-0442-2022: Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-0442-2022 |
|---|---|
| Recall event | 88998 |
| Product | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD… |
| Product code | KCT |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201945 |
| FEI number | 3007475226 |
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