Device recall
Z-0628-2011: ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER…
FDA device recall · Class II · Advanced Sterilization Products
Key facts
| Recall number (Z-number) | Z-0628-2011 |
|---|---|
| Recall event | 57281 |
| Product | ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes. |
| Product code | KOG |
| Recalling firm | Advanced Sterilization Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 30, 2013 |
| 510(k) numbers | K832458 |
| FEI number | 3003662624 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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