Device recall
Z-1661-2008: Kendall Calf Garment - Reprocessed Sterile device used to cover calf while…
FDA device recall · Class II · Ascent Healthcare Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1661-2008 |
|---|---|
| Recall event | 47343 |
| Product | Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. |
| Product code | JOW |
| Recalling firm | Ascent Healthcare Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2012 |
| 510(k) numbers | K012403 |
| FEI number | 1000132435 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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