Device recall
Z-1038-2011: Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers…
FDA device recall · Class II · Apogee Medical
Key facts
| Recall number (Z-number) | Z-1038-2011 |
|---|---|
| Recall event | 57721 |
| Product | Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. |
| Product code | KMJ |
| Recalling firm | Apogee Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2012 |
| FEI number | 3011002629 |
At a glance
- None 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