Device recall
Z-2390-2008: Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex…
FDA device recall · Class II · Apogee Medical, Inc
Key facts
| Recall number (Z-number) | Z-2390-2008 |
|---|---|
| Recall event | 49027 |
| Product | Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. |
| Product code | GBM |
| Recalling firm | Apogee Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2009 |
| 510(k) numbers | K992137 |
| FEI number | 3007829657 |
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