Device recall
Z-1906-2010: FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF…
FDA device recall · Class II · Rochester Medical Corp
Key facts
| Recall number (Z-number) | Z-1906-2010 |
|---|---|
| Recall event | 55765 |
| Product | FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. |
| Product code | OCK |
| Recalling firm | Rochester Medical Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2011 |
| PMA numbers | P990002 |
| FEI number | 2130787 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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