Device recall
Z-2098-2015: Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-2098-2015 |
|---|---|
| Recall event | 71582 |
| Product | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the… |
| Product code | HDX |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2016 |
| FEI number | 1216677 |
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