Device recall
Z-0208-2015: CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model…
FDA device recall · Class III · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-0208-2015 |
|---|---|
| Recall event | 69500 |
| Product | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment… |
| Product code | HHW |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 28, 2015 |
| 510(k) numbers | K904026, K904774 |
| FEI number | 1216677 |
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