Device recall
Z-0253-2016: MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07…
FDA device recall · Class III · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-0253-2016 |
|---|---|
| Recall event | 72204 |
| Product | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. |
| Product code | HHW |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 8, 2016 |
| 510(k) numbers | 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