Device recall
Z-1018-2013: Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model…
FDA device recall · Class II · Cooper Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1018-2013 |
|---|---|
| Recall event | 64510 |
| Product | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception. |
| Product code | HDW |
| Recalling firm | Cooper Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2014 |
| 510(k) numbers | K063223 |
| FEI number | 1216677 |
At a glance
- 1–9 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