Device recall
Z-1009-2013: Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number…
FDA device recall · Class III · Cooper Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1009-2013 |
|---|---|
| Recall event | 64531 |
| Product | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. |
| Product code | HHW |
| Recalling firm | Cooper Surgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 4, 2014 |
| 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