Device recall
Z-0439-2013: Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The…
FDA device recall · Class II · Cooper Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0439-2013 |
|---|---|
| Recall event | 63681 |
| Product | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include… |
| Product code | LKF |
| Recalling firm | Cooper Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2014 |
| 510(k) numbers | K932115 |
| 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