Device recall
Z-1686-2021: The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-1686-2021 |
|---|---|
| Recall event | 87849 |
| Product | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2 |
| Product code | HEW |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K954311 |
| 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