Recall Z-1686-2021 ยท HEW Culdoscope (And Accessories)
CooperSurgical, Inc.
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
| Date | Apr 23, 2021 |
| Status | Open, Classified |
| Reason | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. |
| Root cause | Labeling design |
| Action | On 04/30/2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Cooper Surgical is issuing this recall due to a labeling discrepancy with respect to the cup size, where a 3.5cm Ultem Cup was placed in the Product rather than a 3.0cm Ultem Cup as indicated by the Part Number on the packaging label. |
| Quantity | 6 boxes or 12 units |
| Distribution | Domestic: UT, OH, DE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954311 | KOH COLPOTOMIZER SYSTEM CooperSurgical, Inc., Nov 19, 1996 |