CooperSurgical, Inc. Recall 87849
Description: 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
CooperSurgical, Inc. Recall 87849 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1686-2021 |
| Event ID | 87849 |
| Event Description | 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 Type | Devices |
| Distribution | Domestic: UT, OH, DE |
| Quantity | 6 boxes or 12 units |
| Recall 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. |
| Device Classification | 20210602 |
| Device Code Info | Lot 280819 |
| Center Classification Date | 20210526 |
| Recall Initiation Date | 20210423 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
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