FDA Recall
Open, Classified
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
Recall: Z-1686-2021
·
Initiated April 23, 2021
Recall
- Recall Number
- Z-1686-2021
- Event Number
- 87849
- Firm
- CooperSurgical, Inc.
- FEI Number
- 1216677
- Product Code
- HEW
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- April 23, 2021
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350
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
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.
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.
Distribution
Domestic: UT, OH, DE
Quantity
6 boxes or 12 units