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
- Company
- Coopersurgical, Inc.
- Recall Initiated
- April 23, 2021
- Recall Number
- Z-1686-2021
- Quantity
- 6 boxes or 12 units
- Firm Location
- Trumbull, CT
Reason for Recall
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.
Distribution
Domestic: UT, OH, DE
Lot / Code Info
Lot 280819
Root Cause
Labeling design
Action Taken
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.
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