Recall Z-1686-2021
CooperSurgical, Inc. · initiated April 23, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot 280819
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.
FDA-determined 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.
Details
- Recall number
- Z-1686-2021
- Initiated
- April 23, 2021
- Product code
- HEW – Culdoscope (And Accessories)
- Quantity
- 6 boxes or 12 units
- Distribution
- Domestic: UT, OH, DE
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT