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U.S. Department of Health and Human Services

Class 2 Device Recall 3.0 cm Ultem Polymeric Resin Koh Cup for Electrosurgery

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 Class 2 Device Recall 3.0 cm Ultem Polymeric Resin Koh Cup for Electrosurgerysee related information
Date Initiated by FirmApril 23, 2021
Create DateMay 26, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1686-2021
Recall Event ID 87849
510(K)NumberK954311 
Product Classification Culdoscope (and accessories) - Product Code HEW
ProductThe 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
Code Information Lot 280819
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer 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 2		Labeling design
ActionOn 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 in Commerce6 boxes or 12 units
DistributionDomestic: UT, OH, DE
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HEW
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