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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 Electrosurgery see related information
Date Initiated by Firm April 23, 2021
Create Date May 26, 2021
Recall Status1 Open3, Classified
Recall Number Z-1686-2021
Recall Event ID 87849
510(K)Number K954311  
Product Classification Culdoscope (and accessories) - Product Code HEW
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
Code Information Lot 280819
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer 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
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.
Quantity in Commerce 6 boxes or 12 units
Distribution Domestic: UT, OH, DE
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HEW and Original Applicant = COOPERSURGICAL, INC.
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