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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgcial

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  Class 2 Device Recall CooperSurgcial see related information
Date Initiated by Firm February 09, 2015
Date Posted March 03, 2015
Recall Status1 Terminated 3 on January 15, 2016
Recall Number Z-1239-2015
Recall Event ID 70502
510(K)Number K904026  
Product Classification Pessary, vaginal - Product Code HHW
Product CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm
Part Number: MXKPEC02
Code Information Lot numbers: 144351, 142789 
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Same
203-601-5200
Manufacturer Reason
for Recall		 Incorrect size printed on the Milex Pessary Kit packaging label
FDA Determined
Cause 2		 Error in labeling
Action CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.
Quantity in Commerce 95 units
Distribution Nationwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HHW and Original Applicant = MILEX PRODUCTS, INC.
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