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U.S. Department of Health and Human Services

Class 3 Device Recall Cooper Surgical Cube Pessary 1 5/8"", 41mm.

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  Class 3 Device Recall Cooper Surgical Cube Pessary 1 5/8"", 41mm. see related information
Date Initiated by Firm February 26, 2013
Date Posted March 27, 2013
Recall Status1 Terminated 3 on March 04, 2014
Recall Number Z-1011-2013
Recall Event ID 64531
510(K)Number K904774  K904026  
Product Classification Pessary, vaginal - Product Code HHW
Product Cooper Surgical Cube Pessary 1 5/8"", 41mm.
Milex
Part Number: MXKPEC04

A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Code Information Lot Number:117376
Recalling Firm/
Manufacturer		 Cooper Surgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Same
203-601-9825
Manufacturer Reason
for Recall		 Pessary mislabeled outer package may not reflect the size of the product contained in the package
FDA Determined
Cause 2		 Packaging process control
Action Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974. For questions regarding this recall call 203-601-9825.
Quantity in Commerce 70 units
Distribution Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
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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