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U.S. Department of Health and Human Services

Class 3 Device Recall Cooper Surgical Cube Pessary w/Drainage Holes 0"1", 25mm.

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 Class 3 Recall
Cooper Surgical Cube Pessary w/Drainage Holes 0"1", 25mm.
see related information
Date Posted March 27, 2013
Recall Status1 Terminated on March 04, 2014
Recall Number Z-1012-2013
Recall Event ID 64531
Premarket Notification
510(K) Numbers
K904026  K904774 
Product Classification Pessary, Vaginal - Product Code HHW
Product Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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:121784
Recalling Firm/
Manufacturer
Cooper Surgical, Inc.
75 Corporate Dr
Trumbull, Connecticut 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
PRODUCTION CONTROLS: 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 20 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HHW and Original Applicant = MILEX PRODUCTS, INC.
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