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U.S. Department of Health and Human Services

Class 3 Device Recall CooperSurgical

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  Class 3 Device Recall CooperSurgical see related information
Date Initiated by Firm September 30, 2014
Date Posted November 13, 2014
Recall Status1 Terminated 3 on May 28, 2015
Recall Number Z-0207-2015
Recall Event ID 69500
510(K)Number K904026  K904774  
Product Classification Pessary, vaginal - Product Code HHW
Product CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1
Model: MXKPRS01


Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Code Information Lot Number: 146351
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Vista Pl
Trumbull CT 06611-3934
For Additional Information Contact
203-601-5200
Manufacturer Reason
for Recall		 Incorrect expiration date printed on the MILEX PESSARY KIT packaging
FDA Determined
Cause 2		 Incorrect or no expiration date
Action CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. .
Quantity in Commerce 17 units
Distribution US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
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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