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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical

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  Class 2 Device Recall CooperSurgical see related information
Date Initiated by Firm June 19, 2015
Date Posted July 17, 2015
Recall Status1 Terminated 3 on February 01, 2016
Recall Number Z-2098-2015
Recall Event ID 71582
Product Classification Dilator, vaginal - Product Code HDX
Product Milex Vaginal-Hymenal Silicone Dilators Set of 4
P/N MX20

Product Usage:
The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice
Code Information LOT 156966
Recalling Firm/
CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Incorrect expiration date on outer carton kit label
FDA Determined
Cause 2
Incorrect or no expiration date
Action CooperSurgical sent an Urgent Medicall Device Recall dated June 19, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt Form for a replacement. For questions call 203.601.5200.
Quantity in Commerce 40 kits
Distribution US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
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.