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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

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  Class 2 Device Recall CooperSurgical MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 see related information
Date Initiated by Firm May 20, 2015
Date Posted June 18, 2015
Recall Status1 Terminated 3 on January 20, 2016
Recall Number Z-1814-2015
Recall Event ID 71329
510(K)Number K063223  
Product Classification Diaphragm, contraceptive (and accessories) - Product Code HDW
Product MILEX OMNIFLEX DIAPHRAGM SIZE 80
Model: MXWF80
Code Information Lot 153309
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Nana Banafo
203-601-5200 Ext. 3350
Manufacturer Reason
for Recall		 A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
FDA Determined
Cause 2		 Labeling mix-ups
Action CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .
Quantity in Commerce 200 units
Distribution AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
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 = HDW and Original Applicant = COOPERSURGICAL, INC.
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