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

• Date Initiated by Firm: May 20, 2015
• Date Posted: June 18, 2015
• Recall Status: Terminated 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: 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