Class 2 Device Recall CooperSurgical

• Date Initiated by Firm: June 19, 2015
• Date Posted: July 17, 2015
• Recall Status: Terminated 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/ Manufacturer: CooperSurgical, Inc.; 75 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: SAME; 203-601-5200
• Manufacturer Reason for Recall: Incorrect expiration date on outer carton kit label
• FDA Determined Cause: 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.