Recall Z-2098-2015 ยท HDX Dilator, Vaginal
CooperSurgical, Inc.
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
| Date | Jul 17, 2015 (initiated Jun 19, 2015) |
| Status | Terminated |
| Reason | Incorrect expiration date on outer carton kit label |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.