Device 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
Z-2098-2015
Product summary
- Event
- Event 71582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-2098-2015
Official wording
Reason: Incorrect expiration date on outer carton kit label
Code information: LOT 156966
Distribution pattern: US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
Derived failure modes
-
Unknown
Incorrect expiration date on outer carton kit label