Device evidence

device-recall:cfres:138256

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

Official recall number

Z-2098-2015

Evidence summary

Product code: HDX
Recall status: Terminated
Event initiated: June 19, 2015
Root cause: Incorrect or no expiration date
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2098-2015