FDA-Device2015-07-29Class II
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
CooperSurgical, Inc.
Hazard
Incorrect expiration date on outer carton kit label
Sold states
US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
Affected count
40 kits
Manufactured in
75 Corporate Dr, N/A, Trumbull, CT, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2015Don't want to check this manually?
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