CooperSurgical, Inc. recalls Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silic…

Recall date

June 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2098-2015

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.

Why it was recalled

Incorrect expiration date on outer carton kit label

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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