RecallWatchUSA

Home / Recalls / Medical Devices

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

Recalled July 29, 2015 · FDA recall Z-2098-2015 · CooperSurgical

Hazard
Incorrect expiration date on outer carton kit label · FDA Class II
Units
40 kits
Sold at
US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.

Description

Incorrect expiration date on outer carton kit label

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
Manufacturer(s)
CooperSurgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov