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Terminated

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

FDA Recall Z-2098-2015 · Posted 2015-07-17

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHDX
Date Initiated2015-06-19
Date Terminated2016-02-01
Product Quantity40 kits

Reason for Recall

Incorrect expiration date on outer carton kit label

Firm Action

CooperSurgical sent an Urgent Medicall Device Recall dated June 19, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt Form for a replacement. For questions call 203.601.5200.

Root Cause

Incorrect or no expiration date

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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