Recall Z-2098-2015— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-06-19, terminated 2016-02-01. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Incorrect expiration date on outer carton kit label.
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-19
- Terminated
- 2016-02-01
- Firm location
- Trumbull, CT, United States
Product description
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
Reason for recall
Incorrect expiration date on outer carton kit label
Data sourced from openFDA. This site is unofficial and independent of the FDA.