Z-2098-2015 Class II Terminated
FDA device recall Z-2098-2015 was initiated by CooperSurgical, Inc. on Jun 19, 2015 and is designated Class II. Reason for recall: Incorrect expiration date on outer carton kit label The recall status is terminated (terminated Feb 1, 2016). Affected quantity: 40 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- Jun 19, 2015
- Termination Date
- Feb 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 kits
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
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.
Code Information
LOT 156966
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2098-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026