Z-0208-2015 Class III Terminated
FDA device recall Z-0208-2015 was initiated by CooperSurgical, Inc. on Sep 30, 2014 and is designated Class III. Reason for recall: Incorrect expiration date printed on the MILEX PESSARY KIT packaging The recall status is terminated (terminated May 28, 2015). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 19, 2014
- Initiation Date
- Sep 30, 2014
- Termination Date
- May 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Reason for Recall
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Distribution Pattern
US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Code Information
Lot Number: 142921
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0208-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026