Device product
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
Z-0208-2015
Product summary
- Event
- Event 69500
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0208-2015
Official wording
Reason: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Code information: Lot Number: 142921
Distribution pattern: US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Derived failure modes
-
Unknown
Incorrect expiration date printed on the MILEX PESSARY KIT packaging