Recall Z-0208-2015 ยท HHW Pessary, Vaginal
CooperSurgical, Inc.
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 incontin
| Date | Nov 13, 2014 (initiated Sep 30, 2014) |
| Status | Terminated |
| Reason | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| Root cause | Incorrect or no expiration date |
| Action | CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. . |
| Quantity | 6 units |
| Distribution | US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL |
| FDA record | Open on fda.gov |