FDA-Device2014-11-19Class III
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 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
CooperSurgical, Inc.
Hazard
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Sold states
US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Affected count
17 units
Manufactured in
75 Vista Pl, Trumbull, CT, United States
Products
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0207-2015Don't want to check this manually?
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