PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: November 19, 2014 Initiated: September 30, 2014 #Z-0208-2015

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

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
6 units
Distribution
US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by CooperSurgical, Inc.. Units affected: 6 units.
Why was this product recalled?
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2014. Severity: Low. Recall number: Z-0208-2015.