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.
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