Reported Nov 19, 2014 · Terminated
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical…
CooperSurgical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 75 Vista Pl · Trumbull, CT · 06611-3934
Is this the product you have?
- CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1
- ModelMXKPRS01
- Product UsageThe 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
- Lot codes and dates
- Lot Number146351
- Amount recalled
- 17 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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