Reported Nov 18, 2015 · Terminated
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX…
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 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | MILEX PESSARY KIT |
| 2 | Model Numbers: MXPES00 |
| 3 | MXKPES00 |
| 4 | MXKPREG03 |
| 5 | MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. |
- Lot codes and dates
- MXPES00
Lot139411157299180533
- MXKPES00
Lot 125143142853
- MXKPREG03Lot 153096
- MXKPGSK07
Lot 157364160432
- MXPES00
- Amount recalled
- 144 units
Where it was sold
Why it was recalled
The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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