FDASeptember 14, 2015device
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
coopersurgical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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