MILEX PESSARY KIT recalled over labeling errors

Recall date

September 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CooperSurgical, Inc. recalls MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILIC…

Recall number

Z-0253-2016

FDA classification

Class III

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.