Recall Z-0253-2016 ยท HHW Pessary, Vaginal
CooperSurgical, Inc.
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.
| Date | Nov 10, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | Cooper Surgical sent an Urgent Medical Device Recall letter dated September 14, 2015 via FedEx with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Customers were asked to discontinue use of the affected products and complete the Acknowledgement and Receipt form for a free replacement. For questions contact Product Surveillance at 203.601.5200 ext. 3300. |
| Quantity | 144 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904774 | INGLAT-O-BALL Milex Products, Inc., Dec 7, 1990 |