Recall Z-0253-2016
CooperSurgical, Inc. · initiated September 14, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432
Reason for recall
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.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0253-2016
- Initiated
- September 14, 2015
- Posted by FDA
- November 10, 2015
- Terminated
- January 8, 2016
- Product code
- HHW – Pessary, Vaginal
- 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.
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT