Recall Z-0253-2016— CooperSurgical, Inc.
Class III · Terminated
Class III FDA medical device recall by CooperSurgical, Inc., initiated 2015-09-14, terminated 2016-01-08. It names one FDA 510(k) clearance: K904774. 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.. 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..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-09-14
- Terminated
- 2016-01-08
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.