Recall Z-0208-2015
CooperSurgical, Inc. · initiated September 30, 2014
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Codes / lots: Lot Number: 142921
Reason for recall
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
FDA-determined cause: Incorrect or no expiration date
Action taken
CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. .
Details
- Recall number
- Z-0208-2015
- Initiated
- September 30, 2014
- Posted by FDA
- November 13, 2014
- Terminated
- May 28, 2015
- Product code
- HHW – Pessary, Vaginal
- Quantity
- 6 units
- Distribution
- US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0207-2015 Class III | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01…Incorrect expiration date printed on the MILEX PESSARY KIT packaging | 09/30/2014Terminated |