Recall Z-0208-2015— CooperSurgical, Inc.

Name: FDA recall Z-0208-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Class III · Terminated

Class III FDA medical device recall by CooperSurgical, Inc., initiated 2014-09-30, terminated 2015-05-28. It names 2 FDA 510(k) clearances: K904774, K904026. 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. Reason: Incorrect expiration date printed on the MILEX PESSARY KIT packaging.

Recalling firm: CooperSurgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-09-30
Terminated: 2015-05-28
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

2 on FDA's record

K904774 — INGLAT-O-BALLMilex Products, Inc.·cleared 1990-12-07
K904026 — INFLAT-O-BALLMilex Products, Inc.·cleared 1990-10-10

K-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

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

Reason for recall

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

Data sourced from openFDA. This site is unofficial and independent of the FDA.