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Terminated

CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 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

FDA Recall Z-0207-2015 · Posted 2014-11-13

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHHW
Date Initiated2014-09-30
Date Terminated2015-05-28
Product Quantity17 units

Reason for Recall

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

Firm Action

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. .

Root Cause

Incorrect or no expiration date

Distribution Pattern

US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904774INGLAT-O-BALLMilex Products, Inc. · 1990-12-07K904026INFLAT-O-BALLMilex Products, Inc. · 1990-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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