Recall record at a glance
| Official record | Z-0208-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | CooperSurgical, Inc. |
| Report date | Nov 19, 2014 |
| Recall initiation date | Sep 30, 2014 |
| Quantity | 6 units |
| Location | Trumbull, CT, United States |
Official 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
Why the product was recalled
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Distribution information
US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.