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MILEX
Coopersurgical, Inc. · Model MXKPGSS3-1/4 · UDI-DI 60888937007635
HHW
Prescription
10
510(k) clearances
575
Adverse events (1 deaths)
17
Recalls
37
Facilities
Description
KIT: Gellhorn with short stem Pessary; 3 1/4" (83mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-01-21 | CooperSurgical, Inc. | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length dis |
| 2019-05-02 | Rinovum Women's Health | The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses). |
| 2017-04-10 | CooperSurgical, Inc. | The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product a |
| 2015-09-14 | CooperSurgical, Inc. | 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 p |
| 2015-02-09 | CooperSurgical, Inc. | Incorrect size printed on the Milex Pessary Kit packaging label |
| 2014-09-30 | CooperSurgical, Inc. | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| 2014-09-30 | CooperSurgical, Inc. | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| 2013-02-26 | Cooper Surgical, Inc. | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| 2013-02-26 | Cooper Surgical, Inc. | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.