CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 17 MILEX Pessary Kits because the packaging displays an incorrect expiration date.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a packaging labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
CooperSurgical, Inc. is recalling 17 units of the MILEX PESSARY KIT-Ring w/Support Folding Pessary- #1 (Model: MXKPRS01). The recall was initiated because an incorrect expiration date was printed on the product packaging.
The affected units are identified by Lot Number 146351. These devices were distributed in the United States to the states of Ohio, California, Wisconsin, Washington, Florida, Minnesota, New Hampshire, Rhode Island, Massachusetts, Illinois, Michigan, Iowa, and Alabama.
The MILEX Pessary is a silicone device used to manage gynecologic issues, including pelvic support defects and stress urinary incontinence. Consumers who possess this specific lot of the product should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- 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 inc
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 146351
Distribution
Part of a larger recall action
This product is one of 2 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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