Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 18 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.
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, which indicates the product is unlikely to cause adverse health consequences. The hazard is limited to packaging mislabeling regarding size.
Plain-English summary
Cooper Surgical, Inc. is recalling 18 units of the Incontinence Dish w/ Support Pessary #5, 80mm (Part Number: MXPCONDS05). The recall is due to a labeling error where the outer package may not accurately reflect the size of the pessary contained within.
The affected product is a medical device inserted into the vagina to provide support for the uterus, bladder, and rectum. The specific lot number is 117443. The units were distributed nationwide in the United States and internationally to Australia, Canada, Colombia, Denmark, France, Holland, New Zealand, and Thailand.
Consumers who have purchased this specific product should stop using it and contact Cooper Surgical, Inc. for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 18
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:117443
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cooper Surgical, 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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