Coloplast Recalls Mislabeled Restorelle L Prostheses Due to Incorrect Instructions
Coloplast is recalling 111 units of Restorelle L prostheses because the packaging contains incorrect Instructions For Use pamphlets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect IFU) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling one lot of Restorelle L prostheses, catalog number 501440. The recall involves 111 units of the polypropylene mesh product manufactured by Coloplast A/S in Denmark.
The recall was initiated because the product is mislabeled. Specifically, the packaging includes an incorrect Instructions For Use (IFU) pamphlet. This labeling error could potentially lead to improper use of the medical device.
The affected units were distributed nationwide, including in Alabama, California, Colorado, the District of Columbia, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Missouri, New Hampshire, Ohio, Rhode Island, and Virginia. Consumers who possess this product should contact Coloplast for further instructions on how to proceed.
The recalled product
- Product
- Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
- Manufacturer
- Coloplast Manufacturing US, LLC
- Category
- Medical Device — Prosthetics
- Hazard
- Affected units
- 111
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)
- 3483171
Distribution
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