Medline Convenience Kit Skin Lesion Set Potential Seal Defect
Medline is recalling its Skin Lesion Set convenience kits due to potential open or weak seals on breather pouches used for packaging. The compromised seals may affect the sterility of the kits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 FDA classified this as a Class II recall, and the source text does not report any illnesses, injuries, or deaths. The hazard is a packaging defect with potential for sterility compromise but no documented adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling the Skin Lesion Set (Model Number MNS6270, Lot Number 24KBD496) convenience kits due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile kits.
The affected kits have been distributed worldwide, including across the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. A total of 48 units are involved in this recall.
Compromised seals on the packaging may affect the sterility assurance of the convenience kits. Consumers or healthcare facilities in possession of affected kits should stop using them and contact Medline Industries for further instructions regarding return or replacement.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 48
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 (4)
- 1) MNS6270
- UDI-DI: 10653160220893(each)
- 40653160220894(case)
- Lot Number: 24KBD496
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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