Medline Skin Lesion Convenience Kits Recalled for Compromised Packaging Seals
Medline Industries is recalling Skin Lesion convenience kits (Model MNS6270, Lot 24KBD496) due to potential open or weak seals on breather pouches. The defective seals may compromise the integrity of the sterile medical kits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall involving packaging integrity of sterile medical kits. No illnesses or injuries have been reported. The recall addresses a risk-of-harm product where the hazard is theoretical—compromised seals could compromise sterility—but no actual injuries have been documented, placing it at the High severity level per the rubric.
Plain-English summary
Medline Industries, LP is recalling Skin Lesion convenience kits (Model MNS6270, Lot 24KBD496) due to potential open or weak seals on breather pouches used for packaging. The recall affects approximately 48 units.
Compromised seals on the breather pouches may allow the sterile contents to become contaminated or degraded, creating a potential safety issue for the medical kits.
The recalled kits were distributed worldwide, including throughout the United States and in Canada, Mexico, Panama, and the Virgin Islands.
Healthcare facilities and consumers who have received these kits should contact Medline Industries regarding the recall for further instructions.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-failure
- contamination-risk
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.
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