Medline Convenience Kits Recalled for Potential Applicator Seal Defects
Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could lead to infection.
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 3/5 (High).
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: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for localized or systemic infection due to packaging defects.
Plain-English summary
Medline Industries, LP is recalling specific lots of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. The recall is a downstream action following the manufacturer's recall of the specific BD ChloraPrep Clear applicators contained within these kits.
The affected product may exhibit an open or incomplete seal on the packaging of the applicator. The use of a potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. A total of 222,653 units were distributed nationwide in the US.
Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI-DI codes listed in the recall notice. If the product is found, it should be removed from use and returned to Medline or the distributor according to their instructions.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
- Manufacturer
- Medline Industries, LP
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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