Medline Convenience Kits Recalled Due to 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.
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: The recall involves a risk of harm (infection) from a defective medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. The recall is a downstream action following a manufacturer recall of the specific BD applicator lots included in these kits. The affected products were distributed nationwide in the United States.
The recall is being issued because the packaging of the applicators may exhibit an open or incomplete seal. This defect could allow contamination 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.
Healthcare facilities and consumers should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Medline Industries, LP according to their instructions.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
- Manufacturer
- Medline Industries, LP
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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