Medline Convenience Kits Recalled for Potential ChloraPrep Applicator Contamination
Medline is recalling convenience kits containing BD ChloraPrep 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 the hazard is potential infection, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. This is a downstream recall initiated because the manufacturer of the applicators recalled specific lots due to quality issues.
The affected product may exhibit an open or incomplete seal on the packaging of the applicator. The use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
The affected products were distributed nationwide in the United States. Users should check their inventory for the specific lot numbers and UDI-DI codes listed in the recall notice and stop using any affected products.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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