Medline Blood Culture Kits Recalled Due to Potential Seal Defects
Medline is recalling blood culture 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 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 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear 1mL Applicators (Blood Culture Kit 2 W/Connect, code DYNDH1487A). This is a downstream recall initiated because the manufacturer of the BD ChloraPrep applicators recalled specific lots due to quality concerns.
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.
The recall covers lots 25AMD225, 25BMA495, 25GMD834, 25HMJ685, 26AMD781, 26DMI370, 26FMG952, and 26FMJ739. The product was distributed nationwide in the United States. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
- Manufacturer
- Medline Industries, LP
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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