Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects
Medline is recalling specific lots of convenience kits containing BD ChloraPrep applicators due to potential packaging seal defects that could allow contamination.
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 contamination.
Plain-English summary
Medline Industries, LP is recalling specific lots 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 concerns. The affected products include Patient Admin Kits (DYKA1384B, DYKA1384C) and Welcome Kits (DYKS1206D).
The recall is due to the possibility that the packaging of the applicators may exhibit an open or incomplete seal. If the seal is compromised, the applicator may be contaminated. 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 United States. Consumers and healthcare facilities should stop using the affected products and contact Medline Industries, LP for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
- Manufacturer
- Medline Industries, LP
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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