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 (medical device) where the hazard is potential infection due to contamination, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. The affected products include the Deluxe Pre Op Kit (DYKS2018), General Preop Kit (DYKS1584A), Pre Op Kit (DYKS1216I), and Pre-Op Kit (DYKM1398B). The recall is a downstream action following a manufacturer recall of the specific BD ChloraPrep applicators contained within these kits.
The recall is issued because the packaging of the affected applicators may exhibit an open or incomplete seal. This defect could potentially allow contamination of the applicators. 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. Specific lot numbers and UDI-DI codes are listed in the official recall documentation. Users should stop using the affected kits and contact Medline Industries, LP for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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