Medline Recalls Cataract Preop Kits with Potentially Contaminated Applicators
Medline is recalling specific lots of Cataract Preop Kits containing BD ChloraPrep Clear 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 (infection) from a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators, specifically the Cataract Preop Kit (Catalog Number DYKS1583A, Lot 24KBP388). The recall is a downstream action resulting from the manufacturer's recall of specific lots of the BD ChloraPrep Clear applicators.
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 product was distributed nationwide in the United States. Consumers and healthcare providers 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 CATARACT PREOP KIT DYKS1583A
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 222,653
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DYKS1583A UDI-DI 10198459146640 Lot 24KBP388
Distribution
Distributed nationwide across the United States.
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