Medline Convenience Kits Recalled for Potential Sterility Breach Risk
Medline Convenience Kits containing BD ChloraPrep Clear applicators are recalled due to potential open seals on packaging that may compromise sterility and lead to infection risk during surgical procedures.
What this means for you
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: This is a Class II recall of a sterile medical device used in surgical procedures. Although no illnesses or injuries have been reported, a breach in sterile packaging poses significant risk of infection for surgical patients. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators labeled for C-section preparation (Reference number DYNJ32702B). The recall was initiated because the applicators may have open seals on their packaging, which could compromise the sterility of the product.
A breach in the sterile packaging barrier may allow the product to become contaminated, potentially exposing patients to harmful microorganisms during surgical procedures. This could result in post-surgical infections.
Affected kits with Lot Number 24EBR761 were distributed domestically in California, Florida, Pennsylvania, and Texas. Healthcare providers and facilities who received these kits should not use them for surgical preparation and should contact Medline Industries or their supplier.
The recalled product
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- infection-risk
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 (3)
- UDI/DI 10193489431070 (EA)
- 40193489431071 (CASE)
- Lot Numbers: 24EBR761
Distribution
Distribution scope not specified by the agency.
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