Medline Convenience Kits with BD ChloraPrep Applicators Recalled Over Sterility Concerns
Medline Convenience Kits containing BD ChloraPrep Clear applicators are being recalled due to potential open seals in packaging that could compromise sterility and lead to infection.
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 recall involves a risk-of-harm medical device with potential for infection due to sterility breach. No illnesses or injuries have been reported. The FDA classified this as Class II without reported hospitalizations, placing it in the High severity category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Convenience Kits (model IV START KIT LAB DRAW-SH, Reference CDS860014P) that contain BD ChloraPrep Clear 1-milliliter applicators. The recalled kits have UDI/DI numbers 10888277797819 and case number 40888277797810, with lot number 24EBR549.
The BD ChloraPrep Clear applicators contained in these kits may exhibit open seals on the applicator packaging. A seal breach could compromise the sterility of the applicator, potentially leading to bacterial contamination and infection if the applicator is used on a patient.
These kits were distributed domestically to healthcare facilities in California, Florida, Pennsylvania, and Texas. No kits were distributed internationally. A total of 184 units were affected.
The recalled product
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- infection
- contamination
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 10888277797819 (EA)
- 40888277797810 (CASE)
- Lot Numbers: 24EBR549
Distribution
Distribution scope not specified by the agency.
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