FDAHealthJune 12, 2025
MEDLINE INDUSTRIES, LP - Northfield — Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
⚠️ Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- June 12, 2025
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
What's affected?
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
- Lot code
- 24EBR549
Additional details
UDI/DI 10888277797819 (EA), 40888277797810 (CASE), Lot Numbers: 24EBR549
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 184 units.
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