Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
FDA device recall Z-2153-2025 · posted 2025-07-21 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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.
- Action taken
- On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 960 units
- Distribution
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- Date initiated
- 2025-06-12
- Date posted
- 2025-07-21
- Location
- Northfield, IL
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