Medical Device Recall: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
MEDLINE INDUSTRIES, LP - Northfield · June 12, 2025
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.
Distribution
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Quantity Affected
48 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2156-2025
Status: ongoing
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