FDA-Device2025-07-30Class II
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Affected count
48 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2025Don't want to check this manually?
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