—#214766

Product

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

FDA product code: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

Timeline

Recall initiated: 2025-06-12
Posted by FDA: 2025-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.