FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators

The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits.

Medline has sent a letter to customers telling them to remove from use and destroy any convenience kits that contain the recalled BD ChloraPrep applicators because of a risk of fungal contamination.

The kits affected are Medline Convenience Kits that include BD ChloraPrep Clear 1 mL single sterile applicators (Item 930480, lot 4032183) and FREPP Clear 1.5 mL applicators with paper lidding (Item 930299, lot 4073005).

Users are instructed to review inventory, quarantine the kits, complete response forms and then destroy the entire kit.

The current guidance supersedes an earlier June 12, 2026 notice that had advised over-labeling the kits; now full destruction is required.