FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits

FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile.

Medline sent a letter on June 12 advising customers to check inventory, quarantine affected kits, and apply over‑labels stating the BD ChloraPrep component must be removed and discarded before use. Other components in the kits may still be used.

Distributors and anyone who has resold the product are instructed to notify downstream users. The FDA continues to review the issue and will provide updates as significant new information becomes available.