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

The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators that may not be sterile.

Medline has sent letters to customers on June 12 and June 20 advising them to immediately check inventory, quarantine any affected kits, remove the BD ChloraPrep applicators, and apply over‑labels indicating the component must be discarded before use.

The letters also instruct distributors and downstream recipients to notify their own customers of the recall communication. Other components in the kits can still be used.

The FDA will continue to monitor the situation and update the alert page as new information becomes available.