Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators

Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile.

The agency says the devices could cause temporary or reversible health issues and, though unlikely, more serious problems. The correction does not require removal of the kits from use, but the affected applicators must be taken out.

Medline advises customers to quarantine stock, remove the BD ChloraPrep applicators, and apply over-labels indicating the component must be discarded before use. Distributors and downstream recipients should be notified.

The FDA continues to monitor the situation and will update the public as needed.