On Oct. 13, the FDA classified Medline's removal of certain convenience kits containing recalled BD ChloraPrep skin-prep applicators as a Class I recall, the agency's most serious type, according to the FDA recall notice for Medline kits. Customers are being told to quarantine and destroy the entire kit, not just the applicator inside. The concern is possible contamination with the fungus Aspergillus penicillioides.
Convenience kits bundle several items used during a procedure into one package, so a single recalled part can take a whole kit out of service. As of Aug. 17, Medline had not reported any serious injuries or deaths linked to the issue, the FDA said.
