IV Start Kit Recall Gets FDA's Most Serious Class I Rating Over Fungus in Skin Prep Applicators

The Food and Drug Administration posted a Class I classification on Sept. 14 for a recall of a hospital IV start kit containing a skin prep applicator from a lot contaminated with a fungus.

Class I is the FDA's most serious recall category. The agency uses it when there is a reasonable chance of serious health problems or death. The contamination itself has been known since June. The classification is what is new.