Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.

Recall Number: D-228-2013

Firm: CareFusion 213, LLC

Classification: Class II

Status: Terminated

Report Date: 20130403

Initiation Date: 20130304

Termination Date: 20140512

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.