CareFusion 213, LLC recalls FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP)
Recalled April 3, 2013 · FDA recall D-229-2013 · CareFusion 213
Hazard
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. · FDA Class II
Units
544,500 kits
Sold at
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Description
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Product
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
Manufacturer(s)
CareFusion 213, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →