FDA-Drug2013-04-03Class II
Blood Culture Prep Kit II 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 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.
CareFusion 213, LLC
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.
Sold states
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Affected count
929,000 kits
Manufactured in
1550 Northwestern Drive, El Paso, TX, United States
Products
Blood Culture Prep Kit II 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 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-227-2013Don't want to check this manually?
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