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.
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-227-2013More CareFusion 213, LLC recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08CareFusion ChloraPrep FREPP applicators recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
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