FDA-Drug2012-10-10Class II
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Hazard
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Sold states
IL, MO, and NJ
Affected count
576 Cartons
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-004-2013More 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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