Carefusion 213, Llc recalls ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation
Recalled October 10, 2012 · FDA recall D-004-2013 · Carefusion 213
Hazard
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. · FDA Class II
Units
576 Cartons
Sold at
IL, MO, and NJ
Description
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Product
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.
Manufacturer(s)
Carefusion 213, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →