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.
Reason for recall: Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Recall initiated: 20120423
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated