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.

Recall Number: D-004-2013

Firm: Carefusion 213, Llc

Classification: Class II

Status: Terminated

Report Date: 20121010

Initiation Date: 20120423

Termination Date: 20130911

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

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.