CareFusion 213, LLC — Class II: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl
CareFusion 213, LLC (a subsidiary of BD) has initiated a Class II recall for BD ChloraPrep Hi-Lite Orange (CHG 2% and IPA 70%) applicators. The recall was prompted by the distribution of unsterilized applicators to customers outside of the intended distribution channel, when these units were intended for further processing and sterilization.
This affects CareFusion 213, LLC, its parent company Becton, Dickinson and Company, and healthcare facilities or distributors that received the specific NDC and catalog numbers of these topical antiseptic applicators. It also concerns supply chain and quality professionals responsible for sterility assurance.
The distribution of unsterilized medical products intended for a sterile clinical environment presents a significant regulatory and safety risk. This event suggests a failure in distribution controls or inventory segregation between bulk intermediate products and finished goods. Regulatory teams may view this as a breakdown in the quality management system's ability to prevent the diversion of non-conforming or unfinished product into the commercial stream.
Quality and supply chain teams should immediately verify that BD ChloraPrep products in their inventory were obtained through authorized channels and match sterilized catalog numbers. Procurement departments must audit distribution pathways for products requiring further processing to ensure unsterilized bulk units have not been diverted into clinical use.
Class II. Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel. Product: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.. Firm: CareFusion 213, LLC (El Paso TX United States). Status: Ongoing.
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