CareFusion 213, LLC — Class II: ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcoh
CareFusion 213, LLC initiated a Class II recall for ChloraPrep FREPP applicators because unsterilized units intended for further processing were distributed to customers outside of the designated distribution channel. The recall affects product units (NDC 54365-400-30) that lacked assurance of sterility at the time of distribution.
CareFusion 213, LLC, its parent company Becton, Dickinson and Co., and healthcare facilities or distributors who received ChloraPrep FREPP (2% CHG / 70% IPA) 1.5 mL applicators labeled as Catalog number 930599NSB.
This event indicates a failure in distribution control and material segregation protocols. For regulatory and QA professionals, it highlights the risk of "intended for further processing" inventory entering the commercial supply chain prematurely. Such errors suggest a potential gap in the handover between manufacturing stages and logistics, where non-sterile bulk or WIP materials were likely misidentified as finished, sterile stock.
Verify that all non-sterile work-in-progress (WIP) materials intended for downstream sterilization are physically partitioned and electronically locked within the ERP system to prevent inadvertent distribution. Review distribution channel controls for products that require further processing prior to end-user sale.
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: ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB. Firm: CareFusion 213, LLC (El Paso TX United States). Status: Ongoing.
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