CareFusion 213, LLC — Class II: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (
CareFusion 213, LLC has initiated a Class II recall for BD ChloraPrep Clear 1 mL Applicators due to wrinkles in the paper lidding. This packaging defect may compromise the seal area, resulting in a lack of assurance of sterility for the 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol solution.
This affects CareFusion 213, LLC and its parent company Becton, Dickinson and Co., specifically regarding the manufacturing and distribution of sterile topical antiseptic applicators. It involves professionals in supply chain, hospital procurement, and clinical operations using NDC 54365-400-31.
This recall highlights the critical nature of primary packaging integrity in maintaining the validated sterile state of drug-device combination products. A breach in the seal area due to manufacturing process variations (wrinkling) necessitates a Class II designation, suggesting that while the risk of serious adverse health consequences is low, the product no longer meets its labeled sterility specifications. For regulatory professionals, this underscores the importance of packaging validation and in-process controls for heat-sealed lidding.
QA and Manufacturing teams should evaluate seal integrity inspection protocols, specifically focusing on visual inspection parameters for paper lidding wrinkles. Regulatory and Clinical teams should review existing inventory for affected NDC codes and ensure the recall management process is active for ongoing status updates.
Class II. Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.. Product: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.. Firm: CareFusion 213, LLC (El Paso TX United States). Status: Ongoing.
Open in openFDA / FDA.gov