CareFusion 213, LLC — Class II: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5%
CareFusion 213, LLC has initiated a Class II recall for BD PurPrep (Povidone-iodine 8.3% with isopropyl alcohol 72.5%) sterile solution due to a lack of sterility assurance and potential product contamination. The recall remains ongoing and affects the 10.5 mL applicator configuration under NDC 54365-014-41.
This recall affects CareFusion 213, LLC and its parent company Becton Dickinson and Co., as well as healthcare facilities, distributors, and pharmacy departments utilizing BD PurPrep sterile solution applicators.
A Class II classification indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences. For professional regulatory staff, this suggests a breakdown in the validated sterilization process or environmental controls during the manufacturing of aseptic topical products. The mention of 'potential product contamination' indicates that actual contamination may not have been confirmed in all units, but the integrity of the sterile barrier or process cannot be guaranteed.
Quality assurance teams should verify if any impacted NDC 54365-014-41 units remain in inventory and secure them according to established recall management procedures. A review of sterility assurance protocols for topical antiseptic manufacturing may be warranted to address potential contamination risks.
Class II. Reason: Lack of assurance of Sterility: potential product contamination. Product: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41. Firm: CareFusion 213, LLC (El Paso TX United States). Status: Ongoing.
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