REGULATORY INTELLIGENCE·Recall
CareFusion 213, LLC Initiates Class I Recall of ChloraPrep Applicators Due to Non-Sterility
CareFusion 213, LLC has initiated a Class I recall of 205,440 BD ChloraPrep Clear 1mL Applicators due to Aspergillus penicillioides contamination from package lidding breach. This poses a severe patient safety risk, demanding immediate action from procurement and supply chain leaders to secure alternative sterile preoperative skin preparations and reassess supplier quality protocols for critical medical supplies.
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