85%Confidence
0Views
FDASource
2026-05-27Date
Summary
A second sterility issue for BD's PurPrep product amplifies quality control concerns, potentially leading to broader market share loss. Repeated failures may trigger FDA enforcement actions.
Actionable: Evaluate BD's corrective actions and potential litigation costs; reduce holdings if further recalls emerge.
AI Confidence: 85%
Data Points
firmCareFusion 213, LLC
classificationClass II
statusOngoing
distributionNationwide in the USA
productBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Caref
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