CareFusion 213, LLC Provisional
FDA Flags (21)
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton,
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a)
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/c
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case,
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3m
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Appli
Classification: Class II
Class II RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator,
Classification: Class II
Class I RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Appl
Classification: Class I
Class I RecallJul 2026
CareFusion 213, LLC
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator,
Classification: Class I
Class II RecallMay 2026
CareFusion 213, LLC
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl
Classification: Class II
Class II RecallMay 2026
CareFusion 213, LLC
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL
Classification: Class II
Class II RecallJan 2026
CareFusion 213, LLC
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL A
Classification: Class II
Class II RecallMay 2025
CareFusion 213, LLC
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin
Classification: Class II
Class I RecallMar 2025
CareFusion 213, LLC
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient P
Classification: Class I
Class II RecallSep 2023
CareFusion 213, LLC
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (
Classification: Class II