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CareFusion 213, LLC FDA Recalls
30 recalls on file across drugs, 8 of them Class I and 20 still open. Matched by name to CFN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton,Class IIJul 9, 2026Lack of Assurance of Sterility: Affected product may exhibit |
| ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/cClass IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a)Class IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mLClass IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x Class IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/caseClass IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x Class IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5Class IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3mClass IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, Class IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL ApplicatorClass IIJun 11, 2026Lack of assurance of sterility: Unsterilized ChloraPrep & Pu |
| BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 ApplClass IMay 28, 2026Non-Sterility: Due to presence of Aspergillus penicillioides |
| BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 AppliClass IIMay 28, 2026Lack of Assurance of Sterility: Due to wrinkles in the paper |
| BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator,Class IIMay 28, 2026Lack of Assurance of Sterility: Due to wrinkles in the paper |
| BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, Class IMay 28, 2026Non-Sterility: Due to presence of Aspergillus penicillioides |
| BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mLClass IIApr 22, 2026Lack of assurance of Sterility: potential product contaminat |
| BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 flClass IIApr 22, 2026Lack of assurance of Sterility: potential product contaminat |
| BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL AClass IIDec 17, 2025Lack of Assurance of Sterlity |
| BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative SkinClass IIMay 15, 2025Lack of Assurance of Sterility: The affected product may exh |
| BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient PClass IFeb 14, 2025Non-Sterility: contamination of Aspergillus penicillioides, |
| BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (Class IIAug 25, 2023Stability data does not support expiry: Shelf-life of the im |
| BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA))Class IApr 20, 2021Defective Delivery System: An increase in complaints identif |
| ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Class IIMar 19, 2021CGMP Deviations: Product is being recalled because at label |
| BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl.Class IMar 19, 2021Non-sterility.Product is being recalled because at labeled s |
| ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -ClearClass IIMar 19, 2021CGMP Deviations: Product is being recalled because at label |
| BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution,Class IMar 19, 2021Non-sterility.Product is being recalled because at labeled s |
| ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -ClearClass IMar 19, 2021Microbial Contamination of Non-Sterile Product.Product is be |
| ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Class IMar 19, 2021Microbial Contamination of Non-Sterile Product:.Product is b |
| BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl.Class IIMar 19, 2021Lack of Assurance of Sterility: Product is being recalled b |
| BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution,Class IIMar 19, 2021Lack of Assurance of Sterility: Product is being recalled b |