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CareFusion 213, LLC

FDA Regulatory Profile

Summary

Total Recalls
31 (13 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0243-2026Class IIBD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA),December 17, 2025
D-0441-2025Class IIBD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), PatieMay 15, 2025
D-0259-2025Class IBD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcoFebruary 14, 2025
D-1168-2023Class IIBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) SterilAugust 25, 2023
D-0373-2021Class IBD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v IsopApril 20, 2021
D-0345-2021Class IChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-SteMarch 19, 2021
D-0346-2021Class IChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-StMarch 19, 2021
D-0350-2021Class IIChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-StMarch 19, 2021
D-0349-2021Class IIChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-SteMarch 19, 2021
D-0347-2021Class IIBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) SterilMarch 19, 2021
D-0343-2021Class IBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) SterilMarch 19, 2021
D-0344-2021Class IBD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPAMarch 19, 2021
D-0348-2021Class IIBD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPAMarch 19, 2021
D-0266-2021Class IChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-StJuly 7, 2020
D-0267-2021Class IChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-SteJuly 7, 2020
D-0268-2021Class IBD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPAJuly 7, 2020
D-0265-2021Class IBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) SterilJuly 7, 2020
D-1510-2020Class IChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mLJune 23, 2020
D-1509-2020Class IBD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcJune 23, 2020
D-1511-2020Class IChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mLJune 23, 2020