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All Recalls

Every Carefusion 213, Llc Recall

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32 recalls
High RiskFDA
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. oz. (10.5 mL) x...
Drugs·0 affected·Apr 22, 2026
High RiskFDA
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 Applicators per ...
Drugs·0 affected·Apr 22, 2026
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFu...
Drugs·106,400 affected·Dec 17, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Ste...
Drugs·385,200 affected·May 15, 2025
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin ...
Drugs·205,440 affected·Feb 14, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 ap...
Drugs·398,160 affected·Aug 25, 2023
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution...
Drugs·707,050 affected·Apr 20, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·11,115,774 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·952,100 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·7,990,100 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·1,434,000 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·14,275,400 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·24,969,700 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·6,869,400 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·40,720,900 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·36 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·988 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ...
Drugs·400 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·280 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 app...
Drugs·2,800,800 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Appl...
Drugs·12,500 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Pa...
Drugs·4,272,300 affected·Jun 23, 2020
High RiskFDA
Carefusion 213, Llc
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
Drugs·20,556,000 affected·Oct 24, 2014
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Onl...
Drugs·23,000 affected·Jun 13, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0...
Drugs·8,960,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged ...
Drugs·46,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170...
Drugs·698,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per...
Drugs·544,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-coun...
Drugs·3,032,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit...
Drugs·929,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators...
Drugs·576 affected·Apr 23, 2012
High RiskFDA
Carefusion 213, Llc
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 26...
Drugs·67,775 affected·Nov 8, 2011