Key Takeaway

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11 by Becton Dickinson & Company was recalled on September 15, 2017. The hazard: Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep wit...

FDA Drug Class II Terminated

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

Recalled: September 15, 2017 ~628,000 applicators units affected D-0029-2018

Description

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

Hazard / Reason

Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

Drugs

Company Information

Becton Dickinson & Company

Franklin Lakes, NJ, United States

View all 1 recalls by Becton Dickinson & Company →

Distribution

IL, MO, PA, TN, & VA

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Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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Where can I find the original recall notice?

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