Key Takeaway

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. by Carefusion 213, Llc was recalled on June 13, 2013. The hazard: Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

FDA Drug Class II Terminated

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Recalled: June 13, 2013 ~23,000 Applicators units affected D-1442-2014

Description

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Hazard / Reason

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

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 With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Drugs

Company Information

Carefusion 213, Llc

El Paso, TX, United States

View all 30 recalls by Carefusion 213, Llc →

Distribution

Nationwide in U.S.

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April 20, 2021
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Frequently Asked Questions

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What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

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