PlainRecalls
FDA Drug Moderate 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.

Reported: July 23, 2014 Initiated: June 13, 2013 #D-1442-2014

Product 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.

Reason for Recall

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

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
23,000 Applicators
Distribution
Nationwide in U.S.
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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 by CareFusion 213, LLC. Units affected: 23,000 Applicators.
Why was this product recalled?
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 23, 2014. Severity: Moderate. Recall number: D-1442-2014.