PlainRecalls
FDA Drug Critical Class I Ongoing

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

Reported: March 19, 2025 Initiated: February 14, 2025 #D-0259-2025

Product Description

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

Reason for Recall

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
205,440 applicators
Distribution
Nationwide and Canada
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.. Recalled by CareFusion 213, LLC. Units affected: 205,440 applicators.
Why was this product recalled?
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 19, 2025. Severity: Critical. Recall number: D-0259-2025.