CareFusion 213, LLC: Drug Recall

Recall Details

Recall Number

D-0259-2025

Classification

Class I

Product Type

Drug

Recalling Firm

CareFusion 213, LLC

Status

Ongoing

Date Initiated

02/14/2025

Location

El Paso, TX, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

205,440 applicators

Reason for Recall

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

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.

Distribution Pattern

Nationwide and Canada

Other Recalls by CareFusion 213, LLC

• Class II: Risk 12/17/2025
  Lack of Assurance of Sterlity
• Class II: Risk 05/15/2025
  Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
• Class II: Risk 08/25/2023
  Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
• Class I: Dangerous 04/20/2021
  Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
• Class I: Dangerous 03/19/2021
  Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

View all recalls by CareFusion 213, LLC →