CareFusion 213, LLC: Drug Recall

Recall #D-0373-2021 · 04/20/2021

Class I: Dangerous

Recall Details

Recall Number: D-0373-2021
Classification: Class I
Product Type: Drug
Recalling Firm: CareFusion 213, LLC
Status: Terminated
Date Initiated: 04/20/2021
Location: El Paso, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 707,050 eaches

Reason for Recall

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Product Description

BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38

Distribution Pattern

Nationwide within the United States

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 I: Dangerous 02/14/2025

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.