RecallDepth
Class I Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

Company
Carefusion 213, Llc
Recall Initiated
July 7, 2020
Posted
March 3, 2021
Recall Number
D-0267-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
280 cartons
Firm Location
El Paso, TX, United States

Reason for Recall

Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Distribution

Distributed in Puerto Rico and Oman

Lot / Code Info

All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022

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