FDA Recall D-0266-2021

CareFusion 213, LLC · El Paso, TX

Class I — life-threatening Terminated 814 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

Lot / code: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0038209, Exp. 01/31/2023; 0098528, Exp. 02/28/2023.

Quantity: 36 cartons

Reason for recall

Microbial Contamination of Non-Sterile Products: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.

Recall record

Recall number: D-0266-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in Puerto Rico and Oman
Recall initiated: 2020-07-07
Classified by FDA Center: 2021-02-19
FDA published: 2021-03-03
Terminated: 2022-09-29
Recalling firm: CareFusion 213, LLC
Firm location: El Paso, TX

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