ChloraPrep With Tint (CareFusion) – Aspergillus Contamination (2020)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Brand
CareFusion 213, LLC
Lot Codes / Batch Numbers
Lot #: 7194739, Exp. 06/25/2020, 7214841, Exp. Date 07/17/2020, 7213558, Exp. Date 07/16/2020, 7227839, Exp. Date 07/30/2020, 7276589, Exp. Date 09/20/2020, 7198824, Exp. Date 06/29/2020, 7275718, Exp. Date 09/19/2020, 7289776, Exp. Date 09/30/2020, 7306916, Exp. Date 10/12/2020, 8011665, Exp. Date 12/14/2020, 8015801, Exp. Date 12/18/2020, 8031857, Exp. Date 01/31/2021, 8033645, Exp. Date 01/31/2021, 8127657, Exp. Date 04/30/2021, 8137527, 8157141, 8158638, Exp. Date 05/31/2021, 8164530, Exp. Date 06/30/2021, 8220737, Exp. Date 07/31/2021, 8235991, Exp. Date 08/31/2021, 8043978, Exp. Date 01/31/2021, 8306694, Exp. Date 10/31/2021, 8334983, Exp. Date 11/30/2021, 9031893, 9038599, 9042938, Exp. Date 01/31/2022, 9051563, 9053560, 9072856, Exp. Date 02/28/2022, 9086532, Exp. Date 03/31/2022, 9137904, Exp. Date 05/31/2022, 9087985, Exp. Date 03/31/2022, 9191256, 9168975, Exp. Date 06/30/2022, 9218464, 9218595, Exp. Date 07/31/2022, 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022, 9269603, Exp. Date 09/30/2022, 9296395, 9295914, 9311076, Exp. Date 10/31/2022, 9316348, 9324565, 9345911, Exp. Date 11/30/2022, 9305775, Exp. Date 10/31/2022, 0011737, Exp. Date 12/31/2022, 0023790, 0037279, Exp. Date 01/31/2023.
Products Sold
Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; 9269603, Exp. Date 09/30/2022; 9296395, 9295914, 9311076, Exp. Date 10/31/2022; 9316348, 9324565, 9345911, Exp. Date 11/30/2022; 9305775, Exp. Date 10/31/2022; 0011737, Exp. Date 12/31/2022; 0023790, 0037279, Exp. Date 01/31/2023.
CareFusion 213, LLC is recalling ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL due to Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 7, 2026