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

FDA recall notice · announced August 26, 2020 · Carefusion 213

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

Notes

Distribution: Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Lot/code information: 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.
Quantity: 2,800,800 applicators
Status: Terminated
Products in this recall event:
- BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subs (D-1509-2020)
- ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC (D-1511-2020)
- 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 (D-1510-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.