The Recall Desk

FDA (Drugs) recall action 86998

CareFusion 213, LLC recalled 4 products on 2021-03-03

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-03-03
Critical
0
Units
1,704

Why these products were recalled

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.

Non-sterility: 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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Drugs)··2021-03-03

    CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.

    Product
    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-03-03

    FDA Recalls Chloraprep One-Step Due to Potential Fungal Growth

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.

    Product
    CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-03-03

    FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk

    CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.

    Product
    CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-03-03

    CareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk

    CareFusion 213, LLC is recalling non-sterile ChloraPrep With Tint solution distributed in Puerto Rico and Oman due to potential fungal contamination.

    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
    Category
    Distribution
    1 state