The Recall Desk

FDA (Devices) recall action 84779

Cardinal Health 200, LLC recalled 4 products on 2020-03-18

The FDA (Devices) 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
2020-03-18
Critical
0
Units
24,400

Why these products were recalled

Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

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

  • HighFDA (Devices)··2020-03-18

    Cardinal Health Recalls Non-Sterile Hypodermic Safety Needles

    Cardinal Health is recalling Monoject Hypodermic Safety Needles that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.

    Product
    Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Syringes with Safety Needles

    Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.

    Product
    Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Hypodermic Safety Needles

    Cardinal Health is recalling Monoject Hypodermic Safety Needles because they were shipped as non-sterile despite labeling indicating sterility, posing an infection risk.

    Product
    Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Bluntfill Syringes

    Cardinal Health 200, LLC is recalling Monoject Bluntfill syringes that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.

    Product
    Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Distribution
    48 states