Cardinal Health 200, LLC: 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.

Agency Publication Date: March 9, 2020

Affected Products

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.

Lot No. 15072015, Item Code 11832215 , Expires 06/20/2020.

Lot Numbers:

11832215

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.

Lot No. 15063001, Item Code 1183005, Expires 05/31/2020

Lot Numbers:

1183005

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.

Lot No. 15063004, Item Code 1182558, Expires 5/31/2020

Lot Numbers:

1182558

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.

Lot No. 15072024, Item Code 11811022F, Expires 06/20/2020

Lot Numbers:

11811022F

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84779

Status: Resolved

Manufacturer: Cardinal Health 200, LLC

Manufactured In: United States

Units Affected: 3 products (8400 each; 8000; 8000)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot No. 15072015, Item Code 11832215 , Expires 06/20/2020.

Lot Numbers:

11832215

Lot No. 15063001, Item Code 1183005, Expires 05/31/2020

Lot Numbers:

1183005

Lot No. 15063004, Item Code 1182558, Expires 5/31/2020

Lot Numbers:

1182558

Lot No. 15072024, Item Code 11811022F, Expires 06/20/2020

Lot Numbers:

11811022F