Cardinal Health 200, LLC: Monoject Tuberculin Syringes Recalled for Incompatibility with IV Connectors

Agency Publication Date: October 13, 2023

Summary

Cardinal Health is recalling approximately 3.9 million Monoject 1 mL Tuberculin Syringes with Luer-Lock tips. These syringes feature a conical tip design that is not compatible with certain needleless intravenous (IV) connectors, which can prevent the secure connection needed for medication delivery. The affected products include model number 1180100777 and were distributed nationwide to healthcare facilities across 44 states.

Risk

The incompatible tip can lead to an insecure connection with IV lines, potentially causing medication leaks, air bubbles entering the bloodstream, or a complete failure to deliver necessary medicine to the patient.

What You Should Do

Locate your Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack packaging and identify the Model Number or Product Code 1180100777.
Check the box, case, or individual syringe wrap for the following affected Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, or 230601.
Verify the UDI/DI barcode numbers on the packaging: 10192253034530 (individual), 20192253034537 (box), or 50192253034538 (case).
If your syringes match these model or lot numbers, contact your healthcare provider or the manufacturer, Cardinal Health, at 1-888-463-6332 for further instructions and potential refund or replacement.
For additional questions regarding this recall, contact the FDA medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

Model / REF:

1180100777

UPC Codes:

10192253034530

20192253034537

50192253034538

Lot Numbers:

221201

221202

221203

230201

230202

230203

230204

230205

230601

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93019

Status: Active

Manufacturer: Cardinal Health 200, LLC

Sold By: Hospital and clinical distributors

Manufactured In: United States

Units Affected: 3.927,994 units

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

What You Should Do

Locate your Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack packaging and identify the Model Number or Product Code 1180100777.

Check the box, case, or individual syringe wrap for the following affected Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, or 230601.

Verify the UDI/DI barcode numbers on the packaging: 10192253034530 (individual), 20192253034537 (box), or 50192253034538 (case).

If your syringes match these model or lot numbers, contact your healthcare provider or the manufacturer, Cardinal Health, at 1-888-463-6332 for further instructions and potential refund or replacement.

For additional questions regarding this recall, contact the FDA medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.