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Critical RiskFDA Device
Medical Devices

Cardinal Health 200, LLC: Monoject Syringes Recalled for Infusion Pump Compatibility Issues

Agency Publication Date: October 26, 2023
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Summary

Cardinal Health 200, LLC is recalling approximately 16.6 million Monoject syringes because they may not be recognized by or compatible with syringe infusion pumps. This defect occurs because the syringes have different dimensions than those previously validated for use with these pumps, which can lead to pump errors, failure to recognize the syringe, or incorrect medication delivery. These luer-lock tip syringes were distributed nationwide across the United States in various sizes ranging from 1 mL to 60 mL.

Risk

If an infusion pump does not recognize the syringe or is incompatible with its dimensions, it may result in an interruption of therapy, under-dosing, or over-dosing of critical medications. This poses a significant risk to patients who rely on precise delivery of life-sustaining fluids and drugs.

What You Should Do

  1. Check your medical supplies for Monoject Luer-Lock Tip Soft Pack Syringes in sizes 1 mL, 6 mL, 12 mL, 20 mL, 35 mL, and 60 mL.
  2. Verify if your product is affected by matching the product codes and lot numbers. For example, 1 mL syringes (Code 1180100777) include lots 221201 through 230601, and 60 mL syringes (Code 1186000777T) include lots 221101 and 230601.
  3. Inspect the UDI/DI barcode on the packaging. Affected 6 mL syringes have the case UDI 50192253034606, while 20 mL syringes have the case UDI 50192253034675.
  4. If you are using these syringes with an infusion pump, contact your healthcare provider or the manufacturer immediately to ensure the syringe is compatible with your specific pump model.
  5. Contact Cardinal Health 200, LLC or your healthcare provider for further instructions regarding the use of these syringes and potential replacement or refund options.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Compatibility evaluation and instructions

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
Product: Monoject 6 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
1180600777
UPC Codes:
10192253034608
20192253034605
50192253034606
Lot Numbers:
221201
221202
221203
221204
221205
230201
230202
230203
230204
230205
230206
230207
Product: Monoject 12 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
1181200777T
UPC Codes:
10192253025811
20192253025818
50192253025819
Lot Numbers:
221101
221102
221103
221104
Product: Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
1182000777
UPC Codes:
10192253034677
20192253034674
50192253034675
Lot Numbers:
221201
221202
221203
221204
221205
230201
230202
230203
230204
230205
230206
Product: Monoject 35 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
1183500777
UPC Codes:
10192253034691
20192253034698
50192253034699
Lot Numbers:
221201
230201
230601
230602
Product: Monoject 60 mL Syringe Luer-Lock Tip Soft Pack
Model / REF:
1186000777T
UPC Codes:
10192253025835
20192253025832
50192253025833
Lot Numbers:
221101
230601

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93075
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: medical supply distributors
Manufactured In: United States
Units Affected: 6 products (3,113,846 units; 3,936,682 units; 3,084,300 units; 4,913,520 units; 1,097,048 units; 457,200 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 ยท 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.