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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Cardinal Health 200, LLC: Monoject Insulin Syringes Recalled for IV Connector Incompatibility

Agency Publication Date: November 8, 2024
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Summary

Cardinal Health is recalling 371,326 units of the Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack due to incompatibility with needleless Intravenous (IV) connectors. These specific syringes, which are identified by REF number 1188100777, may not connect properly to IV lines, potentially leading to delays in medication delivery or leakage. Consumers should contact their healthcare provider or Cardinal Health to determine if their stock is affected and for further instructions regarding a remedy.

Risk

The syringes have demonstrated an inability to properly interface with needleless IV connectors, which can prevent the successful administration of IV push insulin. This failure could result in the patient receiving an incorrect dose of insulin or experiencing a significant delay in treatment.

What You Should Do

  1. Check your medical supplies for the Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, specifically REF 1188100777.
  2. Identify if your products are part of the affected lots by looking for UDI/DI 10192253034783 (Lot 221201), UDI/DI 20192253034780 (Lot 230201), or UDI/DI 50192253034781 (Lot 230202).
  3. Confirm the expiration dates on the packaging, which include November 30, 2027 (Lot 221201), January 31, 2028 (Lot 230201), and February 1, 2028 (Lot 230202).
  4. Stop using these specific syringes for the administration of IV push insulin through needleless connectors immediately.
  5. Contact your healthcare provider or the manufacturer, Cardinal Health, at their Waukegan, IL location for further instructions regarding the return or replacement of these syringes.
  6. For additional questions or to report issues, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Discontinue use for IV push insulin via needleless connectors.

How to: Cardinal Health recommends that these specific lots not be used for administration of IV push insulin via needleless connector. Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Model / REF:
1188100777
UPC Codes:
10192253034783
20192253034780
50192253034781
Lot Numbers:
221201 (Exp. 2027-11-30)
230201 (Exp. 2028-01-31)
230202 (Exp. 2028-02-01)
Date Ranges: Expiration dates: 2027-11-30, 2028-01-31, 2028-02-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95487
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Authorized distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 371,326 units
Distributed To: Nationwide

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.