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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

ICU Medical Inc: Dextrose and Sodium Chloride Injections Recalled for Potential Sterility Issues

Agency Publication Date: November 2, 2018
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Summary

ICU Medical Inc. is recalling approximately 2.9 million bags of 5% Dextrose Injection and 0.9% Sodium Chloride Injection because the bags may leak. These intravenous (IV) fluids are distributed nationwide under the Hospira brand in various sizes ranging from 25 mL to 250 mL. Because the bags may leak, there is no longer a guarantee that the fluid inside is sterile, which can lead to serious health complications if administered to a patient.

Risk

A leaking bag can allow bacteria or other contaminants to enter the IV fluid. If these non-sterile fluids are injected into a patient, it could result in life-threatening infections or other severe systemic reactions.

What You Should Do

  1. Identify if you have the 5% Dextrose Injection (Hospira) by checking for NDC 0409-7923-20 (25 mL) with lot 84-017-JT (Exp. Dec 01, 2019) or NDC 0409-7922-02 (250 mL) with lot 84-012-JT (Exp. June 01, 2019).
  2. Identify if you have the 0.9% Sodium Chloride Injection (Hospira) by checking for NDC 0409-7983-02 (250 mL, lots 84-011-JT, 85-014-JT), NDC 0409-7983-61 (150 mL, lot 84-015-JT), NDC 0409-7984-36 (50 mL, lot 84-016-JT), or NDC 0409-7984-37 (100 mL, lots 84-005-JT, 84-014-JT).
  3. Immediately stop using any IV bags from the affected lot numbers and quarantine them to prevent use.
  4. Contact your healthcare provider or pharmacist immediately if you have administered or received product from these lots to discuss potential health concerns.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact ICU Medical Inc at 600 N Field Drive, Lake Forest, IL 60045 for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and guidance for affected medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 5% Dextrose Injection, USP, Rx Only (25 mL)
Model:
NDC 0409-7923-20
Lot Numbers:
84-017-JT (Exp. December 01, 2019)
Date Ranges: Expiration December 01, 2019
Product: 5% Dextrose Injection, USP, Rx Only (250 mL)
Model:
NDC 0409-7922-02
Lot Numbers:
84-012-JT (Exp. June 01, 2019)
Date Ranges: Expiration June 01, 2019
Product: 0.9% Sodium Chloride Injection, USP Rx Only (250 mL)
Model:
NDC 0409-7983-02
Lot Numbers:
84-011-JT (Exp. December 01, 2019)
85-014-JT (Exp. January 01, 2020)
Date Ranges: Expiration December 01, 2019, Expiration January 01, 2020
Product: 0.9% Sodium Chloride Injection, USP Rx Only (150 mL)
Model:
NDC 0409-7983-61
Lot Numbers:
84-015-JT (Exp. December 01, 2019)
Date Ranges: Expiration December 01, 2019
Product: 0.9% Sodium Chloride Injection, USP Rx Only (50 mL)
Model:
NDC 0409-7984-36
Lot Numbers:
84-016-JT (Exp. June 01, 2019)
Date Ranges: Expiration June 01, 2019
Product: 0.9% Sodium Chloride Injection, USP Rx Only (100 mL)
Model:
NDC 0409-7984-37
Lot Numbers:
84-005-JT (Exp. December 01, 2019)
84-014-JT (Exp. December 01, 2019)
Date Ranges: Expiration December 01, 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81199
Status: Resolved
Manufacturer: ICU Medical Inc
Sold By: Hospitals; Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 2 products (372,912 bags; 2,580,448 bags)
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.

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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.