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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 Drug
Medications & Supplements/Prescription Drugs

ICU Medical Inc: Lactated Ringer's and Sodium Chloride Injection Recalled for Particulate Matter

Agency Publication Date: November 6, 2019
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Summary

ICU Medical Inc is recalling approximately 448,272 bags of intravenous (IV) fluids, specifically Lactated Ringer's Injection (500 mL) and 0.9% Sodium Chloride Injection (250 mL), due to the presence of particulate matter found in the solution. These products are used for fluid and electrolyte replacement in patients via intravenous administration. The recall includes Hospira brand bags distributed nationwide that have reached or passed their expiration dates in 2019 and 2020. Consumers should contact their healthcare provider or pharmacist immediately if they believe they have been administered these products or have them in their possession.

Risk

The presence of particulate matter in an injectable medication can cause serious health complications. When administered into the bloodstream, these particles can cause inflammation, infection, or blockages in blood vessels, which may lead to life-threatening issues such as organ damage or blood clots.

What You Should Do

  1. Check your medical supplies for LACTATED RINGER'S Injection, USP, 500 mL flexible containers (NDC 0409-7953-03) with lot number 84-603-FW and an expiration date of 01 DEC 2019.
  2. Check for 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Containers (NDC 0409-7983-25) with lot number 95-101-C6 and an expiration date of 01 MAY 2020.
  3. Immediately stop using any products that match the identified lot numbers and NDC codes.
  4. Contact your healthcare provider or pharmacist for guidance on alternative treatments and to report any adverse health effects.
  5. Return any unused bags of the recalled injection fluids to the place of purchase for a full refund.
  6. Contact ICU Medical Inc directly for further instructions on returning products or for additional details regarding this recall at their headquarters in Lake Forest, Illinois.
  7. For further questions or to report a related health concern, call 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 for unused recalled IV fluid bags.

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

Affected Products

Product: LACTATED RINGER'S Injection, USP (500 mL flexible container)
Model:
NDC 0409-7953-03
Recall #: D-0349-2020
Lot Numbers:
84-603-FW (Exp. 01 DEC 2019)
Date Ranges: Expired 01 DEC 2019
Product: 0.9% SODIUM CHLORIDE INJECTION, USP (250 mL VisIV Container)
Model:
NDC 0409-7983-25
Recall #: D-0350-2020
Lot Numbers:
95-101-C6 (Exp. 01 MAY 2020)
Date Ranges: Expired 01 MAY 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84144
Status: Resolved
Manufacturer: ICU Medical Inc
Sold By: Hospira, Inc.; Healthcare facilities; Hospitals
Manufactured In: United States
Units Affected: 2 products (389,808 bags; 58,464 bags)
Distributed To: Nationwide
Agency Last Updated: November 15, 2019

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.