Medications & Supplements/Prescription Drugs

ICU Medical Inc: Lactated Ringer's Injection Recalled for Iron Oxide Particulate Matter

Agency Publication Date: May 19, 2020

Summary

ICU Medical Inc. is recalling approximately 93,648 bags of Lactated Ringer's Injection, USP (1000 mL) distributed under the Hospira brand. This recall was initiated after a customer found particulate matter identified as iron oxide (rust) inside a flexible container. Because this is a prescription intravenous medication, the presence of foreign particles can lead to serious health complications. Consumers should immediately stop using the affected lot and contact their healthcare provider or pharmacist.

Risk

Injecting a solution containing iron oxide particles can cause local inflammation, granulomas (clumps of immune cells), or more severe issues like blood clots that may travel to the lungs, heart, or brain. These complications can be life-threatening if the particles block critical blood flow or cause an intense systemic inflammatory response.

What You Should Do

Check your medical supplies for Lactated Ringer's Injection, USP 1000 mL flexible containers with NDC 0409-7953-09.
Verify the lot number and expiration date on the individual container; this recall specifically affects Lot #: 07-514-FW with an expiration date of 01-JUL-2021.
Immediately stop using any product from the affected lot and quarantine the items to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to report any potential adverse reactions.
Return any unused product from the affected lot to the pharmacy or place of purchase for a refund and contact ICU Medical at 1-800-666-5177 for further return instructions.
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

Full Refund

Healthcare provider consultation and pharmacy refund

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 (1000 mL)

Model:

NDC 0409-7953-09

Recall #: D-1270-2020

Lot Numbers:

07-514-FW (Exp. 01-JUL-2021)

Date Ranges: Exp. 01-JUL-2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85625

Status: Resolved

Manufacturer: ICU Medical Inc

Sold By: Hospira, Inc.

Manufactured In: United States

Units Affected: 93,648 flexible container

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 · 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

Risk

What You Should Do

Check your medical supplies for Lactated Ringer's Injection, USP 1000 mL flexible containers with NDC 0409-7953-09.

Verify the lot number and expiration date on the individual container; this recall specifically affects Lot #: 07-514-FW with an expiration date of 01-JUL-2021.

Immediately stop using any product from the affected lot and quarantine the items to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to report any potential adverse reactions.

Return any unused product from the affected lot to the pharmacy or place of purchase for a refund and contact ICU Medical at 1-800-666-5177 for further return instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.