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

Agency Publication Date: November 13, 2019

Summary

ICU Medical Inc is recalling approximately 389,808 bags of Lactated Ringer's Injection, USP (500 mL) due to the possible presence of particulate matter in the solution. This prescription veterinary medication, distributed under the Hospira, Inc. brand, was sold nationwide in the United States. Consumers should immediately stop using the affected bags and contact their veterinarian or healthcare provider regarding the safety of their animals.

Risk

The presence of particulate matter in an injectable solution can cause serious health issues, including inflammation, allergic reactions, or blockages in the blood vessels (embolisms), which can be life-threatening.

What You Should Do

Check your inventory for Lactated Ringer's Injection, USP 500 mL bags with the NDC number 0409-7953-03.
Identify if your product belongs to Lot 84-603-FW with an expiration date of 01-DEC-2019.
Immediately stop using any products identified from the affected lot.
Contact your veterinarian or healthcare provider to discuss the health of any animals that may have received this medication and for guidance on alternative treatments.
Return any unused product to the place of purchase (pharmacy or distributor) for a refund and contact ICU Medical Inc for further instructions regarding the return process.
For additional questions or to report a concern, contact the FDA at 1-888-INFO-FDA.

Your Remedy Options

Full Refund

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

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

Affected Products

Product: Lactated Ringer's Injection, USP (500 mL)

Model:

NDC 0409-7953-03

V-0348-2020

Lot Numbers:

84-603-FW (Exp. 01-DEC-2019)

Date Ranges: Exp. 01-DEC-2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84226

Status: Resolved

Manufacturer: ICU Medical Inc

Sold By: Hospira, Inc.

Manufactured In: United States

Units Affected: 389,808 bags

Distributed To: Nationwide

Agency Last Updated: January 23, 2020

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

Summary

What You Should Do

Check your inventory for Lactated Ringer's Injection, USP 500 mL bags with the NDC number 0409-7953-03.

Identify if your product belongs to Lot 84-603-FW with an expiration date of 01-DEC-2019.

Immediately stop using any products identified from the affected lot.

Contact your veterinarian or healthcare provider to discuss the health of any animals that may have received this medication and for guidance on alternative treatments.

Return any unused product to the place of purchase (pharmacy or distributor) for a refund and contact ICU Medical Inc for further instructions regarding the return process.

For additional questions or to report a concern, contact the FDA at 1-888-INFO-FDA.

Your Remedy Options

Full Refund

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

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