Medications & Supplements/Prescription Drugs

ICU Medical Inc: 0.9% Sodium Chloride Injection Recalled for Manufacturing Process Deviations

Agency Publication Date: February 19, 2019

Summary

ICU Medical Inc. is recalling 475,320 bags of 0.9% Sodium Chloride Injection (USP 1000 mL flexible container) due to Current Good Manufacturing Practice (CGMP) deviations. This product, commonly known as normal saline, is a prescription medication used for fluid and electrolyte replacement. The recall affects Hospira, Inc. branded bags with NDC 0409-7983-09 and lot number 91-016-JT. While no specific injuries or contamination incidents were reported in the data, manufacturing deviations can compromise the quality and safety of injectable medications.

Risk

Failure to follow standard manufacturing practices for injectable drugs could result in products that are not sterile or do not meet potency standards, potentially leading to infections or ineffective treatment for patients receiving intravenous fluids.

What You Should Do

Immediately check your medical supplies for 0.9% Sodium Chloride Injection, USP 1000 mL flexible containers with NDC 0409-7983-09.
Verify if your product belongs to Lot 91-016-JT with an expiration date of July 01, 2020.
If you identify an affected product, stop using it immediately and quarantine the item to prevent accidental use.
Contact your healthcare provider or pharmacist for guidance regarding alternative saline supplies.
Return any unused product from the affected lot to the place of purchase for a refund and contact ICU Medical Inc. for further instructions.
For additional information or to report concerns, 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 return.

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

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1000 mL)

Model:

NDC 0409-7983-09

Recall #: D-0509-2019

Lot Numbers:

91-016-JT (Exp. July 01, 2020)

Date Ranges: July 01, 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82048

Status: Resolved

Manufacturer: ICU Medical Inc

Sold By: Hospira, Inc.; hospitals; clinics

Manufactured In: United States

Units Affected: 475320 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.

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

What You Should Do

Immediately check your medical supplies for 0.9% Sodium Chloride Injection, USP 1000 mL flexible containers with NDC 0409-7983-09.

Verify if your product belongs to Lot 91-016-JT with an expiration date of July 01, 2020.

If you identify an affected product, stop using it immediately and quarantine the item to prevent accidental use.

Contact your healthcare provider or pharmacist for guidance regarding alternative saline supplies.

Return any unused product from the affected lot to the place of purchase for a refund and contact ICU Medical Inc. for further instructions.

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